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The PregSense Monitor: A useful new tool or fear-based marketing

August 18th, 2015 by avatar

By Deena Blumenfeld, ERYT, RPYT, LCCE 

pregsensePart of a parent’s job description is to worry about their children. In doing so, parents can help the child maintain their physical health and their emotional wellbeing. However, when the line is crossed into fear based parenting; they may become overprotective to the point of stifling a child’s natural curiosity and the need to learn by making mistakes. They are then at risk of becoming “helicopter parents”.

This is an issue of control. When parents take full control, of their child’s overall well being, they feel that they are protecting them from all the negative aspects of the world. This is a fallacy.

Advertisers and marketers play into this fear and the need for control, that feeds into the parents’ feelings of limited or lack of control. Companies create and market products that provide the impression of safety and security. These products provide a false sense of control for parents, which furthers the illusion that they are doing something “good” or “right” as they “protect” their baby.

Making the rounds of Facebook, and other social media feeds, was this nifty little video about an at-home, wearable baby monitor. It’s called the PregSense Monitor by Nuvo Group. The general consensus from the online community, both mothers and professionals alike, was “Wow! This is amazing! We’ll save so many babies this way!”

My own reaction was a bit different. I’m a skeptic at heart and like all Lamaze educators; I’m a big fan of evidence based products, treatments, procedures and medications. So, I knew I needed to learn more about the PregSense monitor. What’s the evidence behind it? Would it really meet expectations, and save babies and reduce moms’ anxiety?

I attempted to contact Nuvo Group for an interview, but I have not received a response from them at the time of this writing.

Nuvo Group claims

The Israeli tech firm hopes the device will reassure anxious mothers like Michal, in week 32 of her pregnancy, who require monitoring without having to see her doctor.

Claim:  “(The monitor will) allay mothers’ fears by transmitting data about the health of the mother and fetus.”

  • It appears to monitor all of the mother’s vital signs, not unlike a Fitbit or other activity tracker. But how does having the knowledge about your own vital signs and getting additional information about baby’s activities reduce fear?
  • What if the monitor malfunctions? What does that do to a mother’s level of fear?
    • Can one make the assumption that if the monitor isn’t picking up the baby, the mother will become more worried, rather than less. This might lead to increased health care provider visits and further unnecessary medical testing.
  • Could wearing this monitor increase anxiety and potentially cause mothers to be so focused on the monitor it becomes a bit of an obsession?
    • Mothers may become hypervigilant and reliant on the constant stream of “data” available to be reviewed.
  • How would a mother feel if she was unable to wear the monitor one day? Would that increase her fears, even if those fears were unfounded?
    • Removing access, even for a short time could increase worry and interefere with a mother’s ability to continue her daily activities.
  • When there is a constant stream of data it becomes easy to tune out the information. Wouldn’t that defeat the purpose of this device?
    • The information may become white noise and fade into the background, because it’s a nonstop stream.

Claim: Mothers can connect, see and hear the fetus whenever they want, without needing to consult a doctor.

  • Do mothers need a device to help them connect with their babies?
    • This product is trying to create a consumer need that does not exist.
    • Mothers connect with their babies all the time by feeling their movements; talking to them; touching their growing bellies, etc. Would the device reduce this natural mother/fetus interaction? Would a mother be more likely to turn to her smartphone for results from the monitor instead of paying attention to what her baby is actually doing throughout the rhythm of the day.?
  • Using this device would require a health care provider to be monitoring all of these women, all the time. This doesn’t take into account staffing levels or time to complete the task. 24/7 monitoring would be a massive time commitment and responsibility.
  • What about additional liability for the health care provider for not monitoring a woman properly or correctly identifying a problem?
    • We live in a very litigious society. A care provider might be facing a lawsuit if the data from the monitor is not evaluated regularly and an anomaly was missed.
  • Since there are two monitor types – the clinical monitor and the consumer monitor, this raises additional questions. What if the mother is low-risk and healthy, but chooses to wear the consumer model, without a prescription to “reassure” herself that all is well?
    • Would the physician then be required to monitor this mother, if there is no medical need and was not advised by the physician?
    • What is the physician’s liability in this case?

Claim: “We will be able to analyze this data to predict about events of pregnancy, like preterm labor, like preeclampsia and more and we will be able to intervene in the right time…”

  • Preterm labor may be able to be detected with continuous monitoring. However, the monitor is only identifying contractions. It’s not looking at vaginal discharge, cervical change, flu-like symptoms or downward pressure from the baby.
  • Would the monitor be able to tell the difference between Braxton-Hicks contractions and early labor?
    • The limited information on Nuvo Group’s website and in their press release does not provide enough information to say for sure.
  • What about those women who experience Braxton-Hicks regularly throughout pregnancy but are not in labor? Would the monitor be helpful or harmful for them in identifying mothers in preterm labor? Would they be in and out of their care provider’s offices more frequently, causing disruption to their daily lives?
  • Preeclampsia cannot be prevented at this time. So, at best, the monitor would let the mother and her care provider know that her blood pressure is high. It would not test for protein in her urine, swelling in her face, headaches, vision changes or any of the other symptoms of preeclampsia, so it’s an incomplete test. Would preeclampsia be missed because mother’s blood pressure is borderline and no other tests were administered.

Claim: Regarding monitoring high risk mothers with continuous monitoring in hospital; the monitor will benefit the health care provider by replacing a bulky machine with one that is lightweight and not connected to the wall.

  • We already have telemetry units for Electronic Fetal Monitoring (EFM), in many hospitals. This device is now redundant and may not integrate with the current software used to monitor the EFM units.
  • How much will this cost a hospital to replace all of their current EFM units by purchasing these PregSense clinical monitors? Is the financial outlay for a new convenience worth the expense?
  • Does the new monitor increase safety for mother and baby in comparison to traditional EFM. Is this alternative truly better for mothers and for doctors in an in-patient setting? Where are the studies that compare the two options? Is the data we get any better? Or are we still subject to human interpretation of the data in identifying the appropriate course of action?

Claim: The PregSense monitor is safer than ultrasounds that can cause tissue damage

nuvo-ritmo-beats-pregsenseAt this point in time there is no evidence and no research, to support monitoring mothers at home during pregnancy. All of the literature refers to full time electronic fetal monitoring (EFM) during labor. Therefore my assumptions are based off of that literature.

Consensus among professional and governmental groups is that, based on the evidence, intermittent auscultation is safer to use in healthy women with uncomplicated pregnancies than electronic fetal monitoring (EFM).  (Heelan 2013) These professional groups include ACOG and AWHONN.

The issue with the beneficial claims made by Nuvo Group is they are in opposition to what the research finds for routine continuous EFM. Continuous EFM in low risk mothers provides no benefit for babies and increases the risk of cesarean for mothers. Therefore the whole concept of the PregSense Monitor is based on an erroneous assumption. It is not possible to prevent a problem by monitoring the baby. A problem can only be detected as it is occurring. So, even if a problem is observed while doing at home monitoring, by the time the mother makes it to the hospital it is may be too late to intervene effectively.

There is also the risk of false positive results. The monitor may detect an anomaly that then increases the mother’s fear about her baby’s well being only to be examined to find out that her baby is doing just fine, causing undue stress and panic.

The claims of the manufacturer of this product don’t hold up under current EFM guidelines and are not FDA approved.

Simplifying fetal monitoring for the care provider may not actually be the case when we look at 24/7 monitoring which still needs to be interpreted by a human being and a potentially large financial investment for a hospital that already has an EFM system that is adequate.

The claim that this product is safer than what currently exists with today’s EFM technology and ultrasonography is unsubstantiated. Without proper research, we do not know if it is safer, more harmful or neutral in relation to EFM and ultrasound as they are done today.

Resolving mother’s fears and helping her connect with the baby are at best an assumption regarding the “softer side” of the product’s results. It may be that some women do have greater piece of mind and feel a greater connection with their baby when using the device. Selling a feeling does not provide medical benefit to mother or baby. It is, however, good marketing.

The takeaway for your students is to have them look at all products with a discerning eye. Fear based marketing is insidious and plays to their emotions. They need to be making informed decisions based on accurate and evidence based information, rather than an emotional response to something that hits them in the heart.

References:

 Nuvo Group’s website

Reuters, “Wearable device provides continuous fetal monitoring”

Dekker, Rebecca, Evidence Based Fetal Monitoring, 2012

Dekker, Rebecca, What is the Evidence for Fetal Monitoring on Admission, 2012

FDA, Avoid Fetal “Keepsake” Images, Heartbeat Monitors, 2014

FDA, Ultrasound Imaging

ACOG Practice Bulletin #106, “Intrapartum Fetal Heart Rate Monitoring: Nomenclature, Interpretation, and General Management Principles,”, July 2009

ACOG press release, ACOG Refines Fetal Heart Rate Monitoring Guidelines, 2009

Lisa Heelan, MSN, FNP-BC, Fetal Monitoring: Creating a Culture of Safety With Informed Choice, J Perinat Educ. 2013 Summer; 22(3): 156–165.

 

 

 

ACOG, Babies, Fetal Monitoring, Guest Posts, Medical Interventions, News about Pregnancy , , , ,

Elective Induction at 40 Weeks? “Decision-Based Evidence Making” Strikes Again

July 14th, 2015 by avatar

Today on Science & Sensibility, contributor Henci Goer takes a look at a systematic review released in spring that examined the impact of elective inductions on the cesarean rate.  Sound analysis or a house of cards?  Looking closer at the studies reviewed provides insight into how the conclusions reached by the investigators might need to be examined more closely.  Henci does that in this review.  Have you read this new systematic review?  Did you come to the same conclusions?  I invite you to share your thoughts in our comments section below. – Sharon Muza, Community Manager, Science & Sensibility.

flickr photo by catharticflux http://flickr.com/photos/catharticflux/2710057340  CC licensed.

flickr photo by catharticflux http://flickr.com/photos/catharticflux/2710057340 CC licensed.

Yet another systematic review has surfaced “Induction of labor at full term in uncomplicated singleton gestations: a systematic review and metaanalysis of randomized controlled trials”  in which reviewers claim that electively inducing healthy women, this time at 40, not 41 weeks, offers benefits and doesn’t increase the cesarean surgery rate (Saccone 2015).

Let’s take a closer look.

Reviewers included five trials: three of them conducted in the 1970s (Cole 1975; Martin 1978; Tylleskar 1979), the fourth published in 2005 (Nielsen 2005), and the fifth in 2014 (Miller 2014). Already we have a problem. Induction management in the 1970s is sufficiently different from management today that results are unlikely to apply to contemporary care, but let’s get down to specifics. Two of the 1970s trials were deemed inadequate for inclusion in the Cochrane review of elective induction (Gulmezoglu 2012), and Miller 2014 is published only as an abstract. Quality systematic reviews exclude abstracts because they don’t provide enough information to evaluate the study. For these reasons, these three trials should be taken off the table..

That leaves us with the other two. Nielsen 2005 states in the title “Comparison of elective induction of labor with favorable Bishop scores versus expectant management: a randomized clinical trial” that it is confined to women with favorable Bishop scores. Anyone familiar with elective induction research should know that inducing when the cervix is ready to go won’t increase the cesarean rate compared with spontaneous onset, but inducing with an unripe cervix is a different story even when using cervical ripening agents (Dunne 2009; Jonsson 2013; Le Ray 2007; Macer 1992; Prysak 1998; Thorsell 2011; Vahratian 2005). As you move the induction date earlier and earlier, more and more women will have an unfavorable cervix, so including a trial limited to women with a ripe one will tilt the playing field in favor of induction. Furthermore, half the participants were multiparous women (113/226). Women with prior vaginal births will go on having vaginal births pretty much no matter what you do to them, which raises another point: inducing earlier means a higher percentage of the inductees will be first-time mothers because first time mothers tend to run longer pregnancies (Mittendorf 1990). Nulliparous women are much more vulnerable to anything that pushes them in the direction of a cesarean. That’s not all: The authors tell us that their hospital has a 7% cesarean rate for dystocia in women at term. If a hospital has a cesarean rate much higher than that—and many do—then results can’t be generalized to it, although, frankly, if the doctors are performing cesareans left and right, induction or spontaneous onset may not make much difference. In short, Nielsen (2005) doesn’t make a compelling argument for 40-week elective induction.

flickr photo by Selbe <3 http://flickr.com/photos/stacylynn/11944718954 shared under a Creative Commons (BY-NC-ND) license

flickr photo by Selbe < http://flickr.com/photos/stacylynn/11944718954 shared under a Creative Commons (BY-NC-ND) license

This brings us to the last trial, Cole (1975). Investigators allocated healthy women either to induction at 40 weeks (111 women) or 41 weeks (117 women). As with Nielsen, half the women had prior vaginal births. Despite being healthy, 22 women were induced for “obstetric complications” (undefined) in the 41-week induction group before reaching 41 weeks. If their doctors induced labor because they had concerns, then this would likely put the women at heightened risk for cesarean. Another 32 women were induced for exceeding 41 weeks. This means that overall, nearly half (46%) of the comparison group didn’t begin labor spontaneously, which would mask any association between induction and cesarean. Leaving the induction vs. spontaneous onset issue aside, the U.S. cesarean rate in the early 1970s was around 5%, which means it was a rare woman who would have one regardless of circumstances. Again, not exactly a strong case for inducing at 40 weeks.

What about the benefits? The best reviewers can come up with are a clinically meaningless reduction in mean blood loss (-58 ml); a lower rate of meconium-stained amniotic fluid (4% vs. 14%), not, mind you, a reduction in meconium aspiration, and therefore clinically meaningless as well; and an equally meaningless reduction in mean birth weight of -136 g (5 oz). If they had found something more impressive, surely they would have reported it.

Really? This merited a pre-publication media blast? Because it amounts to a textbook example of “garbage in, garbage out.” I can see only three possibilities to explain it: either 1) the authors and peer reviewers at the American Journal of Obstetrics and Gynecology (AJOG) don’t know as much as they should about what constitutes a quality systematic review, 2) they are so steeped in medical model thinking—“How early can we get the baby out of that treacherous maternal environment?”—that their judgment is compromised, or 3) we have a “pay no attention to what’s behind the curtain” effort to promote elective induction. I don’t know which is the more troubling, but if it’s the last one, the sad thing is that because it’s got the magic words “systematic review,” “meta-analysis,” and “randomized controlled trials” in the title, it’s likely to succeed.

References

Cole, R. A., Howie, P. W., & Macnaughton, M. C. (1975). Elective induction of labour. A randomised prospective trial. Lancet, 1(7910), 767-770.

Dunne, C., Da Silva, O., Schmidt, G., & Natale, R. (2009). Outcomes of elective labour induction and elective caesarean section in low-risk pregnancies between 37 and 41 weeks’ gestation. J Obstet Gynaecol Can, 31(12), 1124-1130.

Gulmezoglu, A. M., Crowther, C. A., Middleton, P., & Heatley, E. (2012). Induction of labour for improving birth outcomes for women at or beyond term. Cochrane Database Syst Rev, 6, CD004945.

Jonsson, M., Cnattingius, S., & Wikstrom, A. K. (2013). Elective induction of labor and the risk of cesarean section in low-risk parous women: a cohort study. Acta Obstet Gynecol Scand, 92(2), 198-203. doi: 10.1111/aogs.12043

Le Ray, C., Carayol, M., Breart, G., & Goffinet, F. (2007). Elective induction of labor: failure to follow guidelines and risk of cesarean delivery. Acta Obstet Gynecol Scand, 86(6), 657-665.

Macer, J. A., Macer, C. L., & Chan, L. S. (1992). Elective induction versus spontaneous labor: a retrospective study of complications and outcome. Am J Obstet Gynecol, 166(6 Pt 1), 1690-1696; discussion 1696-1697.

Martin, D. H., Thompson, W., Pinkerton, J. H., & Watson, J. D. (1978). A randomized controlled trial of selective planned delivery. Br J Obstet Gynaecol, 85(2), 109-113.

Miller, N., Cypher, R., Pates, J., & Nielsen, P. E. (2014). Elective induction of nulliparous labor at 39 weeks of gestation: a randomized clinical trial. Obstet Gynecol,132(Suppl 1):72S.

Mittendorf, R., Williams, M. A., Berkey, C. S., & Cotter, P. F. (1990). The length of uncomplicated human gestation. Obstet Gynecol, 75(6), 929-932.

Nielsen, P. E., Howard, B. C., Hill, C. C., Larson, P. L., Holland, R. H., & Smith, P. N. (2005). Comparison of elective induction of labor with favorable Bishop scores versus expectant management: a randomized clinical trial. J Matern Fetal Neontal Med, 18:59-64.

Prysak, M., & Castronova, F. C. (1998). Elective induction versus spontaneous labor: a case-control analysis of safety and efficacy. Obstet Gynecol, 92(1), 47-52.

Saccone, G., & Berghella, V. (2015). Induction of labor at full term in uncomplicated singleton gestations: a systematic review and metaanalysis of randomized controlled trials. American journal of obstetrics and gynecology.

Thorsell, M., Lyrenas, S., Andolf, E., & Kaijser, M. (2011). Induction of labor and the risk for emergency cesarean section in nulliparous and multiparous women. Acta Obstet Gynecol Scand, 90(10), 1094-1099. doi: 10.1111/j.1600-0412.2011.01213.x

Tylleskar, J., Finnstrom, O., Leijon, I, et al. (1979). Spontaneous labor and elective induction – a prospective randomized study. Effects on mother and fetus. Acta Obstet Gynaecol Scand, 58:513-518.

Vahratian, A., Zhang, J., Troendle, J. F., Sciscione, A. C., & Hoffman, M. K. (2005). Labor progression and risk of cesarean delivery in electively induced nulliparas. Obstet Gynecol, 105(4), 698-704.out

About 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.

 

ACOG, Cesarean Birth, Childbirth Education, Do No Harm, Evidence Based Medicine, Guest Posts, Medical Interventions, New Research, Research , , , , , ,

Great Line-up of Plenary Conference Speakers and President’s Desk Updates

May 14th, 2015 by avatar

lamaze icea conf 2015Today on Science & Sensibility – news you can use!  Plenary speakers have been announced for the upcoming conference and Robin Elise Weiss, Lamaze International’s Board President has a new series of informative videos called “From the President’s Desk” that you will want to check out.  Read on for information on both of these topics.

Lamaze/ICEA Joint Conference News

Lamaze International and the International Childbirth Education Association (ICEA) just announced their plenary (general session) speaker line up for the joint Lamaze/ICEA 2015 conference at Planet Hollywood, Las Vegas on September 17-20.  Four speakers will address the entire conference in general sessions and I am very much looking forward to listening to their presentations along with the many concurrent sessions that will be offered over the four days of the conference.

ICEA and Lamaze celebrated their 50th anniversaries together in 2010 in Milwaukee, WI with a well attended “mega-conference” that had great energy and educational offerings and I expect that this conference will be just as big and wonderful.  Bringing together two leaders in childbirth education to hold a joint conference means that all attendees will benefit in numerous ways.

The theme of the Las Vegas conference is “Raising the Stakes for Evidence Based Practices & Education in Childbirth” and I know that educators, doctors, midwives, doulas, L&D nurses, IBCLCs and others will come together and take advantage of this joint conference to network, learn, receive contact hours, and socialize with other professionals.  Maybe, even win a little at the blackjack tables or take in a great show.  Las Vegas is a great venue for this conference, offering a wide variety of locales, activities and nightlife to enjoy outside of conference  hours.

This year’s plenary speakers

camman head shot 2015William Camann, MD
Director of Obstetric Anesthesia, Brigham and Women’s Hospital,  Associate Professor of Anesthesia, Harvard Medical School

Presentation: What does the informed childbirth educator need to know about labor pain relief in 2015?

 

 

combellick head shot 2015Joan Combellick, MSN, MPH,CM
PhD Student, NYU College of Nursing
Midwife, Hudson River Healthcare

Presentation: Watchful Waiting Revisited: Birth Experience and the Neonatal Microbiome

 

 

Joseph head shot 2015Jennie Joseph, LM, CPM
Co-Founder and Executive Director
Commonsense Childbirth School of Midwifery

Presentation:The Perinatal Revolution: Reducing Disparities and Saving Lives through Perinatal Education and Support

 

 

mcallister head shot 2015Elan McAllister
Founder, Choices in Childbirth

Presentation: No Day But Today

 

 

 

 

Concurrent sessions

Watch the website for soon to be released information on concurrent speakers and their topics.  Concurrent sessions will fall into one of four categories:

  • Evidence-Based Teaching and Practice
  • Using Technology and Innovation to Reach Childbearing and Breastfeeding Women
  • New and Emerging Research in the Field of Childbearing and Breastfeeding
  • Challenges of the Maternal Child Professional

Preconference workshops

Additionally, there will be two preconference workshops available for a small additional fee.  These 4 hour workshops allow you to really immerse yourself in the topic and leave with concrete skills applicable to your work with childbearing families.

  • Movement in Birth (AM)
  • Social Media Smarts: Strategic Online Marketing for the Busy Childbirth Professional (PM)

Early bird registration is open until August 1, 2015, so registering now allows you to save money on the conference fees and make your travel and hotel plans now.  Look for interviews with the plenary speakers over the next few months on Science & Sensibility.

 From the President’s Desk

Board President Robin Elise Weiss, Ph.D, has recently made a series of short and useful videos for Lamaze International on several topics.  The video series is called “From the President’s Desk”. Released to date are several on cesareans;

Robin’s newest video discusses the recently released ACOG committee opinion “Clinical Guidelines and Standardization of Practice to Improve Outcomes“. This video helps both birth professionals and consumers to understand how pushing for the best evidence based care can result in both pregnant people and their babies having improved outcomes.  ACOG wants to be able to offer best practice to those receiving care from its members, and consumers can help by sharing their desire to receive care in line with recommended guidelines.

Head over to Lamaze International’s YouTube Channel to see all the offerings, share the relevant videos with your students and clients and subscribe to the channel so that you don’t miss any of the releases.

2015 Lamaze & ICEA Joint Conference, ACOG, Cesarean Birth, Childbirth Education, Conference Calendar, Conference Schedule, Continuing Education, Lamaze International, Lamaze News , , , , , , , , , , , ,

Best in Birth for 2014

December 30th, 2014 by avatar

By Cara Terreri, LCCE

Best of  BirthAs the year winds down this week, many will take stock of the best and worst of happenings throughout the year. In the world of maternity care, there are several notable and promising advances, discoveries, and recommendations in care practices. ICYMI (in case you missed it), we’d like to share the best in birth for 2014.

The Journal of Midwifery and Women’s Health released important new U.S. research on the outcomes of home birth entitled Outcomes of Care for 16,924 Planned Home Births in the United States: The Midwives Alliance of North America Statistics Project, 2004 to 2009.” This was the first study on outcomes of home births since 2005. For a in-depth review of the study, check out this and this.

In February, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine issued a joint Obstetric Care Consensus Statement: Safe Prevention of the Primary Cesarean Delivery. The statement aims to change the way practitioners manage labor in an effort to reduce the cesarean rate, and was considered by many a major game changer in how women are cared for in labor. The ACOG press release is here, which provides more detail of the study. Science & Sensibility covered it here.

Evidence Based Birth a well-respected resource site for birth practices, published the article, “Evidence for the Vitamin K Shot in Newborns,” which examines Vitamin K deficiency bleeding (VKDB), a rare but serious consequence of insufficient Vitamin K in a newborn or infant that can be prevented by administering an injection of Vitamin K at birth. The article helps to clear up many misconceptions and questions surrounding the Vitamin K shot.  Sharon Muza interviews Rebecca on this topic here.

Lamaze International launched a series of online parent classes that cover a variety of topics on pregnancy, birth, and breastfeeding. The online classes are presented in an interactive, engaging format with unlimited access so you can complete the class at your own pace. They provide vital information, and are recommended to be followed up with a traditional, in-depth childbirth class. Topics covered include, VBAC, Six Healthy Birth Practices, and Breastfeeding Basics.  A Pain Management and Coping Skills class will be released shortly in the new year.

The journal Birth published a study that compared the difference between nonpharmacologic (aka: non-drug) pain management during labor with more typical pain relief techniques. Results showed that nonpharmacologic pain relief techniques can reduce the need for medical interventions. Read an in-depth review here.

The “family-centered cesarean” birth continued to emerge as an option for more families as new providers and hospitals adopted practices to facilitate the approach. For more information, check out the Family Centered Cesarean Project and this article.

Out-of-hospital (OOH) births rates continued to increase, according to a report from the National Center for Health Statistics released this year. The report also showed that OOH births generally had lower risk than hospital births, with lower percentages of preterm birth and low birth weight.

Work continued on human microbiome (aka: healthy gut bacteria) research, and further investigation is underway on the impact of cesarean birth and infant gut bacteria colonization, and the potential benefits of artificially transferring mother’s bacteria to baby.

What other groundbreaking maternal infant topics do you feel made a big leap in 2014?  Share the topic and any relevant links in our comments section.

About Cara Terreri

cara headshotCara began working with Lamaze two years before she became a mother. Somewhere in the process of poring over marketing copy in a Lamaze brochure and birthing her first child, she became an advocate for childbirth education. Three kids later (and a whole lot more work for Lamaze), Cara is the Site Administrator for Giving Birth with Confidence, the Lamaze blog for and by women and expectant families. Cara continues to have a strong passion for the awesome power and beauty in pregnancy and birth, and for helping women to discover their own power and ability through birth. It is her hope that through the GBWC site, women will have a place to find and offer positive support to other women who are going through the amazing journey to motherhood.

ACOG, Childbirth Education, Evidence Based Medicine, Guest Posts, Lamaze International, New Research , ,

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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