Evidence Based Birth

Group B Strep in Pregnancy: Evidence for Antibiotics and Alternatives

Group B Strep in Pregnancy: Evidence for Antibiotics and Alternatives

© By Rebecca Dekker, PhD, RN, APRN.

What is Group B Strep?

Group B Streptococcus (GBS) is a type of bacteria that can cause illness in people of all ages. In newborns, GBS is a major cause of meningitis (infection of the lining of the brain and spinal cord), pneumonia (infection of the lungs), and sepsis (infection of the blood) (CDC 1996; CDC 2005; CDC 2009).

Group B strep lives in the intestines and migrates down to the rectum, vagina, and urinary tract. All around the world, anywhere from 10-30% of pregnant women are “colonized” with or carry GBS in their bodies (Johri et al. 2006). Using a swab of the rectum and vagina, women can test positive for GBS temporarily, on-and-off, or persistently (CDC 2010).

Being colonized with GBS does not mean that a woman will develop a GBS infection. Most women with GBS do not have any GBS infections or symptoms. However, GBS can cause urinary tract infections, pre-term birth, and GBS infections in the newborn (Valkenburg-van den Berg et al. 2009; CDC 2010).

In this article, I will focus on Group B Strep in pregnancy in the United States, along with some information about other countries.

Are some women more likely to carry GBS?

Researchers have looked at the risk factors for GBS in young, non-pregnant women (Feigin, Cherry et al. 2009). Women with these factors may be more likely to carry GBS:

  •  African-American
  •  Multiple sexual partners
  •  Male-to-female oral sex
  •  Frequent or recent sex
  •  Tampon use
  •  Infrequent handwashing
  •  Less than 20 years old

How often do newborns become infected with GBS?

Ashley's baby was born with an early GBS infection. Ashley tested positive for GBS but her doctor's office forgot to give her the test results. As a result, she did not receive antibiotics during labor.

Ashley’s baby was born with an early GBS infection. Ashley tested positive for GBS but her doctor’s office forgot to give her the test results. As a result, she did not receive antibiotics during labor.

There are 2 main types of GBS infection in newborns: early infection and late infection. In this article we will focus on early infection, which occurs in the first 7 days after birth. When a baby has an early GBS infection, symptoms usually appear within the first 12 hours, and almost all babies will have symptoms within 24-48 hours (CDC 2010). In a study of 148,000 infants born between 2000 and 2008, almost all of the 94 infants who developed early GBS infection were diagnosed within an hour after birth—suggesting that early GBS infection probably begins before birth (Tudela et al. 2012).

Early infection is caused by direct transfer of GBS from the mother to the baby, usually after the water breaks. The bacteria travel up from the vagina into the amniotic fluid, and the fetus may accidentally swallow some of the bacteria into the lungs—leading to an early GBS infection. Babies can also get GBS on their body (skin and mucous membranes) as they travel down the birth canal. However, most of these “colonized” infants stay healthy (CDC 2010).

In 1993-1994, the American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics recommended screening all pregnant women for GBS and treating GBS-positive women with intravenous (IV) antibiotics during labor. Since that time, we have seen a remarkable drop in early GBS infection rates in the U.S.—from 1.7 cases per 1,000 births in the early 1990’s, to 0.25 cases per 1,000 births today (CDC 2012).

If a mother who carries GBS is not treated with antibiotics during labor, the baby’s risk of becoming colonized with GBS is approximately 50% and the risk of developing a serious, life-threatening GBS infection is 1 to 2% (Boyer & Gotoff 1985; CDC 2010; Feigin, Cherry et al. 2009). As I noted earlier, being colonized is not the same thing as having an early GBS infection– most colonized babies stay healthy.

On the other hand, if a woman with GBS is treated with antibiotics during labor, the risk of her infant developing an early GBS infection drops by 80%. So for example, her risk could drop from 1% down to to 0.2%. (Ohlsson 2013)

What is the risk of death if the baby has an early GBS infection?

This photo was taken in 1985 of a baby boy who was diagnosed with a meningitis GBS infection during his first day of life. This was before antibiotics were given during labor for GBS. According to his mom, this baby was a "fighter" and miraculously survived. He was diagnosed with a seizure disorder at the age of 11.

This photo was taken in 1985 of a baby boy who was diagnosed with a meningitis GBS infection during his first day of life. This was before antibiotics were given during labor for GBS. According to his mom, this baby was a “fighter” and miraculously survived. He was diagnosed with a seizure disorder at the age of 11.

Researchers have estimated that the death rate from early GBS infection is 2 to 3% for full-term infants. This means of 100 babies who have an actual early GBS infection, 2-3 will die. Death rates from GBS are much higher (20-30%) in infants who are born at less than 33 weeks gestation (CDC 2010).

Although the death rate of GBS is relatively low, infants with early GBS infections can have long, expensive stays in the intensive care unit. Researchers have also found that up to 44% of infants who survive GBS with meningitis end up with long-term health problems, including developmental disabilities, paralysis, seizure disorder, hearing loss, vision loss, and small brains. Very little is known about the long-term health risks of infants who have GBS without meningitis, but some may have long-term developmental problems (Feigin, Cherry et al. 2009; Libster et al. 2012).

Are some newborns more likely to get early GBS disease?

The primary risk factor for early GBS infection is when the mother carries GBS. However, there are some things that increase the risk of early GBS infection:

*These are the major risk factors. About 60% infants who develop early GBS infection have no major risk factors, except for the fact that their mothers carry GBS (Schrag et al. 2002).

How accurate is testing for GBS?

Sarah chose not to get tested for GBS and gave birth at home without antibiotics.

Sarah chose not to get tested for GBS and gave birth at home without antibiotics.

The CDC recommends measuring GBS with a culture test at 35-37 weeks of pregnancy. This is done by swabbing the rectum and vagina with a Q-tip, and then waiting to see if GBS grows. It takes about 48 hours to get the results back. The goal is to get the results back before labor begins (CDC, 2010).

A culture test during labor is considered the “gold standard,” but this method is not used in practice because it takes too long to get results back. In a recent, high-quality study, researchers did the culture test twice– once at 35-36 weeks and once during labor. They compared the 35-36 week test to the gold standard.

Of the women who screened negative for GBS at 35-36 weeks, 91% were still GBS-negative when the gold standard test was done during labor. The other 9% became GBS positive. These 9% were “missed” GBS cases, meaning that these women had GBS, but most (41 out of 42) did not receive antibiotics.

Of the women who screened positive for GBS at 35-36 weeks, 84% were still GBS positive when the gold standard test was done during labor. However, 16% of the GBS-positive women became GBS-negative by the time they went into labor. These 16% received unnecessary antibiotics (Young et al. 2011).

Is there a faster test that could be used in labor?

It’s possible that a rapid-test for GBS during labor may be a better option for some women. In the same study mentioned above, researchers compared the 35-36 week culture test and the in-labor rapid test to the gold-standard test (culture during labor).

The researchers found that the 35-36 week culture test only identified 69% of the women who actually had GBS during labor. Meanwhile, the in-labor rapid test was much more sensitive—it identified 91% of women with GBS during labor (Young et al, 2011).

In a 2012 study in France, researchers followed a hospital as it switched from prenatal testing to in-labor testing for GBS. With the in-labor rapid GBS test, more mothers with GBS were identified (17% vs. 12%), there were fewer cases of early GBS infection in newborns (0.5% vs. 0.9%), and the financial cost was the same (El Helali et al. 2012).

One drawback of rapid-testing is that it can still take up to 60 minutes to get the results back, and women would have to wait to get antibiotics until the results came in (Honest et al. 2006; Young et al. 2011). The CDC says that the ideal rapid test for GBS could be done at the bedside in less than 30 minutes (CDC, 2010).

Right now there is one rapid GBS test on the market that claims it can be done within 30 minutes. However, a researcher who used this test in a clinical study says that this same test actually takes 50 minutes to carry out—5 minutes to prepare the sample, and 45 minutes to run the results (Personal communication, M. Hacker, April 2013). The price of this test is not listed online– so we don’t know if it’s affordable. Finally, researchers have not done studies yet to find out whether the rapid test is cost-effective.

What is the evidence for antibiotics during labor to prevent early GBS infection?

To answer this question, I will walk you through the most important studies that led to how we most commonly try to prevent early GBS infections in the U.S. today.

GBS emerged as a widespread threat to newborns in the early 1970’s. At that time, 1.7 of every 1,000 infants had early GBS infection (CDC 2010). In 1973, a researcher proposed giving pregnant women penicillin to stop early GBS infections in infants (Franciosi et al. 1973).

First, researchers tried giving penicillin to women before labor, but this didn’t work. Although penicillin temporarily lowered GBS levels, by the time women went into labor the GBS levels were back up again (Gardner et al. 1979).

Abbi laboring in the hospital with antibiotics for GBS.

Abbi laboring in the hospital with antibiotics for GBS.

Next, researchers tried giving antibiotics to women with GBS during labor. In the late 1980’s, three groups of researchers in the U.S., Spain, and Finland randomly assigned women with GBS to either receive IV antibiotics during labor (penicillin or ampicillin) or no antibiotics (Boyer & Gotoff 1985; Tuppurainen and Hallman 1989; Matorras et al. 1991).

In a recent Cochrane review, researchers combined the results of these 3 studies that had a total of 500 pregnant women. They found that when women with GBS had antibiotics during labor, their infants risk of catching early GBS infection dropped by 83% (Ohlsson & Shah 2013).

As the Cochrane reviewers noted, there were quite a few limitations to these 3 studies. In their summary, the reviewers said “There is no valid information from these three small, old, and biased trials to inform clinical practice.” However, this statement is biased. A more appropriate conclusion would be that there is some valid information from these studies, along with some limitations to the evidence.

Based on information from these 3 studies, in 1996, the CDC recommended 2 ways to prevent early GBS infections:

  1. The “universal approach.” Screen all pregnant women at 35-37 weeks and treat everyone who is positive with antibiotics during labor (this is the method that is currently used in the U.S.)
  2. The“risk-based approach.” Treat laboring women with antibiotics if they have one or more of these risk factors: GBS in the urine at any point in pregnancy, previously gave birth to an infant with early GBS infection, goes into labor at less than 37 weeks, has a fever during labor, or water has been broken for more than 18 hours (this is the method that is currently used in the United Kingdom)
Traci, who was GBS positive, labored without antibiotics in a hospital.

Traci, who was GBS positive, labored without antibiotics in a hospital.

In 2002, the CDC revised their guidelines to recommend the universal approach. This decision was based on an important study published in the New England Journal of Medicine (Schrag et al. 2002). In this study, researchers used CDC lab results and chart reviews to look at 629,912 live births that took place in the U.S. between the years 1998-1999.The researchers randomly selected 5,144 of these births to study, plus all 314 infants who were born with early GBS. They used hospital records to label women as receiving the universal approach (52%) or the risk-based approach (48%).

The results? There were 0.5 infants born with GBS per every 1,000 women.  Women in both groups received antibiotics about a third of the time. But women whose care providers used the universal approach had a 54% reduction in the risk of early GBS infection compared to women whose care providers used the risk-based approach. This means that the universal approach worked better than the risk-based approach.

In 2002-2003, the same group of researchers looked at 819,528 births in the U.S. to see whether the revised guidelines had been put into practice. Like the previous study, the researchers picked a random sample of women and infants to analyze, along with the 254 infants who had early GBS infection. Between 1999 and 2002, use of the universal approach rose from about 50% to 85%, and use of antibiotics during labor rose from 27% to 32%.

This time around, there were 0.32 infants born with early GBS per every 1,000 women (down from 0.5 cases per 1,000 only four years earlier). When researchers looked at the infants born at 37 weeks or later who had early GBS, only 18.0% were born to women who were not screened. Most of the cases of GBS in term infants (61%) happened in women who had been screened but tested negative for GBS. The researchers concluded that universal screening and antibiotic use cannot be expected to prevent 100% of early GBS infections, and that if we want to further lower GBS infection rates, then we will need access to rapid testing and vaccines against GBS (Van Dyke et al. 2009).

What is the best time to receive antibiotics for GBS?

Amy and her 3rd son. Amy was GBS positive but did not have antibiotics-- her son was born 27 minutes after her first real contraction!

Amy and her 3rd son. Amy was GBS positive but did not have antibiotics– her son was born 27 minutes after her first real contraction!

The CDC recommends that antibiotics be given every 4 hours, starting more than 4 hours before birth. Recent evidence supports these recommendations. In 2013, researchers looked at 7,691 live births that took place during 2003-2004 in the U.S. (randomly selected out of >600,000 births), along with 254 infants who had early GBS infection (Fairlie et al., 2013). About 1 in 3 women had antibiotics during labor (31%), and 59% of women received antibiotics more than 4 hours before birth.

When penicillin or ampicillin was given more than 4 hours before birth, it was effective 89% of the time. In contrast, giving antibiotics 2-4 hours before birth was effective 38% of the time. Antibiotics given less than 2 hours before birth were effective 47% of the time. When Clindamycin (another antibiotic) was used in place of penicillin, it worked very poorly (only 22% effective). There was no statistical difference between the 2-4 hour window and the 2-0 hour window, so even though the percentages look different, they are not statistically significant.

What are the potential benefits and harms of the universal screening and treatment approach?

Potential Benefits:

  • In clinical trials, using antibiotics (penicillin or ampicillin) decreases the risk of early GBS infection by 83%, although there are limitations to the quality of this evidence (Ohlsson 2013)
  • Penicillin rapidly crosses the placenta into the fetal circulation (at non-toxic levels) and can prevent GBS from growing in the fetus or newborn (CDC 2010; Barber et al. 2008).
  • In large studies in the U.S., the universal approach (screening and treating all GBS-positive women with antibiotics during labor) is associated with lower rates of GBS infections than giving antibiotics based on risk factors alone (Schrag et al. 2002).
  • Antibiotic resistance has not been a problem with penicillin, the drug most commonly used to prevent early GBS infection (CDC 2010).

Potential harms:

  • Although rare, severe allergic reactions in mothers have been reported. The risk is estimated to be 1 in 10,000 for a severe reaction, and 1 in 100,000 for a fatal reaction. (Weiss and Adkinson 1988).
    Jen had a successful VBAC after laboring with antibiotics for Group B Strep.

    Jen had a successful VBAC after laboring with antibiotics for Group B Strep.

  • There is an increase in the risk of maternal and newborn yeast infections. In one study, 15% of women who received antibiotics in labor had mother-baby yeast infections, compared to 7% of mothers who did not have antibiotics.  (Dinsmoor et al. 2005). 
  • Other potential harms have to do with side effects related to the antibiotic that is used (click on the link to see a comprehensive list of potential side effects for each antibiotic, but keep in mind that most of the serious risks are rare): Penicillin, ampicillin, cefazolin, clindaymycin, and vancomycin.
  • The potential medicalization of labor and birth (RCOG 2003).

What are the best antibiotics for someone who is allergic to penicillin?

Many women who have an allergy to penicllin can take Cefazolin instead. One advantage to Cefazolin is that (like penicillin) it crosses the placenta and reaches the fetus’s bloodstream. If a woman is at high risk for anaphylaxis with penicillin (click here to find out more), then the CDC recommends several different antibiotics instead of Cefazolin. Which antibiotic a woman can take depends on the results of her GBS lab tests. Alternative antibiotics include clindaymycin and vancomycin.

Bridget and her 11 pound son shortly after birth. Bridget was GBS positive and had 2 doses of antibiotics through a heplock. In between doses she was unhooked from the IV pole.

Bridget and her 11 pound son shortly after birth. Bridget was GBS positive and had 2 doses of antibiotics through a heplock. In between doses she was unhooked from the IV pole.

Unfortunately, clindamycin and vancomycin have never been tested in clinical trials for the prevention of early GBS infectionClindamycin faces high rates of drug resistance, barely reaches the fetal bloodstream, and should never be used unless a woman’s GBS has been specifically tested and it is known that these antibiotics will work on her particular strain of GBS. Vancomycin can be used in someone who is highly allergic to penicillin and whose GBS is resistant to clindamycin. However, Vancomycin barely crosses the placenta to get into the fetal circulation. Finally, although some care providers may use erythromycin to prevent early GBS, the CDC states that erythromycin should never be used to prevent early GBS infection (CDC, 2010; Pacifici 2006).

If I have antibiotics, does this mean I will be continuously hooked up to an IV?

No. If you use the antibiotics, you will have an IV placed, but it only takes 15-30 minutes for the antibiotics to run in.  The antibiotics are only given every 4 hours until birth, which for many women is only once or twice. When the IV is running, it should not limit positioning, walking, or even laboring in water. For the hours in between, the IV can be “hep-locked” or “saline-locked” and detached, so that you are free from the IV pole. For more information about saline locks, please read my article about saline locks during labor here.

Are there any other options?

One alternative to the universal approach is the “risk-based approach.” This is when you receive antibiotics based on other risk factors such as having a fever or your water being broken for more than 18 hours. This alternative is no longer recommended by the CDC. The number of women who receive antibiotics is roughly the same whether you choose the universal approach or the risk-based approach—about 30%. However, as already mentioned, evidence from large multi-state studies shows that in the U.S., the universal approach is more effective than giving antibiotics based on risk factors alone.

Chlorhexadine (aka Hibiclens) is a topical disinfectant that kills bacteria on contact. It binds easily to the skin and mucous membranes. In the vagina, the anti-GBS effects of chlorhexadine last from 3-6 hours.  Chlorhexadine has been shown to be safe, is easy to administer, and only costs a few cents per use (Goldenberg et al. 2006).

However, although chlorhexadine reduces the risk of a newborn being colonized with GBS, it has not been shown to decrease the risk of actual GBS infections in newborns. As I said earlier in the article, there is a difference between being colonized and being infected. Colonized babies almost always stay healthy, while infected babies are very sick, and it is thought that an actual early GBS infection occurs when the fetus swallows infected amniotic fluid into the lungs. In a Cochrane review (Stade et al. 2004), researchers combined results from 5 randomized, controlled trials that compared vaginal chlorhexadine to a placebo on outcomes of 2,190 infants born to women who were GBS positive. There was a wide range in the quality of the studies, with only one study being very high quality.

 

Lisa chose to use a hibiclens wash. She used it nightly for the last few weeks of pregnancy. During labor she washed after using the restroom and every 4 hours.

Lisa chose to use a hibiclens wash. She used it nightly for the last few weeks of pregnancy. During labor she washed after using the restroom and every 4 hours.

Even though women who used vaginal chlorhexadine reduced their infants’ risk of being colonized with GBS by 28%, there was no difference in rates of early GBS infection between women who used the chlorhexadine and those who did not. There were no cases of infant deaths from GBS in either group. The only adverse effects that were reported were stinging and irritation. The researchers called for a large clinical trial to test chlorhexadine for the prevention of early GBS.

Chlorhexadine may potentially be beneficial for women living in poor countries where access to antibiotics is limited. In their review of the literature, Goldenberg et al. (2006) found 2 studies from developing countries (Egypt and Malawi) where researchers tested chlorhexadine in the vagina  every 4 hours during labor and neonatal wipes shortly after birth. This is a lower level of evidence than the studies listed above, because neither of these were randomized, controlled trials. Instead, the researchers followed hospitals over a period of months when: 1) they did not use chlorhexadine, 2) they used chlorhexadine, and 3) they stopped using chlorhexadine. In both studies, researchers found that when chlorhexadine was used, there were immediate drops in newborn hospital admissions, newborn sepsis admissions, and newborn deaths due to infections. Unfortunately, researchers did not specifically count the number of GBS infections, just the overall number of babies who had admissions for sepsis.

So is chlorhexadine effective? The bottom line is that we don’t know with any certainty if it helps or not. Randomized, controlled trials show that in developed countries, chlorhexadine wipes during labor do not make any difference in early GBS infection rates. However, evidence from developing countries shows that chlorhexadine vaginal wipes PLUS newborn wipes may reduce sepsis rates in general. Chlorhexidine is likely better than nothing, but it cannot prevent the ascent of GBS in the amniotic fluid unless it is given before a woman’s water breaks and repeated before its effect wears off. Unlike IV antibiotics, there is no evidence that chlorhexadine can stop GBS from growing in the fetus before birth.

Garlic has antibacterial properties, and some websites recommend putting garlic in the vagina to eliminate GBS before the GBS test. However, there is very little evidence to back up this treatment. One group of researchers put garlic extract and GBS in a petri dish together (Cutler et al., 2009). They found that the garlic was able to kill the GBS within about 3 hours. However, this treatment has never been tested in people. Also, it’s important to understand that back in the 1970’s when researchers tried using penicillin during pregnancy, they found that the antibacterials temporarily lower levels of GBS, but levels almost always go up again by the time women go into labor. So by temporarily using garlic, this could help you get a negative test result, but the effect will wear off very quickly. 

Some women choose to keep garlic or chlorhexidine in the vagina for the last 4 weeks of pregnancy or use either of these treatments regularly before their water breaks and before they go into labor. It’s possible that this may help decrease GBS levels before labor. However, we do not have any research evidence yet to support this practice. This means we have little evidence about the potential benefits and harms. For example, it is possible that long-term garlic or chlorhexidine use could potentially or theoretically  have unexpected effects like premature rupture of membranes or increase other bacteria– even GBS– due to destruction of good bacteria, like lactobacilli. Until researchers examine the potential benefits and harms, there are a lot of unknowns related to this treatment.

Vaccines for GBS are under development, but are not available yet at this time (World Health Organization, 2005). There is a big push for a GBS vaccine for several reasons: 1) in-labor antibiotics do not prevent GBS infection 100% of the time (Velaphi et al., 2003), 2) in-labor antibiotics can have side effects, and 3) in-labor antibiotics do not prevent other GBS problems, such as preterm labor.

Taking probiotics (lactobacilli) is another remedy that people sometimes use to eliminate GBS in the vagina. In several studies, researchers have put vaginal lactobacilli (including a commercially available version) in a petri dish with different strains of GBS. They found that the lactobacilli strongly inhibited the growth of GBS by increasing the acidity of the environment. (Acikgov, 2005– article in Turkish; Zarate, 2006).

In a small clinical trial, researchers randomly assigned healthy, fertile (but non-pregnant) women to wear panty liners that were saturated with probiotics, or to wear placebo panty liners. The results showed that it is possible to transfer probiotics to the vagina using panty liners. The researchers also found that women who had higher levels of lactobacilli in the vagina had lower levels of GBS. However, although these results are promising, large clinical trials need to be conducted in pregnant women to determine if this is an effective way to prevent early GBS infection in newborns (Rönnqvist PD, 2007).

A few websites mention colloidal silver as a remedy for preventing GBS infection. Although silver has anti-bacterial properties, no known research studies have ever been conducted on taking colloidal silver to prevent a GBS infection—and no studies have ever looked at the safety of colloidal silver in pregnancy. The potential benefits and harms of this substance are unknown. In 1997, the FDA stated that colloidal silver is not safe or effective for any condition.

Can infants acquire a GBS infection from staff handling the newborn?

Barbara decided not to have antibiotics for GBS. Her daughter was born at home.

Barbara decided not to have antibiotics for GBS. Her daughter was born at home.

Researchers are quite certain that infants catch early GBS infections before they are born—most likely from GBS in the amniotic fluid. As mentioned earlier, almost all infants with early GBS infection show symptoms within an hour after birth. However, infants can catch “later” GBS infections from the hospital (nursery, hands of hospital staff and family members) or the community. This is one reason hand-washing is so important (Kliegman et al. 2011).

If I am GBS positive, and I don’t get the IV antibiotics for some reason, what kind of tests will my baby need to have?

As long as your baby appears to be doing well and you did not have any additional risk factors (<37 weeks, infection of the uterus, water broken >18 hours), then there is no need for your baby to have any special testing. There are some situations where the CDC recommends that a well-appearing infant have some blood tests. The CDC also  recommends 48 hours of “observation”for infants who are born to GBS positive mothers, but there is no need to separate mom and baby for this observation period. To see a flow-chart with more details about newborn testing and observation, click here.

What do national organizations have to say?

In the United States:

The U.S. Centers for Disease Control and Prevention recommends universal screening for GBS at 35-37 weeks and in-labor antibiotics for all women who test positive.

Kimberly laboring with antibiotics for GBS

  • American Congress of Obstetricians and Gynecologists
  • American Academy of Pediatrics
  • American College of Nurse-Midwives
  • American Academy of Family Physicians
  • American Society for Microbiology

In the United Kingdom:

  • The United Kingdom National Screening Committee states that pregnant women in the UK should not be screened for GBS. The UK follows the risk-based approach. This includes giving antibiotics in-labor to all women who have fever, prolonged rupture of membranes >18 hours, GBS in urine at any time during pregnancy, preterm labor, or a prior infant with GBS. This means that many women who are actually GBS negative receive antibiotics directed at GBS, just based on their risk factors.  In the UK, the rate of early GBS infections is 0.5 per 1,000 births, which is slightly higher than the rate of 0.2 per 1,000 births in the U.S. In the UK, it is not considered cost effective to screen the whole population of pregnant women to lower the early GBS infection rate by 0.2-0.3 cases per 1,000.
  • The Royal College of Obstetricians does not recommend routine screening for GBS during pregnancy. However, they do state that in-labor antibiotics could be considered if GBS was detected in passing or if women have any of the risk factors listed above. Many women are already receiving antibiotics for these reasons.
  • There is controversy in the UK over the lack of access to GBS testing within the National Health Service. Group B Strep Support is a consumer-based charity that advocates for women to have access to GBS screening in the UK.

In Canada:

What is the bottom line?

  • Since two-thirds of remaining early GBS infections are now due to false negative GBS test results, in the future we may benefit from a rapid in-labor test for GBS
  • While probiotics, chlorhexadine, and garlic have the potential to reduce vaginal and newborn colonization with GBS, we do not have evidence yet to show that these strategies can prevent early GBS infections, since GBS infection usually occurs when GBS gains access to the amniotic fluid and gets into the fetus’ lungs during labor.

 

Ashley's baby, a survivor of GBS, healthy at 6 months old.

Ashley’s baby, a survivor of GBS, healthy at 6 months old.

I would like to acknowledge my reviewers for helping maintain the quality of articles published at Evidence Based Birth. In particular, I would like to acknowledge Dr. Jessica Illuzzi, Associate Professor of Obstetrics, Gynecology, and Reproductive Sciences at Yale School of Medicine, for her expert review and assistance in writing this article. I would also like to acknowledge my 2 regular physician reviewers, and 2 other anonymous peer reviewers (a GBS rsearcher and a microbiologist).

This blog article will be open to public comments for 2 weeks, starting Tuesday, April 9. After this period of open commenting is over, I will take peoples’ comments into consideration and make additions or revisions to the article.

Did you like this article?

Follow Evidence Based Birth:

Facebook: www.facebook.com/evidencebasedbirth 

Twitter: www.twitter.com/birthevidence 

Pinterest: www.pinterest.com/birthevidence

You may also want to read:

The Evidence for Skin-to-Skin Care after a Cesarean

The Evidence for Erythromycin Ointment in Newborns

References

  1. Adair, C. E., L. Kowalsky, et al. (2003). “Risk factors for early-onset group B streptococcal disease in neonates: a population-based case-control study.” CMAJ 169(3): 198-203. Click here.
  2. Ackigov, Z. C., S. Gamberzade et al. (2005). “Inhibitor effect of vaginal lactobacilli on group B streptococci.” Mikrobiyol Bul 39(1): 17-23. (Article in Turkish and unable to translate). Click here.
  3. Barber, E. L., G. Zhao, et al. (2008). “Duration of intrapartum prophylaxis and concentration of penicillin G in fetal serum at delivery.” Obstetrics and gynecology 112(2 Pt 1): 265-270. Click here.
  4. Boyer, K. M. and S. P. Gotoff (1985). “Strategies for chemoprophylaxis of GBS early-onset infections.” Antibiot Chemother 35: 267-280. Click here.
  5. Centers for Disease Control and Prevention (CDC) (2009). “Trends in perinatal group B streptococcal disease- United States, 2000-2006.” MMWR Morb Mortal Wkly Rep 58: 109-112.
  6. CDC (2010). “Prevention of perinatal group b streptococcal disease.” MMWR 59: 1-32. Click here.
  7. CDC (2012). “ABCs report: Group B streptococcus, 2010.”   Retrieved March 10, 2013. Click here.
  8. CDC (1996). “Prevention of perinatal group B streptococcal disease: a public health perspective. .” MMWR Recomm Rep 45: 1-24.
  9. CDC (2005). “Early-onset and late-onset neonatal group B streptococcal disease– United States, 1996-2004.” MMWR Morb Mortal Wkly Rep 54: 1205-1208.
  10. Cutler, R. R., Odent M, et al. (2009). In vitro activity of an aqueous allicin extract and a novel allicin topical gel formulation against Lancefield group B streptococci. J Antimicrob Chemother 63(1): 151-154. Click here.
  11. Dinsmoor, M. J., R. Viloria, et al. (2005). “Use of intrapartum antibiotics and the incidence of postnatal maternal and neonatal yeast infections.” Obstetrics and gynecology 106(1): 19-22. Click here.
  12. El Helali, N., Y. Giovangrandi, et al. (2012). “Cost and effectiveness of intrapartum group B streptococcus polymerase chain reaction screening for term deliveries.” Obstetrics and gynecology 119(4): 822-829. Click here.
  13. Fairlie, T., E. R. Zell, et al. (2013). “Effectiveness of intrapartum antibiotic prophylaxis for prevention of early-onset group b streptococcal disease.” Obstetrics and gynecology 121(3): 570-577. Click here.
  14. Feigin, R. D., J. D. Cherry, et al. (2009). Textbook of Pediatric Infectious Diseases, Saunders.
  15. Franciosi, R. A., J. D. Knostman, et al. (1973). “Group B streptococcal neonatal and infant infections.” J Pediatr 82(4): 707-718. Click here.
  16. Gardner, S. E., M. D. Yow, et al. (1979). “Failure of penicillin to eradicate group B streptococcal colonization in the pregnant woman. A couple study.” Am J Obstet Gynecol 135(8): 1062-1065. Click here.
  17. Goldenberg, R. L., E. M. McClure, et al. (2006). “Use of vaginally administered chlorhexidine during labor to improve pregnancy outcomes.” Obstetrics and gynecology 107(5): 1139-1146. Click here.
  18. Heath, P. T., G. F. Balfour, et al. (2009). “Group B streptococcal disease in infants: a case control study.” Arch Dis Child 94(9): 674-680. Click here.
  19. Honest, H., S. Sharma, et al. (2006). “Rapid tests for group B Streptococcus colonization in laboring women: a systematic review.” Pediatrics 117(4): 1055-1066. Click here.
  20. Johri, A. K., L. C. Paoletti, et al. (2006). “Group B Streptococcus: global incidence and vaccine development.” Nat Rev Microbiol 4(12): 932-942. Click here.
  21. Kliegman, R. M., B. F. Stanton, et al. (2011). Nelson Textbook of Pediatrics, Saunders.
  22. Libster, R., K. M. Edwards, et al. (2012). “Long-term outcomes of group B streptococcal meningitis.” Pediatrics 130(1): e8-15. Click here.
  23. Mandell, G. L., J. E. Bennett, et al. (2010). Principles and practice of infectious diseases, Elsevier.
  24. Matorras, R., A. Garcia-Perea, et al. (1991). “Maternal colonization by group B streptococci and puerperal infection; analysis of intrapartum chemoprophylaxis.” Eur J Obstet Gynecol Reprod Biol 38(3): 203-207. Click here.
  25. Ohlsson, A. and V. S. Shah (2013). “Intrapartum antibiotics for known maternal Group B streptococcal colonization.” Cochrane Database Syst Rev 1: CD007467. Click here.
  26. Ronnqvist, P.D., U. B. Forsgren-Brusk, et al. (2006). “Lactobacilli in the female genital tract in relation to other genital microbes and vaginal pH.” Acta Obstet Gynecol Scand 85(6): 726-735. Click here.
  27. Schrag, S. J., E. R. Zell, et al. (2002). “A population-based comparison of strategies to prevent early-onset group B streptococcal disease in neonates.” N Engl J Med 347(4): 233-239. Click here.
  28. Stade, B., V. Shah, et al. (2004). “Vaginal chlorhexidine during labour to prevent early-onset neonatal group B streptococcal infection.” Cochrane Database Syst Rev(3): CD003520. Click here.
  29. Tudela, C. M., R. D. Stewart, et al. (2012). “Intrapartum evidence of early-onset group B streptococcus.” Obstetrics and gynecology 119(3): 626-629. Click here.
  30. Tuppurainen, N. and M. Hallman (1989). “Prevention of neonatal group B streptococcal disease: intrapartum detection and chemoprophylaxis of heavily colonized parturients.” Obstetrics and gynecology 73(4): 583-587. Click here.
  31. Valkenburg-van den Berg, A. W., A. J. Sprij, et al. (2009). “Association between colonization with Group B Streptococcus and preterm delivery: a systematic review.” Acta obstetricia et gynecologica Scandinavica 88(9): 958-967. Click here.
  32. Van Dyke, M. K., C. R. Phares, et al. (2009). “Evaluation of universal antenatal screening for group B streptococcus.” N Engl J Med 360(25): 2626-2636. Click here.
  33. Velaphi, S., J. D. Siegel, et al. (2003). “Early-onset group B streptococcal infection after a combined maternal and neonatal group B streptococcal chemoprophylaxis strategy.” Pediatrics 111(3): 541-547. Click here.
  34. Weiss, M. E. and N. F. Adkinson (1988). “Immediate hypersensitivity reactions to penicillin and related antibiotics.” Clin Allergy 18(6): 515-540. Click here.
  35. WHO. State of the art of vaccine research and development: Initiative for Vaccine Research. 2005. [online] http://www.who.int/vaccine_research/documents/Dip%20814.pdf.
  36. Young, B. C., L. E. Dodge, et al. (2011). “Evaluation of a rapid, real-time intrapartum group B streptococcus assay.” Am J Obstet Gynecol 205(4): 372 e371-376. Click here.
  37. Zarate, G. & Nader-Macias, M. E. (2006). “Influence of probiotic vaginal lactobacilli on in vitro adhesion of urogenital pathogens to vaginal epithelial cells.” Lett appl Microbiol 43(2): 174-178. Click here.

Posted in: Evidence based practice, Tests during pregnancy

Leave a Comment: (46) →

The Evidence for Doulas

The Evidence for Doulas

© 2013 by Rebecca L. Dekker, PhD, RN, APRN of www.evidencebasedbirth.com

This is an updated version of an article that was originally published in June 2012. In addition to updating this article, I partnered with Doulaville Seattle and ImprovingBirth.org to create a handout version of this article called: “Doulas and HealthCare Providers: Working Together for Better Maternal and Infant Outcomes.” To download the free handout, click on the link and it will take you to a Google document. Feel free to print  the handout and link to it on your websites. Thank you to Jenne of Doulaville for taking the lead and creating this handout for others to use!

Follow Evidence Based Birth on Facebook or subscribe to the blog (upper right hand corner of the website) to receive updates about future articles!

Photo submitted by Rebekah of Great Expectations.

Photo submitted by Rebekah of Great Expectations.

What is a doula?

According to DONA International, a doula is a professional who is trained in childbirth and provides continuous support to a mother before, during, and just after birth (postpartum douluas are not covered in this article). Doula comes from a Greek word that means “a woman who serves” or “handmaiden.”

How many women use doulas?

In a 2006 survey that took place in the U.S., only 3% of women said they used a doula during childbirth (Declerq et al., 2007).

What do doulas do?

Doulas “mother the mother.” While performing her role, a doula:

  • Provides emotional support
  • Uses comfort measures: breathing, relaxation, movement, positioning
  • Gives information
  • Continuously reassures and comforts the mother (the key word is continuous—a doula never leaves the mother’s side)
  • Helps a mother become informed about various birth choices
  • Advocates for the mother and helps facilitate communication between the mother and care provider
  • Looks after your partner as well (gives them bathroom breaks!), but their primary responsibility is to the mother
Katja says: "My husband was deployed but present via Skype for the whole thing. Thanks to my doula I was still able to have my homebirth. My daughter is a little doula-to-be."

Katja says: “My husband was deployed but present via Skype for the whole thing. Thanks to my doula I was still able to have my homebirth. My daughter is a little doula-to-be.”

It’s also important for you to understand what doulas do NOT do:

  • Doulas are NOT medical professionals
  • They do not perform clinical tasks such as vaginal exams or fetal heart monitoring
  • They do not give medical advice or diagnose conditions
  • They do not judge you for decisions that you make
  • They do not let their personal values or biases get in the way of caring for you (for example, they should not pressure you into making any decisions just because that’s what they prefer)
  • They do not take over the role of your husband or partner
  • They do not deliver the baby
  • They do not change shifts

You can read more about what doulas do and do not do in the DONA International’s standard of practice for birth doulas written here.

A doula does not leave your side and does not change shifts. Credit: Great Expectations

A doula does not leave your side and does not change shifts. Credit: Great Expectations

How is a doula different from a labor and delivery nurse or partner/spouse?

The most important thing a woman needs during labor is continuous support. This means that you have someone by your side continuously from start to finish. A doula never leaves your side. Nurses have many other responsibilities other than you. Aside from helping care for you, the nurse is communicating with your care provider, taking care of other patients, documenting care, taking breaks, and taking care of other responsibilities. A nurse’s support ends when her shift does. The doula only has one obligation the whole time she is with you—and that is YOU!

Dads and doulas can work together to make a support team for the mother. Credit: Great Expectations

Dads and doulas can work together to make a support team for the mother. Credit: Great Expectations

Sometimes people think that they don’t need a doula because their partner will be with them continuously throughout labor. Your partner is an essential support person for you to have by your side. However, your partner will need to eat and use the bathroom at times. Also, most partners have limited knowledge about birth, medical procedures, or what goes on in a hospital. Doulas and partners can work together to make up a labor support team. To read a husband’s perspective on hiring a doula, read this article from Bloom in Spokane, Washington.

 

So what is the evidence for doulas?

In 2012, Hodnett et al. published an updated Cochrane review on the use of continuous support for women during childbirth. They pooled the results of 22 trials that included more than 15,000 women. These women were randomized to either receive continuous, one-on-one support during labor or “usual care.” The quality of the studies was good.

"Here is a photo of me working with a wonderful mom in labor and her AMAZING partner. Any pregnant woman would be lucky to have a birth partner like him!" Credit: Samantha of Lavender Labor

“Here is a photo of me working with a wonderful mom in labor and her AMAZING partner. Any pregnant woman would be lucky to have a birth partner like him!” Credit: Samantha of Lavender Labor

Continuous support was provided either by a member of the hospital staff, such as a midwife or nurse (9 studies), women who were not part of the woman’s social network and not part of

hospital staff (doula 5 studies; childbirth educators 1 study, retired nurses 1 study), or a companion of the woman’s social network such as a female relative or the woman’s partner (6 studies). In 11 studies, the husband/partner was not allowed to be present at birth, and so continuous support was compared to no support at all. In all the other studies, the husband or partner was allowed to be present in addition to the person providing continuous labor support.

Dawn and her doula, Kate.

Dawn and her doula, Kate.

Overall, women who received continuous support were more likely to have spontaneous vaginal births and less likely to have any pain medication, epidurals, negative feelings about childbirth, vacuum or forceps-assisted births, and C-sections. In addition, their labors were shorter by about 40 minutes and their babies were less likely to have low Apgar scores at birth.

What does this mean?

It means that if you have continuous labor support (that is, someone who never leaves your side), you are statistically more likely to have better outcomes and your baby is more likely to have better outcomes! How did doulas compare to the other types of continuous support?

The researchers also looked to see if the type of support made a difference. They wanted to know—does it matter who you choose for your continuous support? Does it matter if you choose a midwife, doula, or partner for your continuous support? They were able to look at this question for 6 outcomes: use of any pain medication, use of Pitocin during labor, spontaneous vaginal birth, C-section, admission to special care nursery after birth, and negative ratings of birth experience.

Brinda with her doula and birth partner

Brinda with her doula and birth partner

For most of these outcomes,* the best results occurred when woman had continuous labor support from a doula– someone who was NOT a staff member at the hospital and who was NOT part of the woman’s social network. When continuous labor support was provided by a doula, women experienced a:

  •  
    A doula with her client

    31% decrease in the use of Pitocin*

  • 28% decrease in the risk of C-section*
  • 12% increase in the likelihood of a spontaneous vaginal birth*
  • 9% decrease in the use of any medications for pain relief
  • 14% decrease in the risk of newborns being admitted to a special care nursery
  • 34% decrease in the risk of being dissatisfied with the birth experience*

For four of these outcomes,* results with a doula were better than all the other types of continuous support that were studied. For the other outcomes, there was no difference between types of continuous support.

Why are doulas so effective?

A doula can act as a buffer in a harsh environment

A doula can act as a buffer in a harsh environment

There are 3 main reasons why we think doulas are so effective. The first reason is the “harsh environment” theory. In most developed countries, ever since birth moved out of the home and into the hospital, women have been giving birth in conditions that can often be described as harsh. In the hospital, laboring women are frequently submitted to institutional routines, high intervention rates, personnel who are strangers, lack of privacy, bright lighting, and needles. Most of us would have a hard time dealing with these conditions when we’re feeling our best. But women in labor to deal with these harsh conditions when they are in their most vulnerable state. These harsh conditions may slow down a woman’s labor and decrease the woman’s self-confidence. It is thought that a doula “buffers” this harsh environment by providing continuous support and companionship which promotes the mother’s self-esteem (Hofmeyr, Nikodem et al. 1991).

doula_dawn2The second reason we think doulas are so effective is because of the specific interventions that they use. Doulas are skilled at encouraging mobility during labor—encouraging women to use gravity and helping women find comfortable positions for laboring and pushing. Doulas may also reduce fear and anxiety in laboring women. Fear and anxiety are harmful during labor because they initiate the “fight or flight” response, which can increase pain, slow down labor, and lead to abnormal heart rate patterns in baby. Doulas can decrease these harmful effects of fear and anxiety by giving emotional support, providing information and advice, and using comfort measures. (Hodnett 2002)

A dad says: "My experience has shown me that, whether you're giving birth in the hospital, birth center, or at home,  your impact and ability to connect and support your wife during the birth process is both supported and maximized by having a doula there on your team." Credit: www.yourbirthjourney.net and Seattle Birth Photography

A dad says: “My experience has shown me that, whether you’re giving birth in the hospital, birth center, or at home, your impact and ability to connect and support your wife during the birth process is both supported and maximized by having a doula there on your team.” Credit: www.yourbirthjourney.net and www.onetreephotography.com

The third reason that doulas are effective is because doulas are a form of pain relief (Hofmeyr, 1991). With continuous support, women are less likely to request epidurals or pain medication (Hodnett, 2011). Why are women with doulas less likely to request pain medications? Well, women are less likely to request pain medications when they have a doula because they just don’t need an epidural as much! Women who have a doula are statistically more likely to feel less pain when a doula is present. Furthermore, by avoiding epidural anesthesia, women may avoid many medical interventions that often go along with an epidural, including Pitocin augmentation and continuous electronic fetal monitoring (Caton, Corry et al. 2002).

Based on reading the evidence, I have come up with a conceptual model of how doulas support influences outcomes.

A conceptual model is what researchers use to try and understand how a phenomenon works. Here is my conceptual model on the phenomenon of doula support. This model has already been translated into several different languages– please contact me if you would like to translate it into your native language.

How do I find a doula?

If you’re at all on the fence about hiring a doula, you may want to interview several doulas with your partner. Childbirth Connection has a great list of interview questions for a doula. They also have a list of websites that you can use to find doulas in your area.

So what is the bottom line?

Evidence shows that the most important thing is for women to have continuous labor support from someone– whether that person is a nurse, midwife, partner, or doula. However, with several birth outcomes, doulas have a stronger effect than other types of support persons.

Download the free printable handout called “Doulas and Health Care Providers: Working Together for Better Maternal and Infant Outcomes.”

You may also want to read:

 The Evidence for Skin-to-Skin Care after a Cesarean

The Evidence for Erythromycin Ointment in Newborns

A Doula helps Change Law about Erythromycin Ointment

A Doula Facilitates Skin-to-Skin in the Operating Room

 

 

Credit: Heidi of www.yourbirthjourney.net and Seattle Birth Photography

Credit: Heidi of www.yourbirthjourney.net and Seattle Birth Photography

References:

  1. Caton, D., M. P. Corry, et al. (2002). “The nature and management of labor pain: executive summary.” Am J Obstet Gynecol 186(5 Suppl Nature): S1-15.
  2. Declercq ER, Sakala C, Corry MP, Applebaum S. (2007). “Listening to mothers II: Report of the second national U.S. survey of women’s childbearing experiences.” The Journal of Perinatal Education 16:9-14.
  3. Hodnett, E. D. (2002). “Pain and women’s satisfaction with the experience of childbirth: a systematic review.” Am J Obstet Gynecol 186(5 Suppl Nature): S160-172.
  4. Hodnett, E. D., S. Gates, et al. (2012). “Continuous support for women during childbirth.” Cochrane database of systematic reviews: CD003766.
  5. Hofmeyr, G. J., V. C. Nikodem, et al. (1991). “Companionship to modify the clinical birth environment: effects on progress and perceptions of labour, and breastfeeding.” British journal of obstetrics and gynaecology 98(8): 756-764.

Posted in: C-section, Cochrane review, Doulas, Evidence based practice

Leave a Comment: (4) →

Diagnosing Gestational Diabetes: The NIH Consensus Conference Day 2

Diagnosing Gestational Diabetes: The NIH Consensus Conference Day 2

March 5, 2013

Today, I am blogging the results from the second day of the NIH Consensus Development Conference on Diagnosing Gestational Diabetes. The purpose of this conference is to come to a consensus on two things: the best way to diagnose gestational diabetes (GDM), and whether we should change the criteria we use to diagnose GDM in the U.S. To read the summary from the first day of the conference, click here.

As a side note, the information presented below is the summary of the researcher’s presentations, and do not necessarily represent my opinion or the opinion of Evidence Based Birth. I am merely summarizing the presentations for you. A special thank you to the Evidence Based Birth moms and babies who provided photos for this blog article.

____________________________________________________________________

Jen says, "I have GD." :)

Jen says, “I have GD.” :)

Review of Maternal Experience of Having Diabetes Mellitus in Pregnancy
Presented by Ilana R. Azulay Chertok, PhD, MSN, RN, IBCLC
Associate Professor
West Virginia University School of Nursing

Dr. Chertok presented a presentation called, “In their own Voices: Experience of Women with Gestational Diabetes

The purpose of her presentation is to describe the perspectives and feelings of women with GDM. Dr. Chertok conducted a review of the qualitative literature and found 10 studies that interviewed women to find out their perspectives on GDM. There was a wide variety of women who participated. Six of the studies took place in the US, and the other studies took place in Australia, Canada, and Sweden. The women were ethnically diverse and included immigrants and minority women.

How did women respond to the diagnosis? They were shocked, surprised, upset, depressed, disappointed, scared, and felt like they had failed (flunked).

The women had many different perceptions for the possible cause of the GD, including fate,  the will of God, the “evil eye,” lifestyle, stress, diet, weight, heredity, and family history.

What these women wanted was accurate information and guidance. But they didn’t get this. Most women felt that their providers were unable to guide them appropriately. Their providers lacked accurate information, didn’t have time to explain diagnosis, symptoms, and management, and were unavailable for answers and guidance. Providers frequently used “scare tactics” and “preached” to women to make them comply with recommendations.

Amelia and her 7 pound, 14 ounce "gestational diabetes" baby

Amelia and her 7 pound, 14 ounce “gestational diabetes” baby

Overall, women felt there was a lack of tailored care for GDM:

  • They were often told what they already knew, and often this information was presented in a condescending manner
  • Providers did not address the information women wanted to hear
  • Nutrition information that was given was not specific to culture
  • Many women from different cultures felt like they were kept in the dark– Latina women in particular felt they were not given information in a language that they could understand

Women were concerned about their infants. They experienced:

  • Constant worry and anxiety over their baby
  • Self-blame and guilt
  • More medicalization throughout the prenatal care and delivery
  • In the postpartum period, women felt added guilt when infant needed additional monitoring. They continued to feel conern about infant’s health and risk for Type 2 diabetes after birth, and they were very scared by hypoglycemia episodes in the infant

 

Cristine says, "Here is my GD baby at 10 months old. Little man and I never had any problems after birth and he was allowed to go straight to my chest and breastfeed. He was also a VBAC baby as I had a C-section with my non GD twins."

Cristine says, “Here is my GD baby at 10 months old. Little man and I never had any problems after birth and he was allowed to go straight to my chest and breastfeed. He was also a VBAC baby as I had a C-section with my non GD twins.”

Women were concerned about themselves:

  • It was difficult to make a sudden lifestyle change.
  • Women felt limited and restricted–”everything is so strict,” “you are not free,” “you have to follow rules,” “you can’t do this, you can’t do that.”
  • They faced barriers to managing GDM– not enough money, healthy food was more expensive, self-care discomfort (having to prick finger and give shots), lack of time for exercise, culturally inappropriate instructions, lack of support or understanding by others.
  • They worried about their future risk of diabetes– some women knew they were at increased risk, other women didn’t know, some got inaccurate information.
  • One silver lining– women saw this as a way to make positive change– to lose weight, eat healthier, and keep in shape. There IS a positive way to frame GDM.

 

Mindy and her baby.
Mindy and her baby

Importantly, women felt like they lost control:

  • Women were subjected to scrutiny and lectures by family and friends about behaviors– they felt judged about everything (food, activity, testing).
  • The healthcare providers usurped control. “I was constantly fighting toward the end… I really felt like they were taking all this control away from me…” “They know your body, even though it’s your body.”
  • Medical needs were often disregarded– for example, one woman requested an induction and it was denied her, then she needed a C-section; other women had to fight to get insulin prescribed.
  • Women felt a loss of internal control when they were unable to control blood sugar: “It was totally out of my control.”
  • They weren’t informed– “It would be nice to know the tests you are going to need without coercion and with time to consider options.”

 

Anna and her baby. Anna says, "The more support out there for GD mamas, the better!"

Anna and her baby. Anna says, “The more support out there for GD mamas, the better!”

Based on women’s experiences, Dr. Chervak recommends:

  • Use a multidisciplinary team and make the patient an integral part of the team
  • Avoid using scare tactics, frame information positively
  • Provide access to accurate, clear information about GDM
  • Point women to accurate GDM websites and online support/chat rooms
  • Use culturally appropriate language and information
  • Encourage support from family and friends, introduce women to role models (other women with GDM)
  • Discuss and write a birth plan

_______________________________________________________________________

Pro Status Quo
Presented by Brian M. Casey, MD
Gillette Professorship
Obstetrics and Gynecology
The University of Texas Southwestern Medical Center

In Dr. Casey’s opinion, GDM is really about the excessive fetal growth associated with high blood sugars. That was not the initial intent behind the original work on GDM, because back then, those researchers were most interested in predicting risk of women developing Type II diabetes later in life. However, later we “woke up” to the fact that there were more immediate consequences to GDM.

In 1979 we had the first international conference that identified GDM as an important risk factor that should be identified and treated. Since then, we’ve had multiple study groups and organizations grappling with how to make this diagnosis and how to deal with it. That leads us to today’s status quo.

What is the status quo today with GDM in the U.S.?

The status quo is a systematic 2-step approach to identify women who are at the highest risk for fetal overgrowth from maternal high blood sugars. If you look at 100 women in the U.S., 1 would have overt Type II diabetes, and 7 would be diagnosed with GDM.

So what’s the impetus for change?

Well, the HAPO study showed a continuous increase in risk for several outcomes with GDM, including birth weights and C-section. If we look at the exact relationship between the mother’s blood sugars and large for gestational age babies, you can see that the risk increases incrementally. But it’s not really until you get down to the highest blood sugars that you get to odds ratios above 3.  Dr. Casey quoted an article published recently by an epidemiologist, who wrote that in observational studies, odds ratios of 1 to 3 should make us skeptical that there is really an impact on outcomes.

Then the ACHOIS trial showed that women with GDM who received treatment had a significant reduction in a combined endpoint of serious outcomes, and a decrease in fetal growth. In addition, the MFMU trial showed that there was no difference between treatment and control with regard to serious outcomes, but there was a decrease in shoulder dystocia and C-sections (although the principal investigator from the MFMU trial said that he doesn’t think that a decrease in C-sections would happen in women who are treated for lower blood sugars).

So just now we finally have evidence to support what we’ve been doing all along.

But then the International Association of Diabetes and Pregnancy Study Groups (IADPSG) recommended a single-step test so that would universalize how we screen women for GDM. With this single 75 gram 2 hour test, women would only need one abnormal value for diagnosis, and there would be lower cut-offs than what have been typically used in the past.

So let’s look at these things. First, going from a 2-step process to a 1-step process:  If you give the 1-hour 50 gram test, the same patients who score positive coud re-take it, and their results would be normal about 1/3 of the time. So it’s not the most accurate test. The 3-hour 100 gram test is only reproducible about 75% of the time, meaning that the same patient would get the same results about 75% of the time. There is a lot of variability in single glucose tests, which is why it would be concerning to diagnose women based on only one value. This means that a patient with a fasting value could have a wide variety in what their results are on any given day.

If we talk about lower thresholds, the new recommendations are based on a 1.75 higher risk (odds ratio) for large infants. This means that they determined the new cut-off value for GDM because women at that glucose level had a 1.75 times higher risk of giving birth to a big baby. BUT, 70-80% of overgrown infants are born to women WITHOUT GDM. So Dr. Casey asked, is this the best way to make an impact on large babies? Another important point to keep in mind is that the ACHOIS and MFMU studies had higher average fasting blood sugars than women in the HAPO study. So we don’t really have clinical trial data to support lowering the cut-off.

Now with the new recommendations, it will increase the percentage of women with GDM from 6-7% to about 18%, which means 11 additional women per 100. We don’t have strong evidence to show that it will be beneficial to identify these additional 11 women. The women that we are already diagnosing are not at very higher risk, and so what good would it do to include these women who have glucose levels below that?

So what are potential harms? Well, we cannot underestimate the effect of “labeling” women with GDM. The label of GDM has a profound effect on how healthcare providers treat women. The ACHOIS trial had a significant increase in admissions to the neonatal nursery, probably because of the labeling effect, because care providers were overly concerned about the babies. The labeling of women with GDM changes the way physicians treat women.

Any other harms? In one study (Feig et al., 1998) among women who were diagnosed with GDM 3-5 years later, researchers found that women with GDM were more worried about their own health, rated their child’s health more poorly, and rated their general health as poorer. GDM even impacted whether or not women would pursue another pregnancy in the future.

Another study found that as you decrease blood sugars in women with GDM, you increase the workload. What are the resource implications of increasing this workload? Dr. Casey shared his own personal story. He is the medical director for a GDM clinic. Right now, he has 2 half-day clinics per week, andthey see 120-150 women with GDM per week. At his clinic, there are 8,000 clinic visits annually, and these visits are run by 8 nurses, 2 diabetes educators, 1 certified nutritionist, 10-12 APNS, 1 fellow, and 3 faculty. If we doubled or tripled the diagnosis, Dr. Casey said this would “crush us.” They couldn’t do as good a job as they are doing right now with these women who are at highest risk.

Furthermore, the cost of gestational diabetes in the U.S. would go from $636 million per year to $2 billion per year.

What are the criteria for change? These criteria must be met:

1. Women must be clearly at risk for important health outcomes associated with a positive test

  • This is supported by the HAPO study.
  • But, maternal weight gain and BMI are confounders

2. The diagnostic test should be reliable

  • We are going to rely strongly on a single result, which will lower the specificity of the test

3. There should be proof a treatment will prevent those outcomes

  • We do not have evidence to support this right now, using a lower cut-off.

4. The intervention should be cost-effective

  • There will be a significant increase in costs
  • Any cost-effective analyses assume that there will be positive outcomes
  • But right now, we have no data to tell us what the outcomes are going to be
  • Improvement in short-term outcomes for these lesser-risk women is less likely

In conclusion, the status quo should be preferred, until we have evidence to support that there will be benefits of treatment at the lower cut-off point.

________________________________________________________________________________________

Pro International Association of Diabetes and Pregnancy Study Group
Boyd E. Metzger, M.D.
Emeritus Professor, Department of Medicine
Division of Endocrinology, Metabolism and Molecular Medicine
Northwestern University
Feinberg School of Medicine

From Dr. Metzger’s perspective, the impetus for change did not come from HAPO.  It started back In 1978, when a group of people appointed by the National Institutes of Health came together to work on the diagnoses of diabetes and GDM. It took a year and a half for this group to come out with some very important recommendations. Importantly, they established a universal framework for diabetes, including the language of “Type 1″ and “Type 2″ diabetes. They also described the diagnostic criteria for diabetes, which were linked to outcomes. On the other hand, GDM was considered a major exception to the rule, because there was less evidence available– so they could not link diagnostic criteria to outcomes. Instead, the working group linked the diagnostic criteria for GDM to women’s risk of developing Type II diabetes in the future. There was a minority group even back then who thought that lower values should be diagnosed as GDM.

Between 1979-2013, there was much controversy and discussion over GDM. The 2 major questions are:

1) Can adverse outcomes be linked to hyperglycemia during pregnancy, or are they due to confounding factors such as obesity?

2) Is there an effective treatment that can improve outcomes of GDM?

Well, the HAPO study helped answer the first question. The results indicated that as glucose levels rise, the frequency of a whole series of adverse outcomes increases (including birth weight and high insulin in the infants, pre-term birth, preeclampsia, shoulder dystocia, and jaundice). The researchers found that these GDM-related outcomes are independent of the mother’s age, body mass index, and family history of diabetes. So the link remains, even after you take into account confounding factors. These results were consistent at all of the HAPO study locations all around the world.

So then the IADPSG took these results and used them to develop “outcome-based” criteria for diagnosing GDM.

Before they started the HAPO study, the IADPSG researchers agreed upon odds ratio that they  would use for a new cut-off point (1.75). This means that if there was a 1.75 increase in the risk of high birth weight, fetal fat distribution, and high insulin levels in the infant, then that would be the glucose level where they would set the cut-off for GDM.

Why did they pick birthweight, fetal fat distribution, and high insulin levels to be the main outcomes on which they based the IADPSG diagnostic criteria? Because the HAPO study was powered to detect differences in these outcomes, and because these outcomes are linked with other outcomes (like C-sections). The group making the IADPSG recommendations also looked at the HAPO data using either 1 abnormal value or 2 abnormal values to diagnose GDM. They considered other possible combinations, other odds ratios (such as 1.5 or 2.0). In the end, because poor outcomes rise in a linear fashion corresponding to blood sugars, where you draw the line is an arbitrary decision. But they felt like this was the best place to draw the line. It should be noted that back in the 1960′s when the first cut-off for GDM was proposed (the O’Sullivan approach), this was also an arbitrary cut-off.

When Dr. Metzger addressed the concerns about the potential increased number of diagnoses, he said that the number of diagnoses of GDM should reflect what we see in the general non-pregnant female population. The most recent NHANES data showed that 2.8% of U.S. women age 18 to 44 have diagnosed diabetes, 1.7% have undiagnosed diabetes, and 26.4% have pre-diabetes (impaired glucose tolerance). Taking into account the fact that during pregnancy you see an increase in insulin resistance, we are not going to see a decrease in women with glucose abnormalities. So if 30.9% of U.S. women age 19-44 have impaired glucose tolerance, why do we consider 18% an unreliable number?

Another concern that people have raised is that the recommendations are not validated by evidence from randomized, controlled trials. Dr. Metzger compared the ACHOIS and MFMU populations with the HAPO study, and he stated that the populations were not that different. The fasting glucose was very similar, and there was only a slight difference in the 2-hour glucose values.

So why should we use the IADPSG recommendations?

  • Cut-offs would actually be based on mother-baby outcomes
  • Using a 75 gram 2 hour test would allow consistency around the world for both pregnant and non-pregnant patients
  • Because we have an international source of data (the HAPO study) with input from multiple countries, this will enhance the adoption of these criteria
  • We have been waiting for 30 years for this change, so please, let’s move forward

________________________________________________________________________

Pro Alternative
Presented by Edmond A. Ryan, MD
Professor, Department of Medicine
Division of Endocrinology
University of Alberta

Dr. Ryan has a website for women with GDM– you should check it out. He is from Canada and in his talk he offered an alternative way forward.

It is well-known that Type I diabetes in pregnancy has risks of congenital defects. It is also known that if Type II diabetes goes undiagnosed and untreated, then it can have risks for mother and baby. We also know that hyperglycemia (GDM) has adverse outcomes.

Dr. Ryan gave a brief overview of the ACOG-recommended 2-step process, the IADPSG 1-step process, and an alternative 2-step process that he is proposing.

In the alternative process, women would be screened with the 50 gram 1 hour test, and if women test in the upper limits than they would be presumed to have GDM. Others who screen positive would undergo a 75 gram 2 hour test, with 1 abnormal value being considered GDM.

Dr. Ryan thinks that we should be doing what’s best for babies– and what is truly best for babies based on evidence. One of the problems with the tests for GDM is that they are not reproducible. If you have a slightly abnormally result, you could take the test next week and it could be completely normal. However, if the TWO-STEP process is used, a woman with a single abnormality on a single test is less likely to have an abnormal test on repeat. In Dr. Ryan’s opinion, we need to be VERY careful about making a diagnosis based on a single lab value, because a single test is poor evidence.

The alternative that Dr. Ryan is proposing would be to use an odds ratio cut-off of 2.0 instead of 1.75. This means that whatever glucose levels result in a 2-fold risk for poor outcomes, then we should use that as a cut-off (the IADPSG group is recommending the 1.75 cut-off). Dr. Ryan talked about how obesity is a stronger predictor of large baby than GDM test results (Ricart et al., 2005). In the HAPO study with 23,316 women, there were 311 cases of shoulder dystocia and/or birth trauma. More than three-fourths of these cases occurred in women with glucose levels BELOW the IADPSG threshold– in otherwords, most cases of shoulder dystocia occur in women without GDM. Also, in the majority of women with high glucose, their outcomes were just fine.

Dr. Ryan states that when you look at the evidence in total, the current ACOG recommendations for the 2-step screening process are not based on good evidence. On the other hand, the IADPSG and the “alternative” methods are evidence-based, because they link the diagnosis with actual outcomes. So now we need to look at the benefit/harm ratio of these methods. Whichever one has the best benefit/harm profile would be the one we should pick.  

What about benefits and harms of testing for GDM? Some practical drawbacks include patient time, inconvenience, and discomfort, as well as the number of blood draws. The 3 hour 100 gram test (required by ACOG in their 2-step process) requires more time off work and leads to more nausea.

Interestingly, the benefits of treating GDM are not striking. Large numbers of women would need to be treated in order to show a benefit. In the ACHOIS study, there was a reduction of the combined endpoint of serious complications– but not in each these complications individually. There were 5 stillbirths in the control group, but 1 was small for gestational age (not related to  GDM), and 1 was congenital malformations (not related to GDM). The difference in stillbirths between groups was not statistically significant.

Diagnosing GDM has actual consequences. The mother would need more clinic visits and would need to undergo frequent glucose testing, therapy, obstetrical monitoring/induction, and she would have to endure the “label” of diabetes. The label of GDM increases a woman’s insurance premium in 48 states. For the baby, this could lead to unnecessary NICU admissions (due to the “label”), and early inductions.

In the U.S., our ”pie” is only so big, and the “sequester pie” is even smaller. Is it really fair for society to spend so much money on these additional diagnoses of GDM, when things like obesity may be more important?

Some people say until we get definitive studies we should do nothing. But in practice, Dr. Ryan says that we need to do something. The truth is, the most important thing is to catch women with overt, undiagnosed Type II diabetes. In the meantime, we should hold onto the 50 gram screening test– systematic review supports its use, women prefer it, and it’s more cost-effective. This test would be followed by the 2 hour 75 gram test in women who screen positive (unless they have a result of more than 200, in which case they would automatically be diagnosed with GDM).

In summary: GDM is a treatable cause of large babies and it is worth detecting. However, GDM accounts for a small minority of large babies– other factors are involved, especially obesity. We need to demonstrate elevated glucose on 2 occasions. In the long-term, we need to find the real culrprit for most large babies, since it’s obviously not GDM. In the short-term, we need to determine whether treating obesity is a more acceptable and practical approach. In the mean-time, the alternative 2-step approach for diagnosing GDM is the most reasonable step forward.

______________________________________________________________________________________

Want to read more about gestational diabetes? Check out these articles written by Evidence Based Birth:

Gestational Diabetes and the Glucola Test

Does Gestational Diabetes always mean a Big Baby and Induction?

Posted in: Evidence based practice, Gestational diabetes

Leave a Comment: (0) →

Diagnosing Gestational Diabetes: The NIH Consensus Conference Day 1

Diagnosing Gestational Diabetes: The NIH Consensus Conference Day 1

March 4, 2013

For two days (March 4 and March 5, 2013), I live-blogged the NIH Consensus Development Conference on Diagnosing Gestational Diabetes. The purpose of this conference is to come to a consensus on two things: the best way to diagnose gestational diabetes (GDM), and whether we should change the criteria we use to diagnose GDM in the U.S.

This blog post covers day 1 of the conference. To read about the information  presented on day 2, click here.

Note: The information presented in this blog comes directly from the presentations at the conference, and does not necessarily represent my opinion or the opinion of Evidence Based Birth.

What implications does the GDM consensus conference have for women and babies?

What implications does the GDM consensus conference have for women and babies?

The topics that will be covered include:

  • What are the current screening and diagnostic approaches for gestational diabetes mellitus, what are the glycemic thresholds for each approach, and how were these thresholds chosen?
  • What are the effects of various gestational diabetes mellitus screening/diagnostic approaches for patients, providers, and U.S. healthcare systems?
  • In the absence of treatment, how do health outcomes of mothers who meet various criteria for gestational diabetes mellitus and their offspring compare with those who do not?
  • Does treatment modify the health outcomes of mothers who meet various criteria for gestational diabetes mellitus and their offspring?
  • What are the harms of treating gestational diabetes mellitus, and do they vary by diagnostic approach?
  • Given all of the above, what diagnostic approach(es) for gestational diabetes mellitus should be recommended, if any?
  • What are the key research gaps in the diagnostic approach of gestational diabetes mellitus?

___________________________________________________________

Overview of the Problem of Gestational Diabetes
Presented by Catherine Spong, MD
Associate Director
Extramural Programs
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health

Gestational diabetes is defined as a carbohydrate intolerance of varying severity that occurs in about 7% of pregnancies in the U.S. It’s estimated that GDM has an annual economic burden of $636 million in the US. The criteria for diagnosing GDM were established 30-40 years ago. The test for GDM was designed to identify women who were at risk for developing diabetes later in life. It was NOT designed to identify women who were at risk for poor outcomes in pregnancy.

Outside the US, the typical test is a 2 hour, 75 gram oral glucose test. In the US, women are given a 1 hour 50 gram glucose test, and if that is positive, then they undergo a 3 hour 100 gram glucose test.

Rates of obesity are increasing in the U.S., and so are rates of GDM. When women develop GDM, they are at higher risk for are adverse pregnancy outcomes and long-term negative outcomes for mom and baby. Potential complications  of GDM include preeclampsia, higher weight gain in the fetus, and an increased risk for C-section, newborn complications, and of the mother developing Type II diabetes after pregnancy.

There are 3 main controversies related to GDM:

Controversy #1: Screening: It’s very controversial whether we should screen all women or just women at higher risk. The U.S. Preventative Health Service does not recommend routine screening (2008), citing insufficient evidence for this practice. This group has met again and will be coming out shortly with a new recommendation on screening.

Controversy #2: Effectiveness of Treatment. Before 2005, there was no evidence that treatment improves outcomes. Since that time, 2 large randomized, controlled trials have found that screening and treatment of GDM have decreased the risk of large babies and shoulder dystocia. The HAPO study, which looked at 25,000 women, found that adverse outcomes related to high blood sugar happen on a continuum. There is NO clear cut-point where we can say, “This is normal and this is abnormal.”

Controversy #3: New Criteria. The International Association of Diabetes in Pregnancy Study Group and the American Diabetes Association have recommended new criteria for diagnosing GDM. These criteria are based on pregnancy outcomes, and the cut-offs were defined by the risk of a woman experiencing adverse outcomes. But if these new criteria are adopted, it will double or triple the number of GDM diagnoses to 1 in 5 women, or 18%. This will cost an extra $2.5 billion annually. But there is NO evidence that treatment of these new GDM diagnosis thresholds will improve outcomes. The other clinical trials (mentioned in #2) only looked at treatment of women using the OLD criteria.

This conference will NOT state whether or not screening should occur. The conference is also NOT going to cover  GDM management and treatment options.

The conference WILL address these 2 questions: What should the diagnostic threshold be? And should the current diagnostic criteria be changed?

Other purposes of this conference are to:

  • Raise awareness of GDM and its complexities
  • Talk about the lack of clarity related to diagnosing GDM
  • Evaluate the evidence in a rigorous fashion
  • Develop a consensus statement about the diagnosis of GDM

__________________________________________________________

Epidemiology of GDM
Presented by Dr. William Callaghan, MD, MPH
Chief, Maternal and Infant Health Branch
Division of Reproductive Health
National Center for Chronic Disease Prevention and Health Promotion
Centers for Disease Control and Prevention

Epidemiology is the study of how diseases are distributed across populations. It looks at the burden of disease, as well as causes, risk factors, prognosis, and the effectiveness of treatment and prevention strategies.

Using hospital discharge codes, the percentage of pregnant women who have been diagnosed with GDM has risen from 3.3% in 1998 to 5.6% today. Currently, GDM affects about 200,000 women per year in the U.S. The new birth certificate also has a place to enter GDM. Using birth certificate data, researchers found that in 2008, 4.1% of babies were born to mothers with GDM. Although these data make it seem like GDM is increasing, it is very difficult to tell whether the increase is due to an actual increase or due to changes in screening.

In fact, the frequency of GDM really depends on how it’s diagnosed. If you have different cut-points, you will have different numbers of diagnoses. In looking at population data, we rarely know what test or what cut-off people used to diagnose GDM. In some studies, where we know what test people used to diganose GDM, the rates of GDM have remained stable.

There is a clear dose-response effect related to obesity and GDM. In other words, the higher your body mass index, the more likely you are to develop GDM. About half of all cases of GDM are thought to be caused by overweight and obesity– but this statement assumes that obesity is a cause of GDM. In Dr. Callaghan’s opinion, there is strong evidence that obesity is a cause of GDM.

What happens after pregnancy? Anywhere from 20-50% of women with GDM will eventually develop Type II Diabetes. Increasing evidence shows that we need to pay attention to these women in the post-partum time period. But only half of women with GDM are tested for diabetes after pregnancy.

In summary, it appears that the percentage of women with GDM in the U.S. is 5-6%. The trend has been for GDM to increase, but it seems like the increase has leveled. On the other hand, more women have Type II Diabetes in pregnancy. The new cut-off points proposed by the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) and the American Diabetes Association will result in a dramatic increase in the number of women diagnosed with GDM.

___________________________________________________________

Current Diagnostic Methods and Thresholds of Gestational Diabetes Mellitus
Presented by Donald R. Coustan, MD
Professor of Obstetrics and Gynecology
Warren Alpert Medical School
Brown University

There are many different ways to diagnose GDM. Some professional and government groups recommend a 75 gram glucose test, and some groups recommend a 100 gram test. There are also different cut-offs for these tests at different time points in the test. To make matters more confusing, some organizations recommend a 1-step process for diagnosis, while others recommend a 2-step process (a screening test followed by a diagnostic test).

In the U.S., the most common criteria are based on the original “O’Sullivan & Mahan” criteria. To help us understand this, the speaker covered some basic history about diagnosing GDM.

So what is the history about the diagnostic test for GDM?

Gestational diabetes was first written about in 1882. In 1952, it was first recognized that there may be poor outcomes associated with GDM.

In 1964, O’Sullivan and Mahan proposed that pregnancy changes the metabolism of carbohydrate, and that these changes are different than what happens outside of pregnancy. They published a study with 752 women who took a 100-gram 3-hour glucose test in the 2nd or 3rd trimeste. In this study, the researchers tried out different cut-offs for GDM.

The cut-offs they came up with are listed below. In order to diagnose GDM, O’Sullivan and Mahan required a woman to have 2 or more abnormal values during the test. The purpose of having 2 abnormal values was to make sure that you weren’t making a diagnosis on a single blood test. These tests were based on using whole blood, and so these numbers are no longer relevant today (since now we use plasma instead of whole blood)

  • Fasting = 90 mg/dL
  • 1 hour = 165 mg/dL
  • 2 hr = 143 mg/dL
  • 3 hr = 125 mg/dL

O’Sullivan and Mahan followed these women for 20 years, and about 63% of the women with GDM developed Type II diabetes, compared to 5% of women who did not have GDM.

Twelve years after this research was published, Williams’ Obstetrics included the O’Sullivan & Mahan criteria in their textbook. Two years later, in 1978, ACOG recommended these criteria as well.

These criteria were converted to meet the way we are now measuring blood using plasma. These are called the National Diabetes Data Group (NDDG) criteria:

A woman is given a 100 gram 3 hour test. If 2 or more of these values are met, then she is diagnosed with GDM.

  • Fasting = ≥ 105 mg/dL
  • 1 hour = ≥ 190 mg/dL
  • 2 hr = ≥ 165 mg/dL
  • 3 hr = ≥ 145 mg/dL

There are several other criteria that are important to know, because they are also used (numbers taken from a different presentation):

Carpenter and Coustan Criteria:

A woman takes a 100 gram 3 hour test. If 2 or more of these values are met, then she is diagnosed with GDM.

  • Fasting = ≥ 95 mg/dL
  • 1 hour = ≥ 180 mg/dL
  • 2 hr = ≥ 155 mg/dL
  • 3 hr = ≥ 140 mg/dL

In 1991, researchers held a 3rd International Conference on GDM. They came to a consensus was that there was a major problem with diagnosing GDM, because different criteria were being used all around the world. Also, these criteria were not based on pregnancy outcomes, but on the risk of developing Type II Diabetes after pregnancy.

In 1994, ACOG recommended using either the Carpenter and Coustan criteria or the NDDG criteria.

In 2011, the American Diabetes Association recommends new criteria from the International Association of Diabetes and Pregnancy Study Group (IADPSG). These are the criteria that this consensus conference is about– should we adopt these criteria, or not?

In the meantime, ACOG continues to recommend the Carpenter & Coustan or NDDG criteria, and ACOG does NOT recommend the IADPSG criteria.

The new IADPSG criteria:

A woman takes a 75 gram 2 hour test. If she has one value at or above the cut-off, then she is diagnosed with GDM.

**These cut-offs aren’t that much lower than the other ones. The reason the number of women who will test postive will triple is because you only need ONE positive value to be diagnosed instead of two.

  • Fasting = ≥ 92 mg/dL
  • 1 hour = ≥ 180 mg/dL
  • 2 hr = ≥ 153 mg/dL

What about the 50-gram 1 hour screening test?

In 1973, O’Sullivan described the 50-gram, 1 hour screening test. Carpenter & Coustan converted the numbers to meet current blood testing standards. The cut-off was 143, but this was not sensitive enough. So they proposed 2 new cut-offs: either 130 mg/dL or 140 mg/dL.

In 1986, ACOG recommended the 50-gram 1 hour screening test for women at risk (this was based on the opinion of experts and not based on research evidence).

In 2001, ACOG recommended the 50 gram 1 hour test for ALL pregnancies except for perhaps women who are at very low-risk for GDM (<25 years, normal weight, among other criteria).

The newly recommended IADPSG criteria are actually somewhere in the middle between other organizations and actually have a higher cut-off than the World Health Organization’s recommendations.

If the IADPSG criteria were adopted, the biggest change would be the transition from TWO elevated values to ONE elevated value. In the landmark HAPO study, 64% of women were diagnosed based on a single elevated value rather than 2 elevated values. So that’s the big change that has been proposed– that all women would take the 2-hour test, and if there is one elevated value, then that equals a diagnosis of GDM.

____________________________________________________________

Comparative Benefits and Harms of Varying Diagnostic Thresholds of Gestational Diabetes Mellitus
Presented by Wanda Nicholson, MD, MPH, MBA
Director, Diabetes and Obesity Core
Center for Women’s Health Research
Associate Professor, Department of Obstetrics and Gynecology
The University of North Carolina School of Medicine

Gestational diabetes and can be an ongoing cycle for mothers and infants. Infants may have short-term adverse outcomes such as accelerated growth, while mothers can have increased amounts of postpartum weight retention. In the long-term, infants are at higher risk for childhood and adult obesity, and women are at higher risk for future diabetes and increasing body mass index.

The criteria for diagnosing GDM are evolving, because our goal is to reduce adverse outcomes in women and infants.

As previously stated, the Carpenter & Coustan diagnostic criteria consists of a 100 gram 2 hour test. If there are 2 or more positive values, then a woman is diagnosed with GDM.

The newly proposed criteria consists of a 75 gram 2 hour test, with NEW cut-offs. Only one elevated level would be needed to diagnose a woman with GDM.

Why is this change important?

The HAPO study found that many women have diabetes but are not recognized as being diabetic. Also, they found that glucose levels below the current cut-off are associated with higher birth weights and metabolism alterations in the infant. But the main issue is that this will increase the prevalence of GDM from 5-7% to 18%. This is a three-fold increase in the number of women who will be diagnosed with GDM.

Why the controversy? Well, different people have different perceptions of harms and benefits. And there are major concerns about implementing this, and about our healthcare systems ability to absorb this change.

How do we implement this in the “real world?” Let’s look at the concerns of the major stakeholders: the 4 million US women giving birth each year, care providers, and diverse clinical settings.

Stakeholder #1: Concerns of Women.

A change in the criteria would mean switching from the 2-step process (the 50 gram, 1 hour test, which is followed by a 3-hour, 100 gram test if necessary) to the 1-step test. All patients would need to come fasting to the test and they would have to drink a 75 gram drink and stay for 2 hours. More women newly diagnosed with GDM would have to spend more time at prenatal visits, and they would have an increase in fetal testing and ultrasounds. There will be lots of ultrasounds to assess fetal growth, and unfortunately these ultrasounds can lead to an increase in unnecessary C-sections for suspected “big baby.”

With regard to psychosocial problems, there is limited evidence on this.  One study suggested that women with GDM who are treated have lower rates of depression than women who have GDM and do not receive treatment. But so far that is the only data we have about psychosocial issues.

Finally, labor induction usually occurs at 39 weeks of pregnancy in women with GDM, and C-section rates vary widely across settings. Physicians may be more likely to make decisions that lead to a C-section because of concerns about fetal status.

Stakeholder #2: Concerns of care providers.

More appointments would be needed for a larger number of women with GDM. It would take more time to assess and manage patients’ glucose levels. Clinics would need to staff more people who could provide nutritional counseling and diabetes education.

If we are going to have an ever-increasing number of women with this diagnosis, then we will need new tools and ways for care providers to care for these women.

Another issue is that only about half of women with GDM are screened for GDM 6-12 weeks after giving birth– these numbers need to improve. This screening requires a fasting state and good patient-care provider communication.

Other questions that concern stakeholders: Should we be developing models of care to improve lifestyle habits after delivery? Should we consider extending the perinatal period to 6 months to 1 year after delivery so that we can follow and manage these women who are at higher risk for developing Type II diabetes?

How can we get informed, active patients and educated healthcare providers?

Stakeholder #3: Health Care System

We have a few major questions that remain unanswered:

  • How would we get the word out about the change in screening?
  • How do we deal with increased laboratory workload?
  • What will this do to C-section rates?

In summary, key points to ponder:

Are there potential harms with over-treatment? Will this take more resource utilization? How can we move forward with patient-centered care during pregnancy and beyond?

_____________________________________________________________

Relative Hyperglycemia and Health Outcomes for the Mother and the Fetus
Presented by Lois E. Donovan, MD, FRCPC
Clinical Associate Professor and Medical Director
Diabetes in Pregnancy, Division of Endocrinology and Metabolism
Department of Obstetrics and Gynecology
University of Calgary, Alberta Health Services

Also Presented by Lisa Hartling, PhD
Assistant Professor, Department of Pediatrics
Director, University of Alberta Evidence-based Practice Centre
Alberta Research Centre for Health Evidence
University of Alberta

Dr. Hartling and Dr. Donovan conducted a systematic review on the evidence for this topic. They combined the data from different studies using meta-analysis, where appropriate.

They looked at primary research studies published in English from 1995-2012, in which women diagnosed with GDM received no treatment. They ended up looking at 38 studies (14 in the U.S.). Most studies used the Carpenter & Coustan criteria to diagnose GDM.

What did they find?

If women were diagnosed with the IADPSG criteria, they were 2 times more likely to have a large baby. If they were diagnosed witih the NDDG criteria, they had a 2.5 times higher risk of having a large baby. The Carpenter and Coustan criteria had a 1.6 risk ratio, and the World Health Organization criteria had a 1.3 risk ratio.

All of the different diagnostic criteria were able to identify women who were at significantly higher risk for shoulder dystocia. Using the NDDG criteria, women were 6 times more likely to have shoulder dystocia, compared to 1.5 risk ratio using the IADPSG criteria, and there was a 2.9 risk ratio using the Carpenter & Coustan criteria.

For C-sections, all of the different ways of diagnosing GDM were associated with a 1.2-1.4 higher risk of having a C-section compared to women who did not have GDM.

There was no difference in infant mortality for women with GDM compared to women without GDM. This was consistent using all of the different criteria for diagnosing GDM.

_____________________________________________________________

Relative Hyperglycemia and Health Outcomes for the Mother
Presented by Patrick M. Catalano, MD
Professor, Reproductive Biology
Director, Center for Reproductive Health
Department of Obstetrics and Gynecology
MetroHealth Medical Center
Case Western Reserve University

Dr. Catalano’s theory is that there is an underlying factor that women begin pregnancy with that is what leads to GDM and future Type II DM. In other words, having GDM doesn’t cause you to have Type II Diabetes later… you already had that risk to begin with, before you got pregnant.

The HAPO study (the largest study to date on GDM) found that there was a continuous relationship between glucose and higher infant weights, preeclampsia, and several other outcomes.

What about long-term risks after GDM? It’s recommended that women with GDM be tested for diabetes post-delivery, 6 weeks, 1 year, and annually. This is because in looking all of the studies, in the first 5 years after GDM there is a significant risk of developing impaired glucose tolerance (30% of women). Ten years later, about 50-60% of women will have impaired glucose tolerance. (Impaired glucose tolerance is sometimes referred to as “pre-diabetes.”)

Other researchers have found that by 12 months post-partum, 18% of women with GDM progressed to pre-diabetes or Type II diabetes.

So what are the risk factors for progressing to Type II diabetes after GDM? One study found that there are some statistically significant risk factors, but they are not clinically significant. For example, women with GDM who progress to Type II diabetes are more likely to have a blood pressure that is 3 points higher than women who do not develop Type II diabetes, but that is not a clinically different finding.

Another study found that factors associated with progression to pre-diabetes included higher fasting glucose, insulin use during pregnancy, and an earlier diagnosis of GDM during pregnancy. Surprisingly, body mass index was not a predictor of progression to pre-diabetes after pregnancy.

One group of researchers followed women for 7 years after they had a GDM diagnostic test. Some women had normal results, others had one abnormal value, and others had 2 abnormal values and qualified for a diagnosis of GDM. There were no significant differences between the women who had 1 abnormal value and those who had 2 abnormal values– these two groups were at equally high risk for developing pre-diabetes 7 years later.

What is the benefit of knowing a woman’s risk for developing Type II diabetes after GDM? Well the benefit is that you can do something about it. If you know someone with GDM is at risk for developing Type II, they can engage in intensive lifestyle changes that will drastically lower their risk of developing Type II diabetes.

Also, studies have shown that treating mild GDM can reduce the mother’s weight gain during pregnancy.

In summary, as early as 3 months postpartum, women with GDM are at increased risk for pre-diabetes. Lifestyle interventions can prevent the progression to Type II diabetes.

____________________________________________________________________________

Relative Hyperglycemia and Health Outcomes for the Fetus
Presented by David J. Pettitt, MD
Senior Scientist
Sansum Diabetes Research Institute

First, Dr. Pettitt summarized the 2 randomized, controlled trials looking at treatment for mild GDM.

The first study is the Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS). This is a randomized controlled trial of treatment for mild GDM (Crowther et al., 2005). Using the World Health Organization’s diagnostic criteria, 524 women with mild GDM were randomized to treatment or no treatment. The primary outcome was a combined outcome of any serious complication such as stillbirth or neonatal death (number [n] = 5, all in the control group), shoulder dystocia, nerve palsey (n = 3, all in the control group), and bone fracture (n = 1). The other primary outcomes were NICU admission and jaundice requiring phototherapy. Secondary outcomes included birth weight and large for gestational age.

What did they find? The researchers found that the rate of serious complications was lower in the treatment group (1% vs. 4%). However, more babies in the treatment group were admitted to the neonatal nursery (71% vs. 61%). Infants born to women in the treatment group had lower birth weights and there were fewer infants who were large for gestational age. Infants in the treatment group were born at an earlier gestational age, and more women in the treatment group were induced.

The other big randomized controlled trial was the MFMU trial for treatment of mild GDM. Women (n = 473) were randomized if they were diagnosed with mild GDM based on ACOG’s recommendations for diagnosing GDM. The primary outcome was a composite endpoint of stillbirth or neonatal death (of which none occurred) and serious complications, and secondary outcomes were birth weight, large for gestational age, preterm delivery, and NICU admissions.

What did they find? As noted earlier, there were no deaths in either group. There was also no difference between groups with any of the serious complications or NICU admissions. However, the treatment group did see a decrease in average birth weight, percentage of large babies, shoulder dystocia, C-sections, and a combined measure of preeclampsia and gestational hypertension. There was no difference in inductions between the 2 groups.

Next, he went on to talk about several observational studies.

In the HAPO study, when glucose values were above the threshold, researchers found a host of outcomes that were more frequent in women with GDM. These included high birthweight, preeclampsia, C-section, shoulder dystocia, newborn low blood sugar,  and newborn jaundice. Rates of stillbirth or neonatal death were not higher among women with GDM.

In another study, when researchers examined body mass index and GDM, more than 20% of women who were obese and had GDM gave birth to infants that were large for gestational age, compared to 10% of women who were obese without GDM.

What about long-term follow-up? In the ACHOIS study, they described outcomes of the children 4-5 years later. About 28% of children were above the 85th percentile for body weight. In a normal population you would expect about 15% to be above the 85th percentile. There was no difference in body weight between offspring of the treatment group and offspring of the control group.

In the HAPO study, there was no association between maternal glucose during pregnancy and the infant’s weight/obesity at age 2 years.

In the ACOG/ADA study, if a woman’s 1-hour 50 gram glucose was <130 mg/dL, then her 3 year old was more likely to have a higher body mass index. There was a positive relationship between the 50 gram 1 hour glucose test and the body mass index of children at age 5-7 years follow-up. The children of women who were treated in this study had less obesity– this is the only study to date to show that treatment for GDM can decrease obesity in offspring.

In the Pima Indians study (Petttitt et al., 1991), the mother’s glucose during pregnancy had a direct effect on the weight of children at age 10-14. This effect persisted up through at least the age of 20-30 years in the offspring of these women.

___________________________________________________________________

Benefits of Treatment of Gestational Diabetes Mellitus on Maternal and Fetal Health Outcomes
Presented by Lois E. Donovan, MD, FRCPC
Clinical Associate Professor and Medical Director
Diabetes in Pregnancy
Division of Endocrinology and Metabolism
Department of Obstetrics and Gynecology
University of Calgary
Alberta Health Services

Also presented by Lisa Hartling, PhD
Assistant Professor
Department of Pediatrics
Director
University of Alberta Evidence-based Practice Centre
Alberta Research Centre for Health Evidence
University of Alberta

Again, Dr. Donovan and Dr. Hartling revealed more results from their systematic review. The review included 5 randomized, controlled trials and 6 cohort studies.

The 2 largest randomized, controlled trials drive most of the findings. The ACHOIS study used the World Health Organizatoin diagnostic criteria, and the MFMU study used the Carpenter and Coustan criteria. So although these studies included women with a similar average fasting glucose, ACHOIS study included women with a fasting blood sugar of 74 to 99,  thewhile the MFMU study included women with a fasting glucose of 81 to 92.

The results of Donovan and Hartling’s meta-analysis showed that there was a 50% reduction in macrosomia (large baby) with treatment for GDM. This means that you would need to treat 18 women to prevent 1 case of macrosomia. Similarly, they found that treatment for GDM resulted in a 50% risk reduction in large for gestational age babies. There was a 60% reduction in shoulder dystocia. But because shoulder dystocia is such a rare event (4%), you would need to treat 50 women with GDM to prevent 1 case of shoulder dystocia.

For preeclampsia, treatment for GDM resulted in a 40% reduction in the risk of preeclampsia. The baseline risk for this is 5.5%. You would need to treat 29 women with GDM to prevent 1 case of preeclampsia.

There were no data on long-term outcomes for women, so we cannot tell if treatment for GDM improves long-term outcomes.

For long-term metabolic outcomes for children, 2 of the randomized, controlled trials found no difference in body mass index or type II diabetes in offspring. The ACHOIS study found no difference in BMI >85th percentile between the treatment and control groups, even though there were fewer cases of large babies in the treatment group.

Research is needed to follow-up offspring from randomized controlled trials. Clinical trials are needed to randomize women to different treatment targets, different surveillance frequencies, and different labor and delivery protocols.

________________________________________________________________________

Benefits of Treatment of Gestational Diabetes Mellitus on Maternal Health Outcomes
Presented by Mark B. Landon, MD
Professor and Chair, Department of Obstetrics and Gynecology
The Ohio State University College of Medicine and Wexner Medical Center

GDM includes a wide spectrum of women with a wide range of blood sugars and risks. Attention has been paid primarily to perinatal outcomes such as macrosomia (large baby). A recent systematic review and meta-analysis in the British Medical Journal concluded that treatment of GDM is associated with a decrease in shoulder dystocia and macrosomia. However, treatment for GDM did not reduce C-sections. Importantly, the authors of the meta-analysis did not look at preeclampsia or gestational hyperttension in their systematic review.

It is important to note that preeclampsia and gestational hypertension are much higher in women with GDM. But many studies have not adjusted for confounding variables such as obesity. Two studies that controlled for confounders found that women with GDM are twice as likely to experience preeclampsia and gestational hypertension.

A secondary data analysis from the HAPO study found that women with GDM have much higher rates of preeclampsia and gestational hypertension, regardless of whether they are normal weight or obese.

One large retrospective study included more than 1,800 women with GDM and found a dose-response relationship between fasting blood sugar and the frequency of preeclampsia and gestational hypertension. If the fasting glucose level was <95, only 7.5% of women had preeclampsia or gestational hypertension. On the other end of the spectrum, if women had a fasting glucose of more than 126, then 20% of these women had preeclampsia or gestational hypertension.

Women with a fasting glucose of more than 126 have a four-fold increase in their risk of preeclampsia. If women have a fasting glucose of 106-115, they have a 2-fold risk of developing preeclampsia. (Yogev et al.) The HAPO study found similar results.

In the MFMU study (of which Dr. Landon, the presenter, was the principal investigator), there were similar rates of preeclampsia between women with one abnormal value on the diagnostic test and women with two abnormal values.

So the important question is, does treatment of GDM reduce the risk of preeclampsia and gestational hypertension?

Both of the large randomized, controlled trials (ACHOIS and MFMU) demonstrated that treatment for mild GDM reduced the risk of preeclampsia and gestational hypertension. In the MFMU study (conducted by Dr. Landon, the presenter), researchers found that treatment for GDM reduced the percentage of women with preeclampsia and hyertension from 13.6% to 8.6%.

However, there is little evidence about treating women who had only one abnormal value on their GDM diagnostic test. There was one small study done in 1989–  in that study, researchers found that treatment failed to reduce the rate of preeclampsia in women with one abnormal test.

Most recently, Bodner-Roy published an article about the odds of preeclampsia in women with and without GDM, using the newly proposed IADPSG diagnostic criteria for GDM. They did not find a significant difference in preeclampsia between women with and without GDM using the new IADPSG criteria. So evidence does not suggest that treating women with the lower glucose values (included in the newly proposed diagnostic criteria) will reduce their risk of preeclampsia.

What about C-section rates in women with GDM?

Women with GDM consistently have higher C-section rates (24% vs. 17%; pooled data from 5 studies). Physicians are scared of birth trauma and large for gestational age infants, which may contribute to the higher C-section rates in women with GDM.

In a study conducted by Naylor et al., there was a clear increase in C-sections in women who are treated with GDM, compared to those who were not treated. Other researchers have consistently reported higher C-section rates in women who are treated for GDM, even though they give birth to smaller infants. This is probably because physicians have a lower threshold for surgery and are quicker to do a C-section if they know a woman has GDM.

However, the odds for C-section may change based on body mass index. Obesity independently increases the risk for C-section. There is a synergistic effect between obesity and GDM. If you have both obese AND you have GDM, your risk for C-section goes up even higher.

In contrast, the MFMU study found that treatment of GDM led to a decrease in the C-section rate (27% vs. 34%).

There is limited evidence (one study from 1989) on treating women with ONE abnormal glucose value and C-section rates.

The HAPO researchers found a dose-response relationship between glucose categories and C-section rates. The risk for C-section rate increased with each category.

In Dr. Landon’s opinion, lowering the diagnostic cut-off for GDM would probably not lead to a lowering of C-section rates.

In summary:

  • Treatment for GDM decreases the risk for gestational hypertension and preeclampsia
  • Labeling a woman with GDM may make her more likely to have a C-section rate
  • The overall effect of treatment for GDM on the C-section rate is not clear

_________________________________________________________________________

Benefits of Treatment of Gestational Diabetes Mellitus on Fetal/Infant Health Outcomes
Presented by Matthew W. Gilman, MD, SM
Director, Obesity Prevention Program
Professor, Department of Population Medicine
Harvard Medical School
Harvard Pilgrim Health Care Institute

Dr. Gilman began by giving an overview of the ACHOIS and MFMU clinical trials. Both trials had similar treatments for GDM: dietary counseling, glucose monitoring, and insulin if needed (7-20% of women took insulin).

The ACHOIS found that you needed to treat 34 women with GDM to prevent 1 serious perinatal complication, and if you treated 11 women this would lead to 1 additional induction of labor or admission to the neontal nursery.

The main finding of MFMU was that there was no change in the primary outcome (serious complications). There was a reduction in macrosomia (large baby) and large for gestational age infants, as well as a decrease in fat mass in infants in the treatment group.

Treatment of mild-moderate GDM reduces the risk of preeclampsia, shoulder dystocia, large for gestational age, and macrosomia. The effects on C-section and serious complications are unclear. The HAPO study does not really provide us with info to choose a cut-point for diagnosing GDM.

There have been 4 small, randomized, controlled trials that tested a treatment for GDM in women who did not meet the current criteria for gestational diabetes. When these data were combined, there was a decrease in the risk of macrosomia, but an increase in the risk for small for gestational age.

An argument can be made for treating lower risk women for public health reasons. Even though the individual risk of bad outcomes is lower in women with lower glucose scores, the overall public health burden is higher.

BUT, Dr. Gilman pointed out that we have some experience with doing similar treatments in the cardiovascular field. For example, we started treating people with lower cholesterols with statin drugs, thinking that it would reduce their risk of heart attack in the future. But we have now begun to see increased harms and adverse effects related to this intervention.

Dr. Gilman said that there are several ways to approach a problem like this. In the first approach, everyone gets a treatment (For example, everyone gets dietary counseling). In the second approach, everyone is screened, but only those who test positive are treated. Finally, another approach is to selectively screen people who are at high risk, and then treat only those who test as positive.

Dr. Gilman’s personal opinion is that raising– and not lowering– cut-points is the way to go in situations like this.

Back to the evidence– Hillier et al.’s 2007 observational study found that treatment of GDM may decrease body mass index in the next generation. But we really need a high-quality randomized, controlled trial with long-term follow-up of the offspring. The ACHOIS trial did follow-up the offspring from their study by linking their study data with public health  records of body height/weight at ages 4-5 years old. When they followed up on these children, they saw no effect of the intervention on body mass index. If anything, the treatment group had a higher body mass index and more children with body mass index’s above the 85th percentile.

Why would you see no effect of the treatment on BMI in offspring? It’s possible that there is a latent period between ages 1 and 4 where you would not see a weight gain that was related to maternal gestational diabetes. It could be that GDM effects weight in early infancy and in later childhood, but not in early childhood.

In summary, 2 major randomized controlled trials of mild-moderate GDM have broad agreement on benefits/risks for newborns. But treatment for GDM does not appear to reduce offspring obesity at ages 4-5 years (data from only 1 trial).

___________________________________________________________________________

Harms of Treatment of Gestational Diabetes Mellitus and Relationship to Diagnostic Threshold
Presented by Lois E. Donovan, MD, FRCPC
Clinical Associate Professor and Medical Director, Diabetes in Pregnancy
Division of Endocrinology and Metabolism
Department of Obstetrics and Gynecology
University of Calgary
Alberta Health Services

Also presented by Lisa Hartling, PhD
Assistant Professor
Department of Pediatrics
Director, University of Alberta Evidence-based Practice Centre
Alberta Research Centre for Health Evidence
University of Alberta

In their systematic review and meta-analysis, Dr. Donovan and Dr. Hartling looked for evidence of harms of treatment for GDM by combining studies together. The ACHOIS and MFMU trials were the main trials that contributed to the findings.

When the researchers compared women who received treatment with GDM to those who received no treatment:

  • There was no statistically significant difference in C-sections
  • The C-section rate was 29% overall
  • Inductions were higher in the treatment group
  • Women treated for GDM had more prenatal visits
  • There were no differences in anxiety, but there was less postpartum depression in the treatment group (1 study)
  • There were no differences in small for gestational age between groups.
  • There were no differences in NICU admissions between groups.
  • There was no increased risk of neonatal hypoglycemia with treatment

Other potential harms were not examined or reported.

___________________________________________________________________________

Harms of Treatment of Gestational Diabetes Mellitus and Relationship to Diagnostic Threshold
Presented by Timothy Cundy, MD
Professor of Medicine
Faculty of Medical and Health Sciences
The University of Auckland

Women who are diagnosed with gestational diabetes are made up of a wide range of women with unrecognized type II Diabetes, women with pre-diabetes, and women who just happen to fall into the upper end of normal. So the debate is, how many of these close-to-normal women should we include? Where should the cut-off be?

By changing the diagnostic cut-off point, this would increase the number of women diagnosed with GDM by two- or three-fold.

Dr. Cundy stated that fetal risks in gestational diabetes are largely restricted to women at the top of the pyramid who have undiagnosed Type II diabetes. With women who happen to fall into the the close-to-normal range, many of these fetal risks just do not apply (Cundy et al., 2000; Farrell et al., 2002). By definition, the new women who will be told they have a diagnosis of GDM (based on the new diagnostic criteria) will fall into that low-risk range.

Potential benefits:

  • Decreased pregnancy hypertension and (?) C-section rate
  • Decreased fetal weight gain and shoulder dystocia
  • Could we decrease development of Type II diabetes in the mother and child? No evidence for this yet.
  • Although we can decrease fetal weight gain, there is no evidence to support that treatment will reduce obesity in offspring

Potential harms:

  • Increased intervention (more prenatal visits, more inductions of labor)
  • Increased tendency to perform a C-section (Donovan et al. 2012)
  • Once we apply the label of GDM, it will affect how a woman’s pregnancy is managed by her care provider
  • If we cannot lower the C-section rate with this new criteria, lowering the diagnostic threshold will NOT be cost-effective
  • With the sky-rocketing C-section rates in the U.S., there has been huge pressure to perform C-sections. It is difficult to see that diagnosing more women with GDM will lower the C-section rate
  • If this does increase the C-section rate, what about the short- and long-term risks related to repeat C-sections?
  • Medicalization of pregnancy: A diagnosis of GDM transforms a normal life event into a disease process, focuses the source of a problem on the individual rather than the environment, and calls for individual medical intervention rather than collective or social solutions. It’s important to note that pregnancy is a time when women are particularly sensitive to their health and they are vulnerable to stress, anxiety, and guilt.
  • Preventive medical interventions in asymptomatic pregnant women should be based on the HIGHEST level of medical evidence, and we don’t have this yet for lowering the GDM diagnostic threshold.
  • This is going to cost a whole lot! Resources will have to be diverted from somewhere else. Where will these resources come from?

 ____________________________________________________________________________

Economic Implications of Altering Gestational Diabetes Mellitus Diagnostic Criteria
Presented by Aaron B. Caughey, MD, PhD, MPP, MPH
Professor and Chair
Department of Obstetrics and Gynecology
Oregon Health & Science University

Dr. Caughey spoke about the economics related to lowering the cut-off for GDM. There are 4 types of cost analysis:

  • Cost analysis = figure out the cost of doing something
  • Cost-benefit analysis = compare costs of one program to costs of another
  • Cost-effectiveness analysis = cost divided by health achieved
  • Cost-utility analysis = cost divided by quality-adjusted life years (QALY)

So what is the cost of GDM? Well there are things like:

  • Counseling sessions
  • Laboratory tests
  • Patients’ time
  • Medical therapy
  • Transportation
  • Downstream costs

Whose perspectives matters? Who bears the costs?

  • Society
  • Patient
  • Payor (Insurance)
  • Healthcare provider

There was 1 randomized, controlled trial to minimize the costs of GDM (Meltzser et al., 2010). The greatest costs were in the group who had a 75 gram test. The other 2 approaches (screen with 50 gram first, then do a 2-3 hour test) were cheaper. This finding was replicated by several other researchers, who found that the single diagnostic test was more expensive.

Is it worth it? (Is it cost-effective?) Should we be spending this money? Will we get a return our investment?

Resource allocation is a reality in health care. Spending money on one intervention will decrease money that we could have spent elsewhere. We don’t like to spend money on treatments that barely work. We like to use healthcare dollars to do the most good. Efficient use of healthcare resources saves lives and improves health.

Should we treat the patients with only one evaluated value?

Well, it does seem that it is marginally cost-effective to treat GDM according to U.S. standards– it costs about $20,000 per quality-adjusted life year. It’s important to note that in the United Kingdom, this would not be considered cost-effective. Also, the evidence showing that treating GDM is marginally cost-effective was based on an assumption that there are maternal benefits to being diagnosed, that women will benefit from this downstream. What if they don’t?

If you assume that there is no downstream benefit, then research shows that lowering the cut-off for GDM is NOT cost-effective.

So should we treat all these extra women?

If a move is made toward the new cut-off, who will be taking care of these women? Dr. Caughey found a few people who are already doing this– at Stanford and in Boston. But nobody would give him any data. Luckily, at Oregon Health Sciences University where Dr. Caughey works, they convened a panel to see if they could move forward with lowering the cut-off. This decision was made in large part because they felt that these women would benefit from nutritional counseling that could only be reimbursed with a diagnosis of GDM.

Using the new screening tests, this doubled the number of women with GDM at Dr. Caughey’s university from 5.6% to 11.7% over the course of a year. Translated to the U.S., this means 238,670 new cases per year, which would cost about $120 million/year to treat all these new patients (this is a low estimate).

In summary, some evidence suggests using the new diagnostic criteria may be marginally cost-effective, but we need to examine the assumptions of these researchers closely (for example, we can’t assume that lowering the cut-off will lower the C-section rate).

____________________________________________________________________________

Practice Implications of Altering Gestational Diabetes Mellitus Diagnostic Criteria
Presented by William H. Barth, Jr., MD
Chief, Division of Maternal Fetal Medicine
Obstetrics and Gynecology Service
Massachusetts General Hospital
Associate Professor of Obstetrics, Gynecology and Reproductive Biology
Harvard Medical School

Dr. Barth talked about the practical implications of lowering the GDM cut-off. He noted first that timing of the day matters because the test results are different at different times of day. It’s estimated that switching to the new diagnostic test would increase GDM laboratory workload by about 50%.

The new cut-off would affect different parts of the U.S. differently. Some geographic areas will be impacted more than others.

Dr. Barth then described what prenatal care looks like with and without GDM.

The typical pregnancy without GDM:

  • Prenatal visits
  • Fetal testing

The typical pregnancy with GDM:

  • Prenatal visits PLUS additional prenatal visits
  • Nutritional counseling with a dietician
  • Blood glucose monitoring
  • Insulin teaching (~20%)
  • Fetal testing PLUS additional fetal testing

So assuming about 4 million births per year and an increase in GDM to 18%, we would see:

  • +500,000 more patient education visits
  • +1,000,000 more prenatal visits
  • +1,000,000-3,000,000 more prenatal testing visits

What would happen during labor and delivery?

Both the ACHOIS and the MFMU clinical trials had conflicting findings related to inductions and C-sections. It’s possible that these women would see about a 30-40% increase in the induction of labor.

In Dr. Barth’s opinion, when a patient’s glucose test results are discussed during report in the labor and delivery unit, this has an unavoidable influence on human decision making. Even if the patient tested negative for GDM, if the clinicians know that the patients had a positive 50 gram test– this will influence their decision making. This is because one of the clinician’s greatest fears is shoulder dystocia, and care providers are very aware of the data showing an increase in shoulder dystocia in these women. 

Dr. Barth  talked about the results from the Naylor study (1996). The researchers concluded “diagnosis of GDM itself shifts obstetrical practice style toward cesarean delivery– a hypothesis motivated by evidence that operator discretion is an important and reversible determinant of cesarean delivery.”

In summary, unless accompanied by significant changes in the way we care for patients with GDM, the dramatic increase in numbers of women with GDM will have major implications. It could result in significant increases in clinic visits, prenatal testing, induction of labor, and possibly C-section. If we could somehow limit our number of interventions that we perform on these women, then the lowering of the cut-off could be effective. The only way we can know if this is possible is to conduct appropriately blinded trials, where clinicians are told the patients have GDM or NO GDM.

_____________________________________________________________________________

 

Posted in: Evidence based practice, Gestational diabetes

Leave a Comment: (0) →

Announcement: My First Research Study on Maternity Care!

I am excited to announce that I am conducting my first research study on maternity care. This past semester, several students have been working with me on a special project. Kara and Sarah are seniors in nursing who are doing an internship with me. Together, we decided that we wanted to find out how people use social media to find and spread evidence-based information about birth. Nobody has ever done a research study on this before, so very little is known about this topic.

Our research question was: How do people find, use, and spread information about evidence-based maternity care? We decided to use an internet-based survey to answer our research question.

The research study consists of a brief, 10-minute survey that you can fill out online. Anyone can fill out the survey, as long as you are 18 years or older and have accessed maternity care information on the web.

Please consider taking the survey and sharing the link with your friends! By participating in this research study, you will help us learn how people find information about evidence-based birth.

You can access the survey here. Thanks for your consideration and support,

Rebecca, Kara, and Sarah

https://www.surveymonkey.com/s/JTZNB30018

 

Posted in: Evidence based practice

Leave a Comment: (0) →

Evidence Based Birth Tutorial

Every day, I get emails from people all over the world asking me, “What’s the evidence for this?” or “What’s the evidence for that?” Today I have published a brief video tutorial that teaches you how to look up some of the evidence on your own. I use the example of eating and drinking during labor to show you how you can find evidence on the Cochrane Collaboration’s website.

Enjoy!

Posted in: Cochrane review, Eating and drinking during labor

Leave a Comment: (2) →

The Evidence for Birth Centers

The Evidence for Birth Centers

I am happy to announce that on behalf of the American Association of Birth Centers, I have written a blog article about the current evidence for birth centers. (Click here to read the full blog article).

New evidence confirms birth centers are safe. Credit: eyeliam

New evidence confirms birth centers are safe. Credit: eyeliam

I was invited to write this article to help explain the results of the National Birth Center Study II, a new, landmark study describing outcomes for more than 15,000 women who planned to give birth in 79 different birth centers in the U.S. The study was published today, January 31st, 2013, in the Journal of Midwifery and Women’s Health (click here for the full-text link to the article).

The results for birth centers?

A C-section rate of 6%, an urgent transfer rate of less than 2%, and infant outcomes similar to what other researchers have reported in low-risk populations. As I wrote:

“If the 15,574 women who planned to give birth in birth centers had instead chosen hospital births, it is estimated that they would have experienced 3,000 additional—and unnecessary— Cesareans. Instead, these C-sections were safely and effectively prevented, along with a potential cost-savings of at least $4.5 million.”

Why are these findings so newsworthy?

“The U.S. Cesarean rate has increased substantially over the past few decades from 21% in 1996 to 32% of all births now. Over half of the increase is among first time moms, and most of these C-sections are done for more subjective reasons such as slow progress in labor. Meanwhile the Cesarean rate has been stable in birth centers for over 20 years at 4.4 to 6%”

To read more about the study and what it means for families, click here to read the article.

Posted in: Birth centers, Evidence based practice

Leave a Comment: (10) →

The Joint Commission Requires Evidence-Based Perinatal Measures

The Joint Commission Requires Evidence-Based Perinatal Measures

Last December, I announced on my Facebook page that the Joint Commission had decided to make their perinatal core measures mandatory for U.S. hospitals with more than 1,100 births per year– starting in January 2014. This means that hospitals have to publicly report and evaluate their first-time mom C-section rates in order to stay accredited and stay in business.

the doctor lifting my daughter out of my belly and is just about to slide her up on my abdomen under the surgical sheet (another doctor is seen lifting the sheet up).

Do you know about the perinatal core measure requirement coming in 2014?

My announcement was  immediately met with a flurry of comments– mostly positive, but some negative. It seemed like on the whole, most people were glad to see that the Joint Commission decided to put some pressure on hospitals to reverse the rising C-section rate. On the other hand, some people were worried that this new requirement might mean that women who need C-sections would be at risk for not getting them.

I had quite a few questions myself. What do these requirements mean for women and families? Would failing to decrease their C-section rate really put a hospital  out of business? Since I couldn’t figure these things out from reading the Joint Commission’s perinatal measure set, I contacted the Joint Commission directly and asked for an interview with Celeste G. Milton MPH, BSN, RN, the project lead for the perinatal core measure set.

I wrote about my findings at ImprovingBirth.org. Click here to read what I found out! The answers may surprise you.

After reading the article, I would love to hear from you: Does your local hospital have more than 1,100 births per year and fall under the new requirements? Also, are hospital administrators and care providers in your area aware of the big changes coming in 2014?

To read the full description and rationale for the perinatal core measures, click here (Click PC-01, 02, 03, 04, or 05 to see each of the 5 measures). To specifically view the C-section measure, click here.

Posted in: C-section

Leave a Comment: (2) →

Can Hospitals Keep Moms and Babies Together after a Cesarean?

Can Hospitals Keep Moms and Babies Together after a Cesarean?

© by Rebecca Dekker, PhD, RN, APRN of www.evidencebasedbirth.com

In my previous article on skin-to-skin care after a C-section, I wrote that skin-to-skin care after a C-section has many benefits for moms and babies. However, I have come to realize that women cannot do early skin-to-skin if they are routinely separated from their babies after a C-section. In order to do early skin-to-skin, women and newborns must stay together—a process known as “couplet care.” However, the vast majority of women are separated from their babies after a C-section.

Why don’t more women and babies receive couplet care? Is it possible for hospitals to make the switch from routine separation to routine couplet care after a Cesarean? Keep reading to find out.

What is the history of mother-infant separation after birth?

Separation of human mothers and newborns is unique to the 20-21st centuries and has been a complete break from natural human history. In the past, infant survival depended upon close and virtually continuous mother-newborn contact.

The practice of routinely separating mothers and newborns started around 1900. At the time, most women received general anesthesia that made them and their babies incapable of interaction after birth. Because mothers couldn’t care for their babies, hospitals created central nurseries to care for newborns, and infants were typically separated from their mothers for 24-48 hours. Separation from parents was also meant to ”protect” infants from maternal illnesses (Anderson, Radjenovic et al. 2004).

In her book Hypnobirthing, Marie Mongan described her experience of being separated from her infant in the 1950′s…

My head was held as the ether cone was forced onto my face. That was the last I remembered. I awakened sometime later, violently ill from the ether, and was informed that I had “delivered” a beautiful baby boy, whom I would be able to see in the morning…. My husband saw our son only through the window of the nursery for the next five days, as no one was allowed to visit when “the babies are on the floor.” Our family bonding was nonexistent.

When did things begin to change?

In 1961, Dr. Brazelton published a classic study showing that general anesthesia was harmful to newborns (Brazelton 1961). As a result of his research, more people began to move away from using general anesthesia during birth, which resulted in mothers and infants being more alert—and capable of interaction—immediately after birth (Anderson, Radjenovic et al. 2004). In addition, most mothers who give birth by Cesarean receive regional anesthesia instead of general anesthesia, so these mothers, too, are usually alert after giving birth.

Furthermore, in the past 30 years, an abundance of research evidence has shown that when mothers and babies are kept close and skin-to-skin after birth, outcomes improve (Moore, Anderson et al. 2012).

It is very important for you to understand that when researchers study human mother-newborn contact, keeping mothers and babies together is always considered the “experimental” intervention. In contrast, when researchers study other non-human mammals, keeping mothers and babies together is the control condition, while separating newborns from their mothers is “experimental” (Moore, Anderson et al. 2012).

What is routine practice today?

Although most mothers now are capable of taking care of their babies after birth, and despite the fact that research overwhelmingly supports couplet care—hospital practices have been very slow to change.

Routine separation of moms and babies during the recovery period still happens at 37% of vaginal births in the U.S., with rates ranging widely from state to state. In Alaska, only 5% of babies are separated from their mothers after a vaginal birth, while in Mississippi, 81% of infants are separated from their mothers after a vaginal birth. (Centers for Disease Control, 2010)

After most C-sections, babies are sent to the nursery for routine careCredit: brettneilson

After most C-sections, babies are sent to the nursery for routine care
Credit: brettneilson

How often are women separated from their infants after a C-section?

Separation of mothers and infants is very common after a surgical birth or C-section. In the U.S.,  86% of women who give birth by C-section are separated from their babies for at least the first hour (Declercq, Sakala et al. 2007). With more than one-third of U.S. women now giving birth by Cesarean, this means that a substantial proportion of mothers and babies experience a critical delay in bonding, skin-to-skin contact, and breastfeeding.

Research shows that most of the time when babies are separated from their mothers after a C-section it is so that the hospital can provide routine mother/baby care in separate rooms—not because the babies need any kind of special care (Declercq, Sakala et al. 2007). When infants are brought to the nursery while their mothers recover separately, it is common for a nurse to give a first feeding of formula (Elliott-Carter and Harper 2012).

What are the benefits to keeping moms and babies together?

To read the benefits of keeping moms and babies together, please refer to my article on skin to skin care after a Cesarean. To summarize, babies who receive couplet care—in other words, who stay with their mothers and receive early skin-to-skin care—are 2 times more likely to be exclusively breastfeeding at 3-6 months, compared to babies who receive routine hospital care. You can read about the many other benefits of early skin-to-skin care—and the potential harms of separating mothers and babies— here.

Submitted by an anonymous reader. Dads can do skin-to-skin care, too. Everyone can stay together.

Submitted by an anonymous reader. Dads can do skin-to-skin care, too. Everyone can stay together.

Are there any potential harms to keeping moms and babies together after a C-section?

It is important to know that some mothers may not capable of independently caring for their infants immediately or for several hours after a C-section. For example, if mothers received strong sedatives, are nauseous, or were sleep-deprived for many hours before the Cesarean, then they may need supervision or assistance in caring for their newborns.  The mother’s level of awareness and her ability to remain awake when caring for and feeding infants must be assessed and closely monitored by nursing staff, especially when a Cesarean follows a prolonged labor or when sedative drugs have been given (Mahlmeister 2005). In this case, then the father or partner can do skin-to-skin with the infant.

Is it possible for hospitals to keep moms and babies together after a Cesarean?

Yes, it is possible for hospitals to keep moms and babies together after a Cesarean. Two different hospitals have published quality improvement reports describing how they switched from routine separation to routine couplet care after C-sections (Spradlin 2009; Elliott-Carter and Harper 2012).  As both reports were very similar, I will focus on the most recent article by Elliott-Carter (you can read the article for free in its entirety here).

Why did this hospital decide to make the change?

In 2011, nurses at Woman’s Hospital in Baton Rouge, Louisiana, led a switch from routine separation after Cesareans to couplet care—keeping moms and babies together. The hospital was motivated to change for several reasons, including a desire to stay competitive with other hospitals and repeated requests from patients to not be separated from their babies.  

Perhaps most compelling, the staff felt it was simply “not fair” that moms who gave birth vaginally were allowed to stay with their babies, while moms who had C-sections were automatically separated from their babies. The C-section rate at Woman’s hospital was 40%, and they have more than 8,000 births per year. So making this change affected 3,200 families per year.

How did the hospital change to couplet care?

Amy and her baby Kareanna stayed together after a Cesarean-- which allowed them to do very early skin-to-skin care.

Amy and her baby Kareanna stayed together after a Cesarean– which allowed them to do very early skin-to-skin care.

One of the first things the hospital did was put together a leadership team to plan for the change. This team included nurse managers from labor and delivery, postpartum, and newborn care, as well as pharmacists and materials management. The team communicated the plan to other groups (such as medicine). One of the team’s challenges was finding a large enough space where moms and babies could recover together after a C-section. They ended up choosing overflow labor and delivery suites that were big enough to accommodate the couplet. They also modified the existing recovery room (PACU) so that it could be used in case the overflow rooms were full. They moved curtains to make each patient’s space big enough for both mothers and infants to recover together, and they put a radiant warmer for the infant in each recovery space.

The team had to make several other small changes. They had to train the recovery (PACU) nurses in neonatal resuscitation. They made sure baby blankets were placed in the heated blanket warmer, and that appropriate medications for both moms and babies were stocked in each room.

Perhaps most importantly, staff made a commitment to provide care where the mothers and babies were, instead of always taking the baby away to the nursery. Although taking the baby to the nursery was easier and more convenient for the staff, they realized that keeping the couplet together was best for moms and babies. It took about 6 weeks from the beginning of this process until couplet care was fully implemented.

How did it go for this hospital in Louisiana?

In the first year after starting couplet care, the percentage of infants who were separated from their mothers dropped from 42% to 4%. Nurses stated that everyone was extremely satisfied with the change—including staff, physicians, and mothers. Nurses report that mothers are able to have skin-to-skin contact earlier, and that the first breastfeeding session goes smoother. Inspired by the bonding they witnessed between moms and babies, nurses decided to delay administration of erythromycin ointment and the vitamin K shot until after the initial breastfeeding. As nurses from the Woman’s Hospital said,

“If a hospital that delivers 8,000 infants annually can find a way to decrease the separation of mothers and newborns, concerned nurses everywhere should be able to implement this type of care.”

In the ideal situation, mom does skin-to-skin in the operating room. The family is never separated during recovery.

In the ideal situation, mom does skin-to-skin in the operating room. The family is never separated during recovery.

So what is the bottom line?

Evidence has shown that it is possible—and best practice—for moms and babies to stay together after a Cesarean.

If a hospital staff member tells a mother that it is “impossible” for her to stay with her baby after a C-section, that statement is false. Making the switch from routine separation to couplet care can be done—some hospitals have already done so. Although couplet care may be more inconvenient for staff in the beginning, in the end, keeping mothers and babies together after a Cesarean is what is best.

Mothers who want to do very early skin-to-skin care and interact with their babies after a C-section should talk with their providers about this mother-friendly and baby-friendly practice. Moms should also talk with their anesthesiologists to make sure that they do not receive sedative drugs unless medically necessary, as these drugs may make some women incapable of early interaction with their newborns.

If you want to read more medical research:

If you liked this article, you may be interested in:

References:

  1. Anderson, G. C., D. Radjenovic, et al. (2004). “Development of an observational instrument to measure mother-infant separation post birth.” J Nurs Meas 12(3): 215-234.
  2. Brazelton, T. B. (1961). “Effects of maternal medication on the neonate and his behavior ” Journal of Pediatrics 58: 513-518.
  3. Centers for Disease Control (2010). Maternity Care Practices Survey. Accessed online January 5, 2013.
  4. Declercq, E. R., C. Sakala, et al. (2007). “Listening to Mothers II: Report of the Second National U.S. Survey of Women’s Childbearing Experiences: Conducted January-February 2006 for Childbirth Connection by Harris Interactive(R) in partnership with Lamaze International.” J Perinat Educ 16(4): 9-14.
  5. Elliott-Carter, N. and J. Harper (2012). “Keeping mothers and newborns together after cesarean: how one hospital made the change.” Nursing for Women’s Health 16(4): 290-295.
  6. Mahlmeister, L. R. (2005). “Couplet care after cesarean delivery: creating a safe environment for mother and baby.” J Perinat Neonatal Nurs 19(3): 212-214.
  7. Moore, E. R., G. C. Anderson, et al. (2012). “Early skin-to-skin contact for mothers and their healthy newborn infants.” Cochrane Database Syst Rev 5: CD003519.
  8. Spradlin, L. R. (2009). “Implementation of a couplet care program for families after a cesarean birth.” AORN J 89(3): 553-555, 558-562.

 

Posted in: C-section, Evidence based practice, Skin-to-Skin

Leave a Comment: (5) →

Frequently Asked Questions… that Other People have Already Answered!

Here at www.EvidenceBasedBirth.com and on my Facebook page, I receive many questions about the evidence for various labor and delivery practices. Unfortunately, due to my busy life as a professor and a mother of two, I don’t have time to write all the evidence-based articles that I would like. So that’s why I love to point people to evidence-based blog articles that other people have already written. Here are a few of my favorites!

Disclaimer: I agree with most, but not all, of the points listed in these articles. I probably would have written my articles in a slightly different style. But with that being said, I think these are reliable sources and that the authors cover the available research pretty thoroughly. 

Q: What is the evidence for delayed cord clamping?

A: Nicholas Fogelson (the Academic OB/GYN) has a series of articles on delayed cord clamping. You can read his original article here, a follow-up article here, and if you have time you can watch his grand rounds lecture on YouTube here. To sum it all up, delayed cord clamping has many benefits for both pre-term and term infants, although it does lead to a higher risk of jaundice. (The higher risk of jaundice is not surprising, really, since the breakdown of red blood cells contributes to jaundice, and infants who have delayed cord clamping have more red blood cells).

What does the evidence say about the timing of cord clamping? Credit: dsyzdek

What does the evidence say about the timing of cord clamping? Credit: dsyzdek

Q: My doctor says that my baby has to stay lower than my placenta if I want delayed cord clamping. Is this true?

A: Dr. Mark Sloan (a pediatrician) has written an article about this and other controversies related to delayed cord clamping here. The short answer? No, the baby does not have to stay below the level of the placenta while the cord is still intact; it is perfectly fine for the baby to be in your arms!

Q: Is evening primrose oil safe to use during pregnancy?

A: Jen Kamel of VBACFacts.com looked at the very little research available on evening primrose oil and summarized the evidence here. Her conclusions? There is no evidence showing that evening primrose oil (EPO) is safe during pregnancy, and there may be potential harms.

Q: What is the evidence for letting the placenta come out on its own time versus giving Pitocin and putting traction on the cord?

A: Midwife Thinking wrote an interesting article about the evidence on this topic here, explaining why the evidence suggests that “active management” (giving Pitocin and putting traction on the cord) may be more beneficial for most women who give birth in hospital settings. (To understand why I highlighted those two words— “most” and “hospital”—read the article!). 

Q: Can you lead me to evidence-based research or randomized double-blind studies regarding placenta encapsulation?

A: As far as I can tell, no research on this subject exists!  Unfortunately, I can’t help you evaluate the research evidence if there is none to be had.

Q: I’m looking for information on epidurals. Can you help?

A: It’s not a blog article, but there is a great evidence-based resource about epidurals on Childbirth Connection’s website, which you can read here. The take-home point? Epidurals are highly effective at relieving pain but also carry many potential harms.

What are the potential benefits and risks of an epidural? Photo credit: beglen

What are the potential benefits and risks of an epidural?
Photo credit: beglen

Q: Is suspected “big baby” a valid medical reason for an induction or C-section?

A: Jill Arnold from the Unnecesarean has written extensively about the research on this topic. You can see a list of her “big baby” articles here, or you can just check out this one (my favorite). Want the quick answer? Current evidence does not support early induction of labor for suspected big babies. Induction of labor doubles the risk of cesarean delivery without reducing the risk of shoulder dystocia or newborn morbidity. The same could be said for elective C-section for a suspected big baby—this practice is not supported by evidence.

Q: Was my Cesarean for “failure to progress” really necessary?

A: It would be inappropriate for me to listen to your story and tell you whether or not your C-section was necessary. However, research has shown that “failure to progress,” also known as labor dystocia, is a common cause of preventable C-sections. In fact, a substantial number of un-planned C-sections are due to “failure to progress,” and research shows that almost all of the time these diagnoses were made prematurely. The Well-Rounded Mama talks about how a woman’s failure to progress is frequently just the care provider’s “failure to wait”—especially when it comes to larger women.  You can read her evidence-based article here.

What are your favorite evidence-based articles? Please feel free to link to them!

Warning: comments with 3 or more links are usually sent to my spam folder, so please limit yourself to 2 links per comment.

If you liked this article, you may also be interested in:

Is erythromycin ointment always necessary for newborns?

What kind of fetal monitoring is based on evidence?

 

Does gestational diabetes always mean a big baby and induction?

Posted in: Evidence based practice

Leave a Comment: (11) →
Page 1 of 7 12345...»