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In this episode we are continuing our series on protecting the perineum by talking about the evidence on whether prenatal perineal massage is effective at preventing perineal tears during childbirth. We’ll also discuss the importance of critically analyzing research, and what “predatory open access publishing” has to do with some of the research on perineal massage! Head’s up… if you haven’t listened to EBB Episode 206 yet, I recommend listening to that episode first, since it covers introductory information about perineal tears.
 
Content warning: Discussion of perineal tears during childbirth, severe tears, obstetric violence, and episiotomy.

Resources

·      Check out Episode 206 of the EBB Podcast to learn about Perineal Tears and Avoiding Episiotomy and Episode 210 to learn about warm compresses and hands on vs. hands off techniques
·      Go to our YouTube channel to see video versions of all our podcasts!
·      Visit https://evidencebasedbirth.com/childbirth-class/  to learn more about the Evidence Based Birth  Childbirth Class
·      Take a continuing education class on this topic (and earn a contact hour) by joining the EBB Professional Membership  here: https://evidencebasedbirth.com/become-pro-member/
·      Check open access journals to see if they are on beallslist.net (https://beallslist.net/standalone-journals/) as a potential predatory journal.
·      Resource for authors to determine whether they should submit to an open access journal: https://thinkchecksubmit.org/

Perineal Massage Research: 

·      Abdelhakim, A. M., Eldesouky, E., Elmagd, I. A., et al. (2020). Antenatal perineal massage benefits in reducing perineal trauma and postpartum morbidities: a systematic review and meta-analysis of randomized, controlled trials. International Urogynecol J. https://doi.org/10.1007/s00192-020-04302-8
·      Ali, H. A. E. (2015). Effects of prenatal perineal massage and Kegel exercise on the episiotomy rate. IOSR J Nurs Health Science 4(4)3:61-70. https://www.iosrjournals.org/iosr-jnhs/papers/vol4-issue4/Version-7/H04476170.pdf
·      Labrecque, M., Eason, E., Marcoux, S., et al. (1999). Randomized controlled trial of prevention of perineal trauma by perineal massage during pregnancy. Am J Obstet Gynecol 180:593-600. https://pubmed.ncbi.nlm.nih.gov/10649159/
·      Dönmez, S., Kavlak, O. (2015). Effects of prenatal perineal massage and kegel exercises on the integrity of postnatal perine. Health: Scientific Research Publishing. Published online https://www.scirp.org/pdf/Health_2015042716331294.pdf
·      Dieb, A. S., SHoab, A. Y., Nabil, H., et al. (2019). Perineal massage and training reduce perineal trauma in pregnant women older than 35 years: a randomized controlled trial. International Urogynecol J. https://doi.org/10/1007/s00192-019-03937-6
·      Beckmann, M. M., Stock, O. M. (2013). Antentatal perineal massage for reducing perineal trauma. Cochrane Data Syst Rev. Issue 4, No: CD005123.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD005123.pub3/full
 
Information on Predatory Journals:

·      Sharma, H., Verma, S. (2018). Predatory journal: The rise of worthless biomedical science. J Postgrad Med 64(4): 226-231. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6198688/   
·       Shamseer, L., Moher, D., Maduekwe, O., et al. (2017). Potential predatory and legitimate biomedical journals: can you tell the difference? A cross-sectional comparison. BMC Medicine 15: 28.  https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-017-0785-9
·      Check open access journals to see if they are on beallslist.net (https://beallslist.net/standalone-journals/) as a potential predatory journal.
·      Resource for authors to determine whether they should submit to an open access journal: https://thinkchecksubmit.org/

Transcript

Rebecca Dekker:

Hi, everyone. On today’s podcast, we’re going to talk about the evidence on prenatal perineal massage, and whether or not it’s effective at preventing perineal tears during childbirth. 

Welcome to the Evidence Based Birth® Podcast. My name is Rebecca Dekker, and I’m a nurse with my PhD and the founder of Evidence Based Birth. Join me each week as we work together to get evidence-based information into the hands of families and professionals around the world. As a reminder, this information is not medical advice. See ebbirth.com/disclaimer for more details.

Hi, everyone, and welcome to today’s episode of the Evidence Based Birth® Podcast. My name is Dr. Rebecca Dekker, pronouns she, her, and I will be your teacher for today’s episode. Today I’m so excited to bring you more evidence-based information to you about perineal tears, and some research on a method that is sometimes used with the intent of preventing perineal tears, and that is perineal massage during pregnancy. Before we get started, I wanted to let you know that we will be talking about some topics including tears, severe tears from the vagina to the rectum, obstetric violence, and episiotomies. Today’s episode is a third in a series we’re doing this year called “Protecting the Perineum.”

In the first episode, which was episode 206 of the EBB Podcast, I talked with you about what are perineal tears, what are the factors that can increase your risk of having a tear during childbirth, the health consequences of tears, and why it’s so important to avoid an episiotomy. In the second episode of the series, in episode 210, I talked about warm compresses and the hands-on versus hands-off techniques for preventing tears. If you haven’t listened to those episodes already or watched them on YouTube, I’d encourage you go back and listen before moving forward, especially to the 206 episode, because each episode is going to build on the one right before it.

Also, you might be listening to this episode on a podcasting app, but I also wanted to let you know that there is a video of this episode on our YouTube channel at Evidence Based Birth. If you’re more of a visual learner, I encourage you to visit and subscribe to the EBB YouTube channel today. Also, before we get started, I want to quickly define what the perineum is. The perineum is a diamond-shaped area that’s between the thighs, and in birthing people, it’s going to be the area between your symphysis pubis or the front of the pelvis and the rectum at the back. When we’re talking about protecting the perineum, we’re talking about protecting that tissue, and in particular, protecting the tissue that makes the space between the vagina and the rectum.

Perineal tears, or tears of the perineum, that can happen during childbirth can be rated as first degree, second, third or fourth degree. A first degree would be the least severe and a fourth degree would be the most severe. The most important thing that birthing people want to do is lower the risk of severe tears, or third or fourth degree tears, sometimes called OAC tears, because they can have severe health consequences. In episode 206, we talked about factors that can decrease or increase your risk of a third or fourth degree tear and the importance of avoiding an episiotomy.

A lot of the time when we’re looking at practices, we’re looking to see if they’re effective for helping you avoid a third or fourth degree tear or a severe tear, and if they’re effective at helping you avoid an episiotomy, because that’s one of the strongest risk factors for developing a third or fourth degree tear. We’ve also looked at the effectiveness of leaving birth with an intact perineum, which means that you leave the birth without needing any stitches, which is the ideal situation for someone who gave birth to their baby vaginally. We’ve had a lot of questions about perineal massage, both perineal massage during pregnancy and perineal massage during labor and birth.

At first, I was going to combine those two topics into one episode, but the more I dug into the research, the more I realized we really need to separate it out. This episode is going to focus on perineal massage towards the end of pregnancy, and the next month we’ll do another episode about perineal massage during labor. Perineal massage during pregnancy is typically done by the pregnant person or their partner. That’s in contrast to perineal massage during labor, which is usually done by the healthcare worker. During pregnancy, perineal massage is often done with the intent to increase tissue elasticity, and it’s usually started at around 34 to 35 weeks. Anywhere from about a month to a month and a half before your due date. And

With perineal massage, typically educators will teach that you insert one to two fingers about two inches into the vagina and apply pressure downward for two minutes, then sideway for two minutes, in a U-shaped motion, and often it’s encouraged to use some kind of safe lubricant for that. Simple protocols for a perineal massage during pregnancy range from telling you to do it weekly to telling you to do it three to four times a week, and some people will say for a few minutes, some people will say for up to 10 minutes. With perineal massage, some people believe that it increases blood flow to the perineum enhancing the circulation and stretching the tissues which help them widen for the baby to pass through there.

However, other people think that it may cause an opposite effect, that it may create micro tears and micro damage to the tissue making it more likely that you might tear. Which is it? We will find out in a little bit if it’s effective or not, or at least we’ll see if it’s possible to find out. I’ve also heard some birth workers say that perineal massage can be useful for someone who is a survivor of sexual assault. They believe that, with practice and using perineal massage in a safe space, that can prepare you for the sensation of the baby coming out. I have not seen any research on that, but that is something that some birth workers have told me.

It seems that most people that I’ve talked to you have at least heard of perineal massage during pregnancy. If you talk to your friends that are pregnant or birth workers, they’ll mention, “Oh, have you thought about perineal massage?” It’s often recommended among friends and among birth workers. But I really am curious, what is the evidence on this practice? Is it helpful or is it a waste of time? What is the evidence say? Since here at Evidence Based Birth, that’s what we do best, I want to dive into the research and take you on a little journey through the research studies to find out what do we actually know about this practice and its effectiveness?

One of the first things we typically do at Evidence Based Birth®when we’re reviewing the evidence on a subject is we go look at the research literature to see if there are any meta-analyses on that subject. A meta-analysis is when they take other studies and combine them into one big meta-study to see if we can combine the results and the statistics into one big study. This is often very helpful because those researchers that do the meta-analysis do a ton of work digging through all the studies to find as many studies as they can on that topic that fit their inclusion criteria, and then combining the data into one analysis. They can be very useful, but meta-analysis can also be flawed, because if they include a lot of poor quality research in their meta-analysis, then you can’t really trust the results of the meta-study.

There was an older Cochrane meta-analysis on perineal massage during pregnancy that was published by Beckmann and Stock in 2013. It had a total of four randomized control trials with about 500 participants, and we had looked at that in the past at EBB. We were excited to see that, in 2020, a group of researchers led by Abdelhakim et al. published a paper in the International Urogynecology Journal, looking at perineal massage during pregnancy. By this point, about seven years had passed since the earlier meta-analysis, and now there are more randomized trials on this subject. They were able to include 11 randomized control trials with about 3,500 pregnant people, and this is the largest, most comprehensive meta-analysis on this topic to date.

They looked at studies that compared people who were assigned randomly to perineal massage versus those who were assigned to no perineal massage during pregnancy. Out of the 11 studies, four of them took place in Egypt, one in Nigeria, one in Turkey, one in Iran, one in Japan, two studies in Canada, and one study in the United Kingdom. The studies include people who were giving birth for the first time and those who were giving birth to subsequent children. Talking about whether or not you’ve had a baby before is an important subject when you’re talking about perineal tears, because as we talked about an episode 206, giving birth for the first time puts you at a lot higher risk for tearing compared to people who’ve given birth vaginally before.

The authors of this meta-analysis said that the quality of the trials that they included ranged from moderate to high quality. However, as you’re going to find out in a little bit, I have serious concerns and questions about the author’s assessment of the quality of these studies. All the studies had in common though that they were randomly assigned some people in the study to perform perineal massage either by themself or with a partner in the last four to six weeks before they were due to give birth. Unfortunately, the authors of the meta-analysis did not report the results by whether or not you had given birth before vaginally. We don’t know if the results differ based on if you’ve had babies before or not.

They did, however, find that when they combined the results that the intervention group, that is the group that was assigned to do the perineal massage, had lower rates of episiotomy and perineal tears, especially lower rates of third and fourth degree tears, those severe OAC tears that we were talking about that we really want to prevent. They found no difference between groups and first and second degree tears, the more minor tears. They also found people who were assigned to perineal massage had better wound healing, less perineal pain, a shorter second stage or pushing phase of birth, lower rates of fecal incontinence after the birth, and surprisingly, better Apgar scores for the baby.

They concluded that perineal massage during pregnancy is associated with the lower risk of severe perineal trauma and postpartum complications. Looking more closely in at the severe tears, they found that there were about 114 severe tears in the control group out of about 1,550 people, and 55 severe tears in perineal massage group out of 1,519 people, and they said that was a relative risk reduction of 64%. Wow, those results seem to be really in favor of perineal massage. Right? Well, there were a few things that I was curious about because, first of all, the authors reported that when they did a statistical test looking for something called publication bias, they did find a significant publication bias.

A publication bias is defined as when the outcome of an experiment or research study influences the researcher’s decision to publish it or not. If they’re only publishing results that show a positive finding, this can disturb the balance of findings in a meta-analysis, and it biases the meta-analysis in favor of positive results. First of all, that’s a little bit of a red flag because what the researchers are telling us is that there was a bias in that researchers seem to be only publishing results that find a positive income with perineal massage, and they’re withholding research that showed either no change in outcome or a negative outcome.

But we don’t know exactly how big that bias is. All we know is that there is a bias, and that makes sense because having come from a research background myself, I know that when you’re really excited, you get a great finding in your research study, the finding that you were hoping for, you’re super excited to go out and publish those results. Whereas if you do a randomized trial and your finding is blah, nothing happened, there was no improvement and no difference at all, then you’re less likely to go out and publish the results and the journals are less excited to publish your results as well. The other thing that I thought was interesting is that the authors of the meta-analysis didn’t seem to critically analyze or critique any of the studies.

I knew from past experience, in looking at the 2013 Cochrane Review, that there was a very large trial in that review by Labrecque et al. that had some really interesting context, and I was interested. I was like, “Well, why didn’t these researchers look more deeply at the context of these studies?” I decided to do it for myself because they weren’t giving me a lot of information about the quality of these studies that they’d included, and I knew from past experience that some of these studies can have really interesting context. I’d started to dig back, and looking at the list of studies that they included, only seven trials out of the 11 looked at the outcome of severe tears, the third or fourth degree tears.

Four of those seemed to have numbers that were really weighted in favor of perineal massage. I said, “Well, let’s go look at these studies that found these really positive results of perineal massage and see what those studies were like. What were they actually doing? What were the methods of the study?” This is something that I, as a trained researcher and someone who went through a PhD program and used to teach PhD students, it’s really important to me to know the quality of the research that I’m talking about. A lot of times you’ll see people will just read the abstract or the summary of a study, and they’ll take that as if it’s proof that the study worked. This is what they found, so we should make this change. But I’m a little bit more skeptical than that just because I have a history in clinical research and I know it’s really important to go look at the details.

Let’s look at those together. Now, if you’re joining us on YouTube, you’ll see I have some PowerPoint slides at this point in the podcast because I want to share with you some details about these studies, and I thought it might be helpful to have a visual. The four studies that we’re going to look at are one by Labrecque et al. that was published in 1999, a study by Ali published in 2015, one by Dönmez published in 2015, and one by Dieb et al. published in 2019. Let’s look at Labrecque et al. first. This study was published in 1999, and it was also in the previous Cochrane Review. I’ve read this study before and I’m familiar with its methods and its results, but I wanted to share this one with you.

This study took place in Quebec, Canada, and in the study, they first stratified everyone by whether or not they had a prior vaginal birth. They put you into two groups, either you had a prior vaginal birth, or you did not, you were giving birth vaginally for the first time. Then both of those groups were then randomly assigned to perineal massage during pregnancy. They were instructed to massage themselves 10 minutes a day, or to a control group. There was a total of 1,527 people in this study. It was a pretty large trial. This trial had what we call a low risk of bias. It was very high quality trial, very well done. They did a great job of making sure that the doctors taking care of the patient didn’t know the study assignment.

All of the participants in this study were instructed not to reveal their group assignment to doctors and the doctors were told not to ask. That helps remove some of the bias from the healthcare provider, and that’s really important because if the healthcare provider knew which group you were in and you were in a participant in that study, that knowledge of which group you’re in might sway or swing their behavior in a certain way, depending on what that doctor believes. It’s really important to make sure that the care providers have no clue what the patients have been doing during pregnancy. At the time, episiotomy rates were still really high in Canada.

All the physicians in the study were provided with written information on the importance of avoiding episiotomy, and they were given monthly reports with their episiotomy rates in an attempt to help them keep their episiotomy rates lower. They did a really good job with random assignment. They used quality methods for randomly assigning people to groups, and they tracked adherence to the perineal massage, which is also important to know. Did the people actually do the perineal massage or not? They measured that with a daily diary. They also did a questionnaire after the birth, and there were regular calls from a research nurse.

They found that 66% of the first time birthing people who were assigned to perineal massage did complete the massage four times a week or more for three or more weeks, and more than 85% of them did at least a third of the assigned days. They had pretty good adherence to the perineal massage. Adherence was lower among people who had given birth vaginally before. They also checked to see if anyone in the control group did perineal massage and only a very small number of people in the control group did perineal massage. Both groups received education on the importance of avoiding episiotomies at the beginning of the study, and both groups at the very beginning of the study had similar motivation in terms of keeping their perineum intact.

The researchers said that the decisions about the episiotomy though were made by the resident or attending physician, implying that it was the doctor’s call whether or not to do an episiotomy. The cesarean rate in this study was around 19% to 21% in people without a prior vaginal birth, and 2% to 4% in those with a prior vaginal birth. There was actually quite a high rate of forceps or vacuum delivery among people who had not given birth previously. The forceps or vacuum delivery rate was 24%, and this is a pretty high rate of instrumental delivery. That’s important because having a vacuum or forceps can also increase your risk of severe tear.

They reported the results divided out based on whether it was your first time giving birth or you’d had a prior vaginal birth. For people who were giving birth vaginally for the first time, there was a higher rate of intact perineum in the massage group, 24.3% compared to 15.1% in the control group. There was lower rates of episiotomy, third and fourth degree tears with an episiotomy, and third and fourth degree tears without an episiotomy in the massage group. The risk of having an episiotomy was about 27% in the massage group and 31% in the control group. Just to give you some context, an ideal episiotomy rate would be less than 1%. These episiotomy rates are pretty high in both groups, but they’re slightly lower in the perineal massage group.

The rate of having a third or fourth degree tear without having an episiotomy cut was similar between groups. Only 10 people in the massage group and 12 people in the control group had a natural third or fourth degree tear. If you managed to get through the birth without an episiotomy in this study, your chances of avoiding a severe tear were pretty good in both groups. The chance having a third or fourth degree tear with an episiotomy was slightly higher in the control group, 9.6% versus 8% in the perineal massage group. Overall, these results in terms of the perineal tears and episiotomy rates were significantly different between the massage and control group, although they weren’t super heavy weighted in favor of massage.

Then when you look at the results of people who had a prior vaginal birth, there were no statistically significant results between the perineal massage group and the control group. The intact perineum rates were around 32% to 35% in both groups, and the episiotomy rates were around the 14% to 17% range. The rate of having a third or fourth degree tear without an episiotomy cut was similar between groups. About one person in each group had a natural third or fourth degree tear. The chances of avoiding a severe tear were very good in groups of people with a prior vaginal birth, regardless of whether they did the perineal massage or not. One of the things you have to keep in mind with this Labrecque et al. 1999 trial is that this study took place in a time and place where episiotomy rates and vacuum and forceps rates were very high.

They also found that perineal massage only seemed to be beneficial to people giving birth for the first time, not to people who had a prior vaginal birth, and they said in their discussion that the primary effect seemed to be through a lower rate of episiotomy and a lower sutured first degree tear rate, which was about 4% lower in the massage group. They did report, however, that satisfaction level were high and that most people in the perineal massage group, 87% to 89%, said they would recommend perineal massage to a friend. The researchers also stated that the constant attention to perineal massage may have significantly increased the massage groups’ motivation to avoid an episiotomy.

They’re not really sure if the perineal massage works because it increases tissue elasticity or because there’s a greater motivation, you’re constantly thinking about protecting your perineum and avoiding an episiotomy, so that leads you to collaborate better with your care provider to avoid perineal trauma, perhaps by working them to have a slower, more controlled birth of the baby’s head. That’s the results from the Labrecque et al. study, and it’s a very important study because it was so large, so it makes up a lot of the results of both the older Cochrane Review and the more recent meta-analysis from 2020. Now I want to go on to the other three trials that also seemed to tip the favor in the meta-analysis towards perineal massage, and this is where it gets interesting.

I’m holding here the paper I printed off by Hala Abdel Fattah Ali about the effects of prenatal perineal massage and Kegel exercise on the episiotomy rate. One of the first things I noticed about this paper is that there’s a lot of typos all over it, spaces missing between words and numbers, almost like it had been copied and pasted and not fixed, and it was difficult to read, but I looked past that and I was looking at the actual methods. One of the things that I noticed right away is that this study is a very high risk of bias. When I was looking at the methods section, they did not really do randomization. They basically said, “If you come to the clinic on Monday, you are in one group. If you come to the clinic on Tuesday, you’re in another group. If you come to the clinic on Wednesday, you’re in a third group.”

They didn’t actually do true randomization. This was not a randomized trial. Also, you can tell, but they didn’t really randomize the trial because the groups had baseline differences. There were differences between the groups. They were different in terms of age, education, whether or not they had had babies before, and more. This study had three groups, which the meta-analysis didn’t tell you about. They had a group with perineal massage during pregnancy, one where they trained you how to do Kegel exercises, and a plain old control group. Another thing I want to know about Egypt, because we have an Evidence Based Birth®instructor in Egypt, is that it’s very typical to see extremely high rates of cesarean in Egypt, anywhere from 50% to 90% cesarean rates.

Basically, anybody who doesn’t have a cesarean will have an episiotomy, and there’s a high rate of obstetric violence. Often people are not allowed to have epidurals if they’re having a vaginal birth. That’s the setting where this study is taking place. As I was digging through the study, I was shocked to see that the researcher said they knew who was in each group. There was no what we call blinding. The researcher knew which group each patient was assigned to, and the researcher did all the assessments in the intrapartum care during labor. The researcher carries their bias with them through that whole research process. That’s why it’s so important for people who are taking care of the patients to not know which group they’re assigned to.

Also, people dropped out for odd reasons. If you look at their flow chart, they said, out of the massage group, that 20 people were excluded from the perineal massage group, 10 of them because they had problem with the umbilical cord. That doesn’t even sound like a possibility. In the Kegel exercise group who had 75 people, they excluded 15, 10 of them because they were breach. There were 10 breach births in that group, but zero in the others. There were just some really odd things as I was reading this study. Also, the p-values didn’t make any sense. For those of you who don’t know what a p-value is, a p-value is one of the statistics you look at to see if the results were due to chance or not. There were things that were very different, like the induction rate was 54% in the control group and the 0% in the perineal massage group.

But the p-value said it was not statistically different. Well, that didn’t make sense to me. Then there was another section where some of the numbers were very similar, right close together, like the average newborn weight in each group, and the p-value was highly significant. I started questioning whether these numbers were real. The results seemed ridiculously unreliable and unbelievable. The results show that the perineal massage group only had one third degree tear and zero fourth degree tears out of 50 people, compared to 14 third degree tears and 13 fourth degree tears in the control group, that had 70 people? I’ve never heard of that many people having a third or fourth degree tear in any study.

Now, in that meta-analysis from 2020 that we talked about earlier, they actually excluded this study from their sensitivity analysis for a couple of their measures, but not for the severe tear measure. It was left in for a lot of the analyses. But based on my review of this study, it seems that it has a bunch of bias and possibly some fake results. The next study on my list was by Dönmez and Kavlak, published in 2015. This study was carried out in Turkey, and I noticed right away that this study also had a very high risk of bias. Like the previous study, they did not do true randomization and the groups had differences as a result. The researcher knew who was in each group and did all the assessments in the intrapartum care.

People dropped out of the study for very odd reasons, and some of the p-value didn’t make sense. Then I realized that most of the paper by Dönmez et al. was identical to the Ali paper. For example, the introduction is just cut and pasted into different sentences in different order, and they use almost word for word the exact same language. Then you look at even the tables for how they present the data are presented in the exact same order. It’s just the numbers are changed a little bit here and there. I was like, “Wait a second,” and as I started digging in here, I was like, “Oh my goodness, there’s something really wrong with this research.” In the Dönmez study, the results show that the control group had 100% episiotomy rate and 12 people out of 39, 31%, had a third or fourth degree tear.

Whereas the perineal massage group had an episiotomy rate of 83% and only two third degree tears out of 30 people, and zero fourth degree tears, for a severe tear rate of 7%. But anyways, what I began to realize as I was reading and rereading and rereading these papers is it appears that one of these studies is a very poor quality study with a lot of bias built into it, and the results of that study cannot be trusted, and the other study is possibly a fraudulent copy with just numbers changed throughout to make it look different. Which one is the original? It’s anybody’s guess, but the Dönmez et al. paper, the second one that I talked about, was published online in April 2015 and the Ali paper was published in July and August of 2015.

Both papers though were published in what some people refer to as possibly being predatory open-access journals, according to something called the Beall’s List. The original model of how we published research was researchers submitted work to journals and then journals published it behind a paywall. Typically, you would subscribe to receive a journal that was printed and sent to your home or work. As journals started switching to also publishing online, we began to see a new model called the open-access model. In the last 10 years or so, open-access publishing has been applauded as a way to get more research into the hands of the public. However, just like anything, this model can be abused, and it often is.

When I was working at a university as a researcher and professor, I was constantly spammed by phishing schemes of predatory publishing companies that would beg me to publish in their open-access journals. How would you get in these open-access journals? You would simply send them your paper and some money and they would publish you. With the open-access model, there’s what some people call the gold model in which authors pay, i.e., they pay gold for their work to be published, and then the platinum model where authors do not have to pay. However, the gold model is subject to abuse. Jeffrey Beall is a librarian from Colorado in the US who has called attention to predatory open-access publishing. Predatory publishing is a way to exploit researchers and the public by charging publication fees to authors without doing any real peer review to determine whether the articles are legitimate.

Because of predatory publishing, the public can be easily exposed and deceived by fraudulent research. From 2012 to 2017, Jeffrey Beall kept a list online that had conditions for what made a journal predatory, as well as a list of journals that he considered to meet the criteria for being a predator publisher. Interestingly in 2017, after immense pressure from his employer, the University of Colorado Denver, Jeffrey Beall took the list down. The list is now maintained by an anonymous person from a European country. You can find it at beallslist.net, and Beall is spelled B-E-A-L-L. One of the problems with predatory publishing with the open-access model is that researchers and clinicians who work in academia, they’re under a ton of pressure to get publications in order to get promoted and have salary increases.

For example, when I was working on the tenure track, I was required to have anywhere from two to four research-based publications per year with at least one of them being as a first author. If I were to submit to one of these open-access journals that doesn’t really do peer review and basically accepts every paper that’s sent to it, that would get me a publication on my resume or CV. You can see how that could encourage misconduct among researchers, because you can submit fake or fraudulent or counterfeit studies and it looks like you’ve got a publication on your resume. In turn, that hurts the public because now we have junk or counterfeit or fraudulent research out there. Then the companies that engage in predatory publishing, sometimes called deceptive publishing, well, the more articles they accept, the more money they make.

They have almost no incentive to screen for poor quality or fraudulent research. That’s not to say that there aren’t good open-access publication companies. Many of the open-access publication companies are high quality. But it means that researchers and authors have to be very careful about who they submit their research to, and the public has to be very careful about accepting a study’s findings for fact if you’re not familiar with how to interpret research or if you’re not familiar with the journal where it’s being published. There are thousands and thousands of open-access journal companies now, which makes it really hard to know which ones are good and which ones are fraudulent.

The entire field has just exploded in the last five to 10 years. I’ll put some links if you want to learn more about this issue in the show notes. All I know is that I went down a really deep rabbit hole trying to figure out why I was reading these ridiculous numbers in these research studies. We have one more of those four research studies to look at, and thankfully, this one is a little bit better than the last two. This study was published by Dieb et al. in 2019, and it was also carried out in Egypt and registered ahead of time with clinicaltrials.gov, which always a good sign, typically meaning that it’s a legitimate trial because they published ahead of time that they were going to do the study, and then they went and did the study and then published the results.

In this study, they had 200 people who were randomly assigned to either perineal massage and Kegels practice, or Kegels practice alone. Unfortunately, I believe that this study was also at a high risk of bias, although this does seem to be a legitimate study that was actually carried out. It doesn’t seem like the researchers were blinded, which creates some of those same problems then again, where you can manipulate the results if you know who’s in which group, and it doesn’t seem like the randomization was effective. They didn’t really disclose their randomization methods adequately. What I can tell you is that there were some differences between the groups, which often means that they didn’t do a good job of randomly assigning people so that their differences even out at the baseline.

They also had zero people drop out of the study, which is highly unlikely for any study, but especially a study like this where you’re looking at perineal massage and you’re looking at outcomes from a vaginal birth. Overall, I would say the study quality is moderate. They found a 30% episiotomy rate in the perineal massage group and a 39% episiotomy rate in the Kegels only group. There were seven third degree tears and zero fourth degree tears in the perineal massage group, and 15 third degree tears and five fourth degree tears in the Kegels only group. This adds up to a 3.5% severe tear rate in the massage group and an 8.8% severe tear rate in the control group.

They also found lower ratings of pain and less need for pain medication in the massage group. They also found, like the other two questionable studies that I mentioned earlier, that the baby’s Apgar scores tended to be lower on average in the perineal massage group. This does not really make sense to me physiologically because the length of the pushing phase was the same in both groups. Apgar scores can be somewhat subjective and it would make sense that if there was no blinding in this study, and you wanted to see a better result in the massage group that it would be easy for your bias to influence, whether consciously or subconsciously, the scores that were given to the babies, as well as whether or not people would be cut with episiotomies.

Okay. We’ve done a deep dive into four of the studies that were included in the meta-analysis and we’ve determined that one was of good quality, but it took place in a setting very different than where many people give birth today, and three of them were very poor quality, two of them extremely so. What does this mean for people who are looking at what’s the big picture of you? What’s the bottom line? Well, the bottom line is that there is evidence that shows perineal massage during pregnancy may be associated with benefits for first time birthing people. But first of all, these benefits were seen in birth settings with extremely high rates of episiotomy and may not be generalizable to people where giving birth where rates of episiotomies are less than 20%.

Ideally, you want to be giving birth in a place where the episiotomy rates are less than 1%. That’s because, as we discussed in episode 206, avoiding an episiotomy is one of the most important ways to protect your perineum. Whether or not you have an episiotomy has nothing to do with the elasticity of your tissue and everything to do with the habits of your provider and how often they like to cut people with the episiotomies. Also, two of the studies in the meta-analysis seem to be very suspect, and at least one of them is probably fraudulent. This is really frustrating because people are already citing this meta-analysis as a reason why we should teach everyone who’s pregnant to use perineal massage.

I’ve seen influencer OB-GYNs and childbirth educators on Instagram and TikTok talking at length about how the evidence supports perineal massage. But the problem is people aren’t looking in depth at the research and realizing that, A, it’s not generalizable, meaning we can’t use this in different situations, and B, the quality of that research is really poor. To be honest, I don’t know if any of the research evidence from that meta-analysis is applicable to birthing places near where I live in the United States. I also believe that the Labrecque et al. researchers were correct when they said that a potential pathway for better outcomes is through increasing education and motivation to avoid episiotomy and protect the perineum.

The more you’re focused on protecting your perineum and looking for ways to prevent tears and prevent episiotomy, the more likely you are to communicate that to your provider, who ultimately has a lot of power in how they practice during that pushing phase when your baby is coming out. You have a lot of power as well, but providers seem to be the driving force between severe perineal tear rates and episiotomy rates. But what about perineal massage? Well, if you’re pregnant and you want to try perineal massage or use it, it does not seem to be harmful and it could possibly be beneficial. But as long as you’re birthing with an attendant and in a birth setting where episiotomy rates are very low, it’s probably not necessary.

It also doesn’t seem to bring any added benefit to people who’ve given birth vaginally before. However, perineal massage is ingrained in a lot of childbirth education. A lot of childbirth educators and doulas include it in their education and recommend their clients use perineal massage during pregnancy. I personally disagree that it needs to be taught to clients. From my opinion, the research seems to be old and flawed, and in some cases, potentially fraudulent, and there are lots better ways to protect your perineum, and that’s why we focus on those other methods in the Evidence Based Birth® Childbirth Class, and we will be covering them in this series. Before I go, I do want to answer one quick question about the EPI-NO®.

The EPI-NO®, that’s a trademarked name, is a device that’s sold with the purpose of supplementing perineal massage and helping you avoid an episiotomy. That’s why it’s called EPI-NO®. It’s a medical device that has a silicone balloon that, when it’s deflated, is about the size of a tampon. You insert it deflated, then pump it up with a little hand pump, and then there’s instructions on how you contract and relax your pelvic floor while the balloon is inside you. Usually, you’re instructed toe it to find a slight discomfort to the edge of your comfort, and then stay there for about 10 minutes. A lot of people ask me is the EPI-NO® effective? Should we be recommending it?

Well, I feel like it’s interesting when there’s companies selling devices that are meant to tell you that your body and your birth canal are dysfunctional, and you need a device to prepare your bodily tissues and the most sensitive part of your body for the birth of the baby. When I heard about this, eight or 10 years ago, I remember feeling skeptical and maybe some people swear by it, they love it. But when I did a literature review to look at the science for some of our pro members at EBB, I did find a few randomized trials on this topic. So far research has not proven that the EPI-NO® is helpful. At EBB, when we’re teaching childbirth classes, we do not recommend devices for stretching your perineum during pregnancy.

Instead, we encourage people to educate themselves about evidence-based ways to lower your risk of severe tears during labor. Most importantly, if possible, finding a care provider or a birth setting that has a very low rate of severe perineal tears and a very low rate of episiotomy with their clients. We’re going to talk about more later on in this series about a few methods, such as the importance of birthing positions, breathing the baby out, and encouraging a slow delivery of the baby’s head.

Next month, we will move on to talk about perineal massage during labor, and I’m excited to share that research with you because there’s a lot of misinformation about that topic as well. In the month after that, we’re going to move on to looking at water birth birthing positions and some time-tested strategies that have been passed down by midwives for lowering the risk of tears. Thanks, everyone, for listening. If you enjoyed this episode, please consider giving us a review on iTunes or wherever you listen to your podcast. We’ll see you next week. Thanks, everyone. Bye.

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