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Exclusive Q&A with Rebecca Dekker – What Does the Evidence Say about Induction for Going Past your Due Date?

April 15th, 2015 by avatar

What does the evidence say about dueToday on Evidence Based Birth, occasional contributor Rebecca Dekker, Phd, RN, APRN, provides a comprehensive research review –  Induction for Going Past your Due Date: What does the Evidence Say?  I had an opportunity to preview the article and ask Rebecca some questions about her most recent project on due dates. I would like to share our conversation here on Science & Sensibility with all of you. Rebecca’s website has become a very useful tool for both professionals and consumers to read about current best practice.Consumers can gather information on the common issues that they maybe dealing with during their pregnancies. Professionals can find resources and information to share with students and clients.  How do you cover the topic of inductions at term for due date?  After reading today’s S&S post and Rebecca’s research post, do you think you might share additional information or change what you discuss?  Let us know in the comments section.- Sharon Muza, Community Manager, Science & Sensibility.

Note: if the Evidence Based Birth post is not up yet, try again in a bit, it should be momentarily.

Sharon Muza: Why did you decide to tackle the topic of due dates as your next research project and blog post?

Rebecca Dekker: Last year, I polled my audience as to what they would like me to write about next. They overwhelmingly said that they wanted an Evidence Based Birth article about Advanced Maternal Age (AMA), or pregnancy over the age of 35. As I started reviewing the research on AMA, it became abundantly clear to me that I had to first publish an article all about the evidence on due dates. This article on induction for due dates creates a solid foundation on which my readers can learn about induction versus waiting for spontaneous labor in pregnant women who are over the age of 35.

SM: When you started to dig into the research, were there any findings that surprised you, or that you didn’t expect?

RD: There were two topics that I really had to dig into in order to thoroughly understand.

The first is the topic on stillbirth rates. I began to understand that it’s really important to know which mathematical formula researchers used to calculate stillbirth rates by gestational age. It was interesting to read through the old research studies and letters to the editors where researchers argued about which math formulas were best. In the end, I had to draw up diagrams of the different formulas (you can see those diagrams in the article) for the formulas to make sense in my head, and once I did, the issue made perfect sense!

Before 1987 (and even after 1987, in some cases) researchers really DID use the wrong formulas, and it’s kind of funny to think that for so many years, they used the wrong math! In general, I thought the research studies on stillbirth rates by gestational age were really interesting…it raised questions for me that I couldn’t answer, like why are the stillbirth rates so different at different times and in different countries? Also, it was really clear from the research that stillbirth rates are drastically different depending on whether you are looking at samples that include or don’t include babies who are growth-restricted.

The other big breakthrough or “ah ha” moment I had was when I finally realized the true meaning of the Hannah (1992) Post-Term study. There was such a huge paradox in their findings… why did they find that the expectant management group had HIGHER Cesarean rates, when clinicians instinctively know that inductions have higher Cesarean rates compared to spontaneous labor? Since all of the meta-analyses rely heavily on the Hannah study, I knew I needed to figure this problem out.

There are a couple different theories in the literature as to why there were higher C-section rates in the expectant management group in Hannah’s study. One theory is that the induction group had Prostaglandins to ripen the cervix, while the expectant management group did not. However, in a secondary data analysis published by Hannah et al. in 1996, they found that this probably played just a minor role.

Another theory is that as women go further along in their pregnancy, physicians get more nervous about the risk of stillbirth, and so they may be quicker to recommend a Cesarean in a woman who is past 42 or 43 weeks, compared to one who is just at 41 weeks. This theory has been proposed by several different researchers in the literature, and there is probably some merit to it.

But in the end, I found out exactly why the C-section rates are higher in the expectant management group in the Hannah Post Term study (and thus in every meta-analysis that has ever been done on this topic). Don’t you want to know why? I finally found the evidence in Hannah’s 1996 article called “Putting the merits of a policy of induction of labor into perspective.” The data that I was looking for were not in the original Hannah study… they were in this commentary that was published several years later.

dekker headshotThe reason that Cesarean rates were higher in the expectant management group in the Hannah study is because the women who were randomly assigned to wait for spontaneous labor, but actually ended up with inductions, had Cesarean rates that were nearly double of those among women who had spontaneous labor. Some of these inductions were medically indicated, and some of them were requested by the mother. In any case, this explains the paradox. It’s not spontaneous labor that leads to higher Cesarean rates with expectant management… the higher Cesarean rates come from women who wait for spontaneous labor but end up having inductions instead. 

So the good news is that if you choose “expectant management” at 41-42 weeks (which is a term that I really dislike, because it implies that you’re “managing” women, but I digress), your chances of a Cesarean are pretty low if you go into spontaneous labor. But if you end up being one of the women who waits and then later on chooses to have an induction, or ends up with a medically indicated induction, then your chances of a Cesarean are much higher than if you had just had an elective induction at 41 weeks.

SM: What information do you recommend that childbirth educators share to help families make informed decisions about inductions and actions to take as a due date comes and then even goes, and they are still pregnant.

RD: First of all, I think it’s important for all of us to dispel the myth of the 40 week due date. There really is no such thing as a due date. There is a range of time in which most women will go into labor on their own. About half of women will go into labor by 40 weeks and 5 days if you’re a first-time mom (or 40 weeks and 3 days if you’ve given birth before), and the other half will go into labor after that.

The other thing that it is important for childbirth educators to do is to encourage families—early in pregnancy—to talk with their health care provider about when they recommend induction, and why.

There are some health care providers who believe strongly that induction at 39, 40, 41, or 42 weeks reduces the risk of stillbirth and other poor outcomes. There are parents who have the same preference. Then there are other health care providers who believe strongly that induction for going past your due date is a bad thing, and shouldn’t be attempted unless there are clear medical reasons for the induction. And there are parents who will tend to share that same preference. Either way, parents need accurate information about the benefits and risks of waiting versus elective induction at 41-42 weeks—because both are valid options.

But it’s probably best to avoid a mismatch between parents and providers. If parents believes strongly that they want to wait for spontaneous labor, and they understand the risks, but they have a care provider who believes strongly in elective induction at 41 weeks, then they will run into problems when they reach 41 or 42 weeks and their care provider disagrees with their decision.

Clearly, there are benefits to experiencing spontaneous labor and avoiding unnecessary interventions. But at the same time there is a rise in the relative risk of stillbirth starting at about 39 weeks, depending on which study you are looking at. However, the overall risk is still low up until 42 weeks. At 42 weeks, the risk of stillbirth rises to about 1 in 1,000 in babies who are not growth-restricted. The risk may be higher in some women who have additional risk factors for stillbirth. Women who experience post-term pregnancy (past 42 weeks) are more likely to experience infections and Cesareans, and their infants are more likely to experience meconium aspiration syndrome, NICU admissions, and low Apgar scores.

SM: Would you recommend that families have conversations about how their due date is being calculated, at the first prenatal with their health care providers. What should that conversation include?

RD: I would recommend asking these questions:

  • What is the estimated date range that I might expect to give birth—not based on Naegele’s rule, but based on more current research about the average length of a pregnancy?
  • Did you use my Last Menstrual Period or an early ultrasound to determine my baby’s gestational age?
  • Has my due date been changed in my chart at any point in my pregnancy? If so, why?

SM: The concept of being “overdue” if still pregnant at the due date is firmly ingrained in our culture. What do you think needs to happen both socially and practically to change the way we think about the “due date?”

RD: We need to start telling everyone, “There is no such thing as a due date.” To help women deal with the social pressure they may experience at the end of pregnancy, I’ve created several Facebook profile photos that they can use as their Facebook profile when they get close to their traditional “due date.” To download those photos, visit www.evidendebasedbirth.com/duedates

SM: How available and widely used are first trimester ultrasounds? If first trimester ultrasounds were done as the standard of care in all pregnancies, would it result in more accurate due dates and better outcomes? Do you think there should be a shift to that method of EDD estimation?

RD: I think the option of having a first trimester ultrasound definitely needs to be part of the conversation between a woman and her care provider, especially because it has implications for the number of women who will be induced for “post-term.” I could not find any data on the percentage of women who have an ultrasound before 20 weeks, but in my geographic area it seems to be nearly 100%, anecdotally.

If your estimated due date is based on your LMP, you have a 10% chance of reaching the post-term period, but if it’s based on an early ultrasound, you only have a 3% chance of reaching 42 weeks.

One strange thing that I noted is that ACOG still prefers the LMP date over an early ultrasound date. They have specific guidelines in their practice bulletin about when you need to switch from the LMP date to an ultrasound date, but the default date is still the LMP. I found that rather odd, since research is very clear that ultrasound data is more accurate than the LMP, for a host of reasons!

Before I published the due dates article, I reached out to Tara Elrod, a Certified Direct Entry Midwife in Alaska, to get her expert feedback as a home birth midwife. She raised an excellent point:

“It is of significant interest to me as a licensed midwife practicing solely in the Out-of-Hospital setting that ultrasounds done in early pregnancy are more accurate than using LMP. If early ultrasound dating was achieved, it’s thought that this would ultimately equate to less women being induced for post-term pregnancy. This is significant to midwives such as myself due to the scope-of-care regulation of not providing care beyond 42 weeks. While an initial- and perhaps arguably by some ‘elective’ ultrasound-  may not be a popular choice in the midwife clientele population, a thoughtful risk versus benefit consideration should occur, as to assess the circumstance of “risking out” of care for suspected post-dates. [In my licensing state, my scope of care is limited to 37+0 weeks to 42+0 weeks, with the occasional patient reaching 42 weeks and therefore subsequently “risking out,” necessitating a transfer of care.]” ~Tara Elrod, CDM

SM: What do you think the economic cost of inductions for due dates is? The social costs? What benefits might we see if we relied on a better system for determining due dates and when to take action based on being postdates?

RD: There are economic costs to both elective inductions and waiting for labor to start on its own. The Hannah Post-Term trial investigators actually published a paper that looked at the cost effectiveness of their intervention, and they found that induction was cheaper than expectant management. This was primarily because with expectant management, there were extra costs related to fetal monitoring (non stress tests, amniotic fluid measurements, etc.) and the increased number of Cesareans in the expectant management group.

But there are many unanswered questions about the cost-effectiveness of elective induction of labor versus waiting for labor to begin (with fetal monitoring), so I’m afraid I can’t make any definitive statements or projections about the economic and social costs of elective inductions. Here is a study that may be of interest to some with further information on this topic.

I do know that in a healthy, low-risk population, birth centers in the National Birth Center Study II provided excellent care at a very low cost with women who had spontaneous births all the way up to 42 weeks. I would love to see researchers analyze maternal and neonatal outcomes in women stratified by gestational age in the Perinatal Data Registry with the American Association of Birth Centers.

 SM: I very much look forward to all your research posts and appreciate the work  and effort you put into doing them. What is on your radar for your next piece?

RD: The next piece will be Advanced Maternal Age!! After that, I will probably be polling my audience to see what they want, but I’m interested in tackling some topics related to pain control (epidurals and nitrous oxide) or maybe episiotomies.

SM: Is there anything else that you want to share about this post or other topics?

RD: No, I would just like to give a big thank you to everyone who helped in some way or another on this article!! There was a great interdisciplinary team who helped ensure that the due dates article passed scrutiny—we had an obstetrician, family physician, nurse midwife, several PhD-prepared researchers, and a certified direct entry midwife all provide expert review before the article was published. I am so thankful to all of them.

References

Hannah, M. E., C. Huh, et al. (1996). “Postterm pregnancy: putting the merits of a policy of induction of labor into perspective.” Birth 23(1): 13-19.

Hannah, M. E., W. J. Hannah, et al. (1992). “Induction of labor as compared with serial antenatal monitoring in post-term pregnancy. A randomized controlled trial. The Canadian Multicenter Post-term Pregnancy Trial Group.” N Engl J Med 326(24): 1587-1592.

 

 

 

Cesarean Birth, Childbirth Education, Evidence Based Medicine, informed Consent, Maternal Quality Improvement, Maternity Care, New Research, Research , , , , ,

Birth By The Numbers Releases New Video – Myth and Reality Concerning US Cesareans

March 19th, 2015 by avatar

birth by numbers header

I have been a huge fan of Dr. Eugene Declercq and his team over at Birth by the Numbers ever since I watched the original Birth by the Numbers bonus segment that was found on the Orgasmic Birth DVD I purchased back in 2008.  I was on the board of REACHE when we brought Dr. Declercq to Seattle to speak at our regional childbirth conference in 2010 and since then have heard him present at various conferences around the country, including most recently at the 2014 Lamaze International/DONA International Confluence, where Dr. Declercq was a keynote speaker.  I enjoy listening to him just as much now as I did back in 2008.  You  may also be familiar with Dr. Declercq’s work as part of the Listening to Mothers research team that has brought us three very valuable studies.

Birth by the Numbers has grown into a valuable and up to date website for the birth professional and the consumer, filled to the brim with useful information, videos, slide presentations and blog posts.  This past Tuesday, the newest video was released on the website: Birth By The Numbers: Part II – Myth and Reality Concerning US Cesareans and is embedded here for you to watch.  We shared Part I in a blog post last fall.


Also available for public use is a slide presentation located in the the “Teaching Tools” section of the Birth by the Numbers website designed to provide additional information, maps, data and resources for this new Myths and Reality Concerning Cesareans video. Included in this slideshow are notes and updates to help you understand the slides and share with others.  This material is freely given for your use.

© Birth by the Numbers

© Birth by the Numbers

This video explores how cesareans impact maternity care systems in the USA.  After watching the video and reviewing the slides, here are some of my top takeaways.

1.  The common reasons given for the nearly 33% cesarean rate in the USA (bigger babies, older mothers, more mothers with obesity, diabetes and hypertension, more multiples and maternal request) just don’t hold water when examined closer.

2. Many women feel pressure from their healthcare provider to have a cesarean, either prenatally or in labor.

3. The leading indicators for cesareans are labor arrest (34%) and nonreassuring fetal heart tracings (23%).

4. The rise in cesareans is not a result of a different indications.  Dr. Declercq quotes a 20 year old article’s title that could still grace the front pages today. “The Rise in Cesarean Section Rate: the same indications – but a lower threshold.”

5. When examining the distribution of cesarean births by states over time, it is clear that those states with the highest cesarean birth rate decades ago, still remain in those spots today.

6. “We are talking about cultural phenomena when we are talking about cesareans, not just medical phenomena.”

7. First time, low risk mothers who birthed at term and experienced labor had a 5% cesarean rate if they went into spontaneous labor and did not receive an epidural.  If they were induced and received an epidural, the cesarean rate was 31%.

8. The United States has the lowest VBAC rate of any industrialized country in the world.

© Birth by the Numbers

© Birth by the Numbers

While the video is rich (and heavy) in data laden charts and diagrams, the message, though not new, is clear.  The US maternity care system is in crisis.  We have to right the ship, and get back on course for healthier and safer births for pregnant people and babies. Take a look at this new video, and think about what messages you can share with the families you work with and in the classes you teach, to help consumers make informed choices about the care they receive during the childbearing year.

Please watch the video, visit the website to view the slides and let me know here in the comments section what you are going to use from this information to improve birth.

Babies, Cesarean Birth, Childbirth Education, informed Consent, Maternal Obesity, Maternal Quality Improvement, Maternity Care, Medical Interventions, New Research , , , ,

Epidural Analgesia: To Delay or Not to Delay, That Is the Question

October 23rd, 2014 by avatar

By Henci Goer

Unless you have been “off the grid” on a solitary trek, surely you have read and heard the recent flurry of discussion surrounding the just released study making the claim that the timing of when a woman receives an epidural (“early” or “late” in labor) made no difference in the rate of cesarean delivery.  Your students and clients may have been asking questions and wondering if the information is accurate.  Award winning author and occasional Science & Sensibility contributor Henci Goer reviews the 9 studies that made up the Cochrane systematic review: Early versus late initiation of epidural analgesia for labour to determine what they actually said.  Read her review here and share if you agree with all the spin in the media about this new research review. Additionally, head on over to the professional and parent Lamaze International sites to check out the new infographic on epidurals to share with your students and clients.- Sharon Muza, Science & Sensibility Manager. 

Epidural infographic oneArticles have been popping up all over the internet in recent weeks citing a new Cochrane systematic review- Early versus late initiation of epidural analgesia for labour, concluding that epidural analgesia for labor needn’t be delayed because early initiation doesn’t increase the likelihood of cesarean delivery, or, for that matter, instrumental vaginal delivery (Sng 2014). The New York Times ran this piece. Some older studies have found that early initiation appeared to increase likelihood of cesarean (Lieberman 1996; Nageotte 1997; Thorp 1991), which is plausible on theoretical grounds. Labor progress might be more vulnerable to disruption in latent than active phase. Persistent occiput posterior might be more frequent if the woman isn’t moving around, and fetal malposition greatly increases the likelihood of cesarean and instrumental delivery. Which is right? Let’s dig into the review.

The review includes 9 randomized controlled trials of “early” versus “late” initiation of epidural analgesia. Participants in all trials were limited to healthy first-time mothers at term with one head-down baby. Five trials further limited participants to women who began labor spontaneously, three mixed women being induced with women beginning labor spontaneously, and in one, all women were induced. Analgesia protocols varied, but all epidural regimens were of modern, low-dose epidurals. So far, so good.

Examining the individual trials, though, we see a major problem. You would think that the reviewers would have rejected trials that failed to divide participants into distinct groups, one having epidural initiation in early labor and the other in more advanced labor, since the point of the review is to determine whether early or late initiation makes a difference. You would think wrong. Of the nine included trials, six failed to do this.

cc photo bryanrmason http://flickr.com/photos/b-may/397189835

cc photo bryanrmason http://flickr.com/photos/b-may/397189835

The two Chestnut trials (1994a; 1994b) had the same design, differing only in that one was of women who were laboring spontaneously at trial entry and the other included women receiving oxytocin for induction or augmentation. Women were admitted to the trial if they were dilated between 3 and 5 cm. Women in the early group got their epidural immediately while women in the late group could have an epidural only if they were dilated to 5 cm or more. If late-group women were not dilated to 5 cm, they were given systemic opioids and could have a second dose of opioid one hour later. They could have an epidural when they attained 5 cm dilation or regardless of dilation, an hour after the second opioid dose. Let’s see how that worked out.

Among the 149 women in the trial that included women receiving oxytocin (Chestnut 1994b), median dilation in the early group at time of epidural initiation was 3.5 cm, meaning that half the women were dilated more and half less than this amount. The interquartile deviation was 0.5 cm, which means that values were fairly tightly clustered around the median. The authors state, however, that cervical dilation was assessed using 0.5 increments which meant that dilation of 3-4 cm was recorded as 3.5. In other words, women in the early group might have been dilated to as much as 4 cm. The median dilation in the late group was 5.0 cm, again with a 0.5 cm interquartile deviation. Some women in the late group, therefore, were not yet dilated to 5 cm when their epidural began, and, in fact, the authors report that 26 of the 75 women (35%) in the late group were given their epidural after the second dose of opioid but before attaining 5 cm dilation. The small interquartile deviation in the late group tells us that few, if any, women would have been dilated much more than 5 cm. Add in that assessing dilation isn’t exact, so women might have been a bit more or less dilated than they were thought to be, and it becomes clear that the “early” and “late” groups must have overlapped considerably. Furthermore, pretty much all of them were dilated between 3 and 5 cm when they got their epidurals, which means that few of these first-time mothers would have been in active labor, as defined by the new ACOG standards.

Overlap between early and late groups must have been even greater in Chestnut et al.’s (1994a) trial of 334 women laboring spontaneously at trial entry because median dilation in the early group was greater than in the other trial (4 cm, rather than 3.5) while median dilation in the late group was the same (5.0 cm), and interquartile deviation was even tighter in the late group (0.25 cm, rather than 0.5 cm). As before, dilation was measured in 0.5 cm increments, which presumably means that women in the early group dilated to 4-5 cm would have been recorded as “4.5,” thereby qualifying them for the “early” group even though they might have been as much as 5 cm dilated.

Based on my analysis, I would argue that there was no clinically meaningful difference in dilation between early and late groups in either trial.

A second pair of trials, one a mixed trial of spontaneous labor onset and induction and the other all induced, also had the same design in both trials (Wong 2005; Wong 2009). All women were less than 4 cm dilated at first request for pain medication. In the early group, women had an opioid injected intrathecally, i.e. the “spinal” part of a combined spinal-epidural, and an epidural catheter was set. At the second request, an epidural was initiated. In the late group, women were given a systemic opioid. At second request, they were given a second dose of systemic opioid if they hadn’t reached 4 cm dilation and an epidural if they had dilated to 4 cm or more. At third request, they were given an epidural regardless of dilation. Women who had no vaginal exam at second request and were given an epidural were “assumed,” in the authors’ words, to be dilated to at least 4 cm. What were the results?

Wong (2005) included 728 women, some beginning labor spontaneously and some induced. You may already have noticed the flaw in the trials’ design: Wong and colleagues confused the issue by considering intrathecal opioid to be equivalent to epidural anesthetic in the early group, although women didn’t actually receive anesthetic until their second request for pain medication some unknown time later. So far as I know we have no evidence that opiods, spinal or epidural, have any effect on labor progress. As to dilation at the time of epidural initiation, 63% of women in the so-called “early” group were either determined or assumed to be at 4 cm dilation or more while in the late group, some unknown proportion were less than 4 cm dilated either because they got their epidural at third pain medication request regardless of dilation or they were assumed to be at 4 or more cm dilation at second request, but weren’t assessed.

Wong (2009), a study of 806 induced women, was set up the same way but reported data somewhat differently. Early-group women were administered a spinal opioid at a median of 2 cm dilation and an interquartile range of 1.5 to 3 cm, which means that values in the middle 50% of the dataset ranged from 1.5 to 3 cm. We have no information on dilation at the time they received their epidural. The median dilation at which late-group women had their epidural initiated was 4 cm with an interquartile range of 3 to 4 cm, that is, in the middle 50% of the dataset ranged from 3 to 4 cm dilation.

As with the Chestnut trials, dilation at time of epidural initiation in the two Wong trials must have overlapped considerably between groups. And, again, few women in the late epidural group would have been in active labor. The Wong trials, however, muddy the waters even further by considering spinal opioid to be the same thing as epidural anesthetic, and while the authors were careful to use the term “neuraxial analgesia,” the Cochrane reviewers made no such distinction.

This brings us to Parameswara (2012), a trial of 120 women that included both spontaneous onset and induced labors. This trial defined the early group as women less than 2 cm dilated at time of epidural initiation and the late group as women more than 2 cm dilated. That’s all the information they provide on group allocation.

Last of the six, we have Wang (2011), a trial of 60 women in spontaneous labor. All women were given intrathecal anesthetic plus opioid. The early group was started on epidural anesthetic plus opioid 20 minutes later whereas the late group had their epidural initiated when they requested additional pain relief. No information is given on dilation at time of epidural initiation. Not only do we have no idea whether early and late groups differed from one another, women in both groups received neuraxial anesthetic at the same time.

In summary, “garbage in, garbage out.” No conclusions can be drawn about the effect of early versus late epidural administration from these six studies.

The other three studies are a different story. They achieve a reasonable separation between groups. Luxman (1998) studied 60 women with spontaneous labor onset. The early group had a mean, i.e., average, dilation of 2.3 cm with a standard deviation of + or – 0.6 cm while the late group had a mean dilation of 4.5 cm + or – 0.2 cm. Ohel (2006) studied a mixed spontaneous onset and induced group of 449 women. The mean dilation at initiation in the early group was 2.4 cm with a standard deviation of 0.7 cm, and the late group had a mean dilation of 4.6 cm with a standard deviation of 1.1 cm. Wang (2009), the behemoth of the trials, included 12,629 women who began labor spontaneously. The early epidural group had a median dilation of 1.6 cm with an interquartile range of 1.1 to 2.8 and the late group a median of 5.1 cm dilation with an interquartile range of 4.2 to 5.7. Cesarean and instrumental delivery rates were similar between early and late groups in all three trials, so had reviewers included only these three trials, they would still have arrived at the same conclusion: early epidural initiation doesn’t increase likelihood of cesarean and instrumental delivery.

We’re not done, though. Wang (2009) points us to a second, even bigger issue.

The Wang (2009) trial, as did all of the trials, limited participants to healthy first-time mothers with no factors that would predispose them to need a cesarean. The Wang trial further excluded women who didn’t begin labor spontaneously. Nevertheless, the cesarean rate in these ultra-low-risk women was an astonishing 23%. Comparing the trials side-by-side reveals wildly varying cesarean and instrumental vaginal delivery rates in what are essentially homogeneous populations.

© Henci Goer

© Henci Goer

© Henci Goer

© Henci Goer

Comparing the trials uncovers that epidural timing doesn’t matter because any effect will be swamped by the much stronger effect of practice variation.

Analysis of the trials teaches us two lessons: First, systematic reviews can’t always be taken at face value because results depend on the beliefs and biases that the reviewers bring to the table. In this case, they blinded reviewers from seeing that two-thirds of the trials they included weren’t measuring two groups of women, one in early- and one in active-phase labor. Second, practice variation can be an unacknowledged and potent confounding factor for any outcome that depends on care provider judgment.

Conclusion

So what’s our take home? Women need to know that with a judicious care provider who strives for spontaneous vaginal birth whenever possible, early epidural administration won’t increase odds of cesarean or instrumental delivery. With an injudicious one, late initiation won’t decrease them. That being said, there are other reasons to delay an epidural. Maternal fever is associated with epidural duration. Running a fever in a slowly progressing labor could tip the balance toward cesarean delivery as well as have consequences for the baby such as keeping the baby in the nursery for observation, testing for infection, or administering prophylactic IV antibiotics. Then too, a woman just might find she can do very well without one. Epidurals can have adverse effects, some of them serious. Comfort measures, cognitive strategies, and all around good emotionally and physically supportive care don’t. Hospitals, therefore, should make available and encourage use of a wide range of non-pharmacologic alternatives and refrain from routine practices that increase discomfort and hinder women from making use of them. Only then can women truly make a free choice about whether and when to have an epidural.

After reading Henci’s review and the study, what information do you feel is important for women to be aware of regarding epidural use in labor?  What will you say when asked about the study and timing of an epidural?  You may want to reference a previous Science & Sensibility article by Andrea Lythgoe, LCCE, on the use of the peanut ball to promote labor progress when a woman has an epidural. – SM 

References

Caughey, A. B., Cahill, A. G., Guise, J. M., & Rouse, D. J. (2014). Safe prevention of the primary cesarean delivery. American journal of obstetrics and gynecology210(3), 179-193.

Chestnut, D. H., McGrath, J. M., Vincent, R. D., Jr., Penning, D. H., Choi, W. W., Bates, J. N., & McFarlane, C. (1994a). Does early administration of epidural analgesia affect obstetric outcome in nulliparous women who are in spontaneous labor? Anesthesiology, 80(6), 1201-1208. http://www.ncbi.nlm.nih.gov/pubmed/8010466?dopt=Citation

Chestnut, D. H., Vincent, R. D., Jr., McGrath, J. M., Choi, W. W., & Bates, J. N. (1994b). Does early administration of epidural analgesia affect obstetric outcome in nulliparous women who are receiving intravenous oxytocin? Anesthesiology, 80(6), 1193-1200. http://www.ncbi.nlm.nih.gov/pubmed/8010465?dopt=Citation

Lieberman, E., Lang, J. M., Cohen, A., D’Agostino, R., Jr., Datta, S., & Frigoletto, F. D., Jr. (1996). Association of epidural analgesia with cesarean delivery in nulliparas. Obstet Gynecol, 88(6), 993-1000. http://www.ncbi.nlm.nih.gov/pubmed/8942841

Luxman, D., Wolman, I., Groutz, A., Cohen, J. R., Lottan, M., Pauzner, D., & David, M. P. (1998). The effect of early epidural block administration on the progression and outcome of labor. Int J Obstet Anesth, 7(3), 161-164. http://www.ncbi.nlm.nih.gov/pubmed/15321209?dopt=Citation

Nageotte, M. P., Larson, D., Rumney, P. J., Sidhu, M., & Hollenbach, K. (1997). Epidural analgesia compared with combined spinal-epidural analgesia during labor in nulliparous women. N Engl J Med, 337(24), 1715-1719. http://www.ncbi.nlm.nih.gov/pubmed/9392696?dopt=Citation

Ohel, G., Gonen, R., Vaida, S., Barak, S., & Gaitini, L. (2006). Early versus late initiation of epidural analgesia in labor: does it increase the risk of cesarean section? A randomized trial. Am J Obstet Gynecol, 194(3), 600-605. http://www.ncbi.nlm.nih.gov/pubmed/16522386?dopt=Citation

Parameswara, G., Kshama, K., Murthy, H. K., Jalaja, K., Venkat, S. (2012). Early epidural labour analgesia: Does it increase the chances of operative delivery? British Journal of Anaesthesia 108(Suppl 2):ii213–ii214. Note: This is an abstract only so all data from it come from the Cochrane review.

Sng, B. L., Leong, W. L., Zeng, Y., Siddiqui, F. J., Assam, P. N., Lim, Y., . . . Sia, A. T. (2014). Early versus late initiation of epidural analgesia for labour. Cochrane Database Syst Rev, 10, CD007238. doi: 10.1002/14651858.CD007238.pub2 http://www.ncbi.nlm.nih.gov/pubmed/25300169

Thorp, J. A., Eckert, L. O., Ang, M. S., Johnston, D. A., Peaceman, A. M., & Parisi, V. M. (1991). Epidural analgesia and cesarean section for dystocia: risk factors in nulliparas. Am J Perinatol, 8(6), 402-410. http://www.ncbi.nlm.nih.gov/pubmed/1814306?dopt=Citation

Wang, F., Shen, X., Guo, X., Peng, Y., & Gu, X. (2009). Epidural analgesia in the latent phase of labor and the risk of cesarean delivery: a five-year randomized controlled trial. Anesthesiology, 111(4), 871-880. http://www.ncbi.nlm.nih.gov/pubmed/19741492?dopt=Citation

Wang, L. Z., Chang, X. Y., Hu, X. X., Tang, B. L., & Xia, F. (2011). The effect on maternal temperature of delaying initiation of the epidural component of combined spinal-epidural analgesia for labor: a pilot study. Int J Obstet Anesth, 20(4), 312-317. http://www.ncbi.nlm.nih.gov/pubmed/21840705

Wong, C. A., McCarthy, R. J., Sullivan, J. T., Scavone, B. M., Gerber, S. E., & Yaghmour, E. A. (2009). Early compared with late neuraxial analgesia in nulliparous labor induction: a randomized controlled trial. Obstet Gynecol, 113(5), 1066-1074. http://www.ncbi.nlm.nih.gov/pubmed/19384122?dopt=Citation

Wong, C. A., Scavone, B. M., Peaceman, A. M., McCarthy, R. J., Sullivan, J. T., Diaz, N. T., . . . Grouper, S. (2005). The risk of cesarean delivery with neuraxial analgesia given early versus late in labor. N Engl J Med, 352(7), 655-665. http://www.ncbi.nlm.nih.gov/pubmed/15716559?dopt=Citation

About Henci Goer

Henci Goer

Henci Goer

Henci Goer, award-winning medical writer and internationally known speaker, is the author of The Thinking Woman’s Guide to a Better Birth and Optimal Care in Childbirth: The Case for a Physiologic Approach She is the winner of the American College of Nurse-Midwives “Best Book of the Year” award. An independent scholar, she is an acknowledged expert on evidence-based maternity care.  

Cesarean Birth, Childbirth Education, Epidural Analgesia, Guest Posts, informed Consent, Medical Interventions, New Research, Systematic Review , , , , , , ,

Lamaze Releases Useful New Infographic: “No Food, No Drink During Labor? NO WAY!”

July 22nd, 2014 by avatar

piece Lamaze_RestrictedFoodDrinkInfographic_FINALToday, Lamaze International releases their newest infographic “No Food, No Drink During Labor? NO WAY!” This useful infographic is available on both the Lamaze International for Professionals website and the Lamaze Parents website. The most recent Listening to Mothers III survey indicated that 60% of women did not drink and 80% did not eat during labor! (DeClercq, 2013) The common practice of restricting food and drink for laboring women is outdated and not supported by evidence.  Unfortunately, most laboring women still face resistance from health care providers and facilities when they desire to eat or drink during their labor.

Lamaze International is hosting a Twitter Chat today, July 22nd, 2014 at 9 PM EST.  Professionals and parents are invited to participate in this live Twitter discussion moderated by Kathryn Konrad, MS, RNC-OB, LCCE, FACCE (@KkonradLCCE) and Robin Weiss, PhDc, MPH, CPH, CD(DONA), CLC, LCCE, Lamaze International’s President Elect. Tonight’s topic is “Restrictions in Labor” including this infographic on eating and drinking along with last month’s infographic on moving in labor (“We Like To Move It, Move It!”) Follow the hashtag #LamazeChat.  New to participating in a Twitter chat?  Check out this article for information on how to participate and get the most out of your experience.

Lamaze International’s Healthy Birth Practices, first released in 2009, discussed in great length the benefits to moving and changing position in labor in the 2nd Healthy Birth Practice: “Walk, Move Around and Change Positions Throughout Labor” as well as the risks to restricting food and drink in the 4th Healthy Birth Practice: “Avoid Interventions That Are Not Medically Necessary.”

These useful infographics complement the Healthy Birth Practices, are easy to share on social media and can be used in the classroom as a poster to help parents to understand how to have the safest and healthiest birth possible.

Won’t you take a moment to check out this newest infographic and share with the expectant families that you work with!  Consider sharing it on your favorite social media outlet (Facebook, Twitter, Pinterest, Instagram) and making it available in your classrooms!

If you have an interesting way you are using these infographics, or would like to just share your thoughts on the infographic topics, please let us know in the comments section. I would love to hear how you use this info in your practice.

Click here to download the newest infographic “No Food, No Drink During Labor? NO WAY!”

You may access all the infographics available here!

References

Declercq, E. R., Sakala, C., Corry, M. P., Applebaum, S., & Herrlich, A. (2013). Listening to mothers III: Pregnancy and birth. New York, NY: Childbirth Connection.

Childbirth Education, Evidence Based Medicine, Healthy Birth Practices, informed Consent, Lamaze International, Maternity Care, Medical Interventions, Push for Your Baby , , , , ,

Evidence on Water Birth Safety – Exclusive Q&A with Rebecca Dekker on her New Research

July 10th, 2014 by avatar

 

Evidence Based Birth , a popular blog written by occasional Science & Sensibility contributor Rebecca Dekker, PhD, RN, APRN, has just today published a new article, “Evidence on Water Birth Safety” that looks at the current research on the safety of water birth for mothers and newborns.  Rebecca researched and wrote that article in response to the joint Opinion Statement “Immersion in Water During Labor and Delivery” released in March, 2014 by the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics.  I had the opportunity to ask Rebecca some questions about her research into the evidence available on water birth, her thoughts on the Opinion Statement and her conclusions after writing her review. – Sharon Muza, Science & Sensibility Community Manager.

Sharon Muza: First off, is it waterbirth or water birth?

Rebecca Dekker: That’s actually good question! Research experts tend to use the term “waterbirth.” Google prefers “water birth.” So I used both terms in my article to satisfy everyone!

SM: Have you heard or been told of stories of existing water birth programs shutting down or being modified as a result of the recent AAP/ACOG opinion?

RD: Yes, definitely. There was a mother in my state who contacted me this spring because she was 34 weeks pregnant and her hospital decided not to offer waterbirth anymore. She had given birth to her daughter in a waterbirth at the same hospital two years earlier. With her current pregnancy, she had been planning another hospital waterbirth. She had the support of her nurse midwife, the hospital obstetricians, and hospital policy. However, immediately after the release of the ACOG/AAP opinion, the hospital CEO put an immediate stop to waterbirth. This particular mother ended up switching providers at 36 weeks to a home birth midwife. A few weeks ago, she gave birth to her second baby, at home in the water. This mother told me how disheartening it was that an administrator in an office had decided limit her birth options, even though physicians and midwives at the same hospital were supportive of her informed decision to have a waterbirth.

In another hospital in my hometown, they were gearing up to start a waterbirth program this year—it was going to be the first hospital where waterbirth would be available in our city—and it was put on hold because of the ACOG/AAP Opinion.

Then of course, there were a lot of media reports about various hospital systems that suspended their waterbirth programs. One hospital system in particular, in Minnesota, got a lot of media coverage.

SM: Did you attempt to contact ACOG/AAP with questions and if so, did they respond?

RD: Yes. As soon as I realized that the ACOG/AAP Opinion Statement had so many major scientific errors, I contacted ImprovingBirth.org and together we wrote two letters. I wrote a letter regarding the scientific problems with the Opinion Statement, and ImprovingBirth.org wrote a letter asking ACOG/AAP to suspend the statement until further review. The letters were received by the President and President-Elect of ACOG, and they were forwarded to the Practice Committee. We were told that the Practice Committee would review the contents of our letters at their meeting in mid-June, and that was the last update that we have received.

SM: What is the difference between an “Opinion Statement” and other types of policy recommendations or guidelines that these organizations release? Does it carry as much weight as practice bulletins?

RD: That’s an interesting question. At the very top of the Opinion Statement, there are two sentences that read: “This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.” But, as you will see, some hospitals do see this statement as dictating an exclusive course of treatment, and others don’t.

I have heard that “opinions” do not carry as much weight as “practice bulletins,” but it really depends on who the audience is and who is listening. In other words, some hospitals may take the Opinion Statement word-for-word and feel that they must follow it to the letter, and other hospitals may ignore it. A lot of it probably depends on the advice of their risk management lawyers.

For example, a nurse midwife at a hospital in Illinois sent me a letter that their risk-management attorneys had put together to advise them on this issue. (She had the attorney’s permission to share the letter with me). These lawyers basically said that when a committee of two highly-respected organizations says that the practice of waterbirth should be considered an experimental procedure, both health care providers and hospitals are “charged with a duty to heed that statement,” unless they find research evidence that waterbirth has benefits for the mother or fetus, and that the evidence can override the Committee’s conclusions.

On the other hand, another risk management lawyer for a large hospital system told me that of course hospitals are not under any obligation to follow an ACOG/AAP Opinion Statement. It’s simply just that—an opinion.

So as to how much weight the Opinion Statement carries—I guess it is really dependent on who is reading it!

SM: How would you suggest a well-designed research study be conducted to examine the efficacy and safety of waterbirth? Or would you say that satisfactory research already exists.

RD: First of all, I want to say that I’m really looking forward to the publication of the American Association of Birth Centers (AABC) data on nearly 4,000 waterbirths that occurred in birth centers in the U.S., to see what kind of methods they used. From what I hear, they had really fantastic outcomes.

And it’s also really exciting that anyone can join the AABC research registry, whether you practice in a hospital, birth center, or at home. The more people who join the registry, the bigger the data set will be for future research and analysis. Visit the AABC PDR website to find out more.

I think it’s pretty clear that a randomized trial would be difficult to do, because we would need at least 2,000 women in the overall sample in order to tell differences in rare outcomes. So instead we need well-designed observational studies.

My dream study on waterbirth would be this: A large, prospective, multi-center registry that follows women who are interested in waterbirth and compares three groups: 1) women who have a waterbirth, 2) women who want a waterbirth and are eligible for a waterbirth but the tub is not available—so they had a conventional land birth, 3) women who labored in water but got out of the tub for the birth. The researchers would measure an extensive list of both maternal and fetal outcomes.

It would also be interesting to do an additional analysis to compare women from group 2 who had an epidural with women from group 1 who had a waterbirth. To my knowledge, only one study has specifically compared women who had waterbirths with women who had epidurals. Since these are two very different forms of pain relief, it would be nice to have a side-by-side comparison to help inform mothers’ decision making.

SM: What was the most surprising finding to you in researching your article on the evidence on water birth safety?

RD: I guess I was most surprised by how poorly the ACOG/AAP literature review was done in their Opinion Statement. During my initial read of it, I instantly recognized multiple scientific problems.

A glance at the references they cited was so surprising to me—when discussing the fetal risks of waterbirth, they referenced a laboratory study of pregnant rats that were randomized to exercise swimming in cold or warm water! There weren’t even any rat waterbirths! It was both hilarious and sad, at the same time! And it’s not like you have to read the entire rat article to figure out that they were talking about pregnant rats—it was right there in their list of references, in the title of the article, “Effect of water temperature on exercise-induced maternal hyperthermia on fetal development in rats.”

These kind of mistakes were very surprising, and incredibly disappointing. I expect a lot higher standards from such important professional organizations. These organizations have a huge influence on the care of women in the U.S., and even around the world, as other countries look to their recommendations for guidance. The fact that they were making a sweeping statement about the availability of a pain relief option during labor, based on an ill-researched and substandard literature review—was very surprising indeed.

SM: What was the most interesting fact you discovered during your research?

RD: With all this talk from ACOG and the AAP about how there are “no maternal benefits,” I was fascinated as I dug into the research to almost immediately find that waterbirth has a strong negative effect on the use of episiotomy during childbirth.

Every single study on this topic has shown that waterbirth drastically reduces and in some cases completely eliminates the use of episiotomy. Many women are eager to avoid episiotomies, and to have intact perineums, and waterbirth is associated with both lower episiotomy rates and higher intact perineum rates. That is a substantial maternal benefit. It’s kind of sad to see leading professional organizations not even give the slightest nod to waterbirth’s ability to keep women’s perineums intact.

In fact, I’m puzzled as to why keeping women’s perineums intact and uncut is not perceived as a benefit by anyone other than the women themselves. And here is the heart of declaring waterbirth as “not having enough benefits” to justify its use: Who decides the benefits? Who decides what a benefit is, if not the person benefitting? Who should be weighing the potential harms and the potential benefits of waterbirth, and making an informed decision about their options? Should it be the mother? Or should it be the obstetrician?

SM: What can families do if they want waterbirth to be an option in their local hospital or birth center and it has been taken away or not even ever been offered before?

RD: That’s a hard question. It’s a big problem.

Basically what it boils down to is this—there are a lot of restraining forces that keep waterbirth from being a pain relief option for many women. But there are also some positive driving forces. According to change theory, if you want to see a behavior change at the healthcare organization level, it is a matter of decreasing the restraining forces, while increasing the driving forces. Debunking the ACOG/AAP Opinion Statement is an important piece of decreasing restraining forces. On the other side, increasing consumer pressure can help drive positive change.

SM: Do you think that consumers will be responding with their health dollars in changing providers and facilities in order to have a waterbirth?

RD: I think that if a hospital offered waterbirth as an option to low-risk women, that this could be a huge marketing tool and would put that hospital at an advantage in their community, especially if the other hospitals did not offer waterbirth.

SM: The ACOG/AAP opinion sounded very reactionary, but to what I am not sure. What do you think are the biggest concerns these organizations have and why was this topic even addressed? Weren’t things sailing along smoothly in the many facilities already offering a water birth option?

RD: I don’t know if you saw the interview with Medscape, but one of the authors of the Opinion Statement suggested that they were partially motivated to come out with this statement because of the increase in home birth, and they perceive that women are having a lot of waterbirths at home.

I also wonder if they are hoping to leverage their influence as the FDA considers regulation of birthing pools. You may remember that in 2012, the FDA temporarily prohibited birthing pools from coming into the U.S. Then the FDA held a big meeting with the different midwifery and physician organizations. At that meeting, AAP and ACOG had a united front against waterbirth. So I guess it’s no surprise for them to come out with a joint opinion statement shortly afterwards.

My sincere hope is that the FDA is able to recognize the seriously flawed methods of the literature review in this Opinion Statement, before they come out with any new regulations.

SM: How should childbirth educators be addressing the topic of waterbirth and waterbirth options in our classes in light of the recent ACOG/AAP Opinion Statement and what you have written about in your research review on the Evidence on Water Birth Safety?

RD: It’s not an easy subject. There are both pros and cons to waterbirth, and it’s important for women to discuss waterbirth with their providers so that they can make an informed decision. At the same time, there are a lot of obstetricians who cannot or will not support waterbirth because of ACOG’s position. So if a woman is really interested in waterbirth, she will need to a) find a supportive care provider, b) find a birth setting that encourages and supports waterbirth.

You can’t really have a waterbirth with an unwilling provider or unwilling facility. Well, let me take that back… you can have an “accidental” waterbirth… but unplanned waterbirths have not been included in the research studies on waterbirth, so the evidence on the safety of waterbirth does not generalize to unplanned waterbirths. Also, you have to ask yourself, is your care provider knowledgeable and capable of facilitating a waterbirth? It might not be safe to try to have an “accidental” waterbirth if your care provider and setting have no idea how to handle one. Do they follow infection control policies? Do they know how to handle a shoulder dystocia in the water?

SM: What kind of response do you think there will be from medical organizations and facilities as well as consumers about your research findings?

RD: I hope that it is positive! I would love to see some media coverage of this issue. I hope that the Evidence Based Birth® article inspires discussion among care providers and women, and among colleagues at medical organizations, about the quality of evidence in guidelines, and their role in providing quality information to help guide informed decision-making.

SM: Based on your research, you conclude that the evidence does not support universal bans on waterbirth. Is there anything you would suggest be done or changed to improve waterbirth outcomes for mothers or babies?

RD: The conclusion that I came to in my article—that waterbirth should not be “banned,” is basically what several other respected organization have already said. The American College of Nurse Midwives, the American Association of Birth Centers, the Royal College of Obstetricians and Gynaecologists, and the Royal College of Midwives have all said basically the same thing.

How can we improve waterbirth outcomes? I think continuing to be involved in clinical research studies (such as the AABC registry) is an important way to advance the science and provide evidence on which we can base practice and make more informed decisions with. Also, conducting clinical audits (tracking outcomes) in facilities that provide waterbirth would be important for quality control.

SM: Let’s look into the future. What is next on your plate to write about?

RD: I recently had a writing retreat with several amazing clinicians and researchers who flew from across the country to conduct literature reviews with me. We made an awesome team!! The topics that we have started looking at are: induction for post-dates, induction for ruptured membranes, and evidence-based care for women of advanced maternal age. I can’t decide which one we will publish first! The Evidence Based Birth readers have requested AMA next, but the induction for ruptured membranes article is probably further along than that one. We shall see!!

SM: Is there anything else you would like to share with Science & Sensibility readers on this topic?

RD: Thanks for being so patient with me! I know a lot of people were eagerly awaiting this article, and I wish it could have come out sooner, but these kinds of reviews take a lot of time. Time is my most precious commodity right now!

Has the recent Opinion Statement released by ACOG/AAP impacted birth options in your communities?  Do you discuss this with your clients, students and patients?  What has been the reaction of the families you work with? Let us know below in the comments section! – SM.

ACOG, American Academy of Pediatrics, Babies, Childbirth Education, Evidence Based Medicine, Home Birth, informed Consent, Maternity Care, New Research, Newborns, Research , , , , , , , ,

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