Archive for June, 2009

The Maternity Conundrum: One Thing Atul Gawande Doesn’t Get About Health Care Reform

June 28th, 2009 by avatar

If you’ve been paying any attention to the health care reform conversation in this country, you’ve probably heard of a certain New Yorker article, in which physician Atul Gawande pays a visit to McAllen, TX, the town now infamous for having the most expensive health care in America. With truly exemplary investigative reporting, Gawande explores the factors that have driven the soaring health care costs in McAllen and presents a strong case that this increased spending has not improved the health of the people living there. In fact, he argues, it may be making them sicker. If you haven’t already read the article, please do.

Atul Gawande is not only a world-renowned surgeon and best-selling author, he’s also a MacArthur “Genius Grant” recipient. And rightly so. Among his many other achievements, his analysis of the health care “cost conundrum” is brilliant. So brilliant that President Obama has reportedly made it required reading among his staffers and advisers. I knew the article was something serious when prominent medical blogger Kevin Pho professed on his Twitter feed, “If you only read one health policy article in your lifetime, this one is it.”

I devoured all 8,000 words of it. But, to my astonishment, I found not a single mention of maternity care, despite the fact that hospital charges for maternal and newborn care far exceed those for any other condition, and the clear evidence that there is ample room for cost containment and quality improvement. I wondered how this article got researched, written, and published with such a glaring omission.

Then I remembered something. There’s another article Atul Gawande wrote, this one devoted to maternity care.

In his 2006 article, How Childbirth Went Industrial, Gawande follows a woman — a doctor herself — in labor with her first child. She begins the process hoping for a healthy birth with the least intervention possible. She ends with an epidural, pitocin augmentation, and eventually a cesarean section of her healthy baby after labor fails to progress. Gawande uses this all-too-common story as a backdrop to follow the history of modern obstetrics and to illustrate that, while evidence documents the harms of the routine or liberal use of many obstetric interventions, the “package” of high-tech maternity care nonetheless is responsible for the steep declines in maternal and neonatal deaths we’ve seen since the dawn of obstetrics. Along the way, he argues that broad improvements in maternity care were only possible by reining in the wide variations in obstetric practice that were once commonplace, such as the differences across doctors in the skill and safety with which they performed forceps-assisted deliveries or managed difficult vaginal breech births. Reducing this variation, he contends, required a shift from the “obstetric arts” that were difficult to teach and master consistently to a more measurable, standardized brand of obstetrics. The lamentable but worthwhile result was a rise in the use of cesarean surgery which, according to Gawande and those he interviewed, is “easy to teach,” “comfortable” for obstetricians, can be performed “consistently,” and is a “simpler, more predictable way to intervene.” Today, cesarean surgery is used to accomplish one out of every three births in the United States. (For those interested, Henci has done a more detailed critique of this article.)

Gawande acknowledges cesarean’s risks:

Straightforward as these operations are, they can go wrong. The child can be lacerated. If the placenta separates and the head doesn’t come free quickly, the baby can asphyxiate. The mother faces significant risks, too. As a surgeon, I have been called in to help repair bowels that were torn and wounds that split open. Bleeding can be severe. Wound infections are common. There are increased risks of blood clots and pneumonia. Even without any complication, the recovery is weeks longer and more painful than with vaginal delivery. And, in future pregnancies, mothers can face serious difficulties. The uterine scar has a one-in-two-hundred chance of rupturing in an attempted vaginal delivery. There’s a similar risk that a new baby’s placenta could attach itself to the scar and cause serious bleeding problems. C-sections are surgery. There is no getting around it.

And yet, he concludes, “In the next decade or so the industrial revolution in obstetrics could make cesarean delivery consistently safer than the birth process that evolution gave us.” How do we reconcile Gawande’s cogent plea to curb our over-dependence on medical technology with such a claim?

Granted, one article looks historically while the other comparatively. In How Childbirth Went Industrial, Gawande asks how we wound up with this current style of maternity care. In The Cost Conundrum, he compares McAllen to El Paso, where the population is similar, the costs are lower, and the outcomes are superior. But How Childbirth Went Industrial completely misses the same issues so ably analyzed in The Cost Conundrum even though they were staring Gawande in the face. He gets what is going on in McAllen but not what is going on with U.S. obstetric management, namely that other care models result in better outcomes and that obstetric management is driven by economic self-interest.

If Gawande wanted to do some McAllen-style journalism on maternity care, he could have visited Miami-Dade County, Florida, where more babies are born by cesarean than vaginally and one hospital has a 70% cesarean rate. He could have compared costs and outcomes in Dade County with those in, say, one Indian Health Service hospital in New Mexico, where the c-section rate in births at or beyond 35 weeks is below 10%, despite much higher rates of diabetes, pregnancy-induced hypertension, and medically-indicated induction of labor compared with national statistics. (While he was in the neighborhood, he could have checked out excellent outcomes in the rural area nearby where two-thirds of women give birth in a maternity hospital without any surgical or anesthesia facilities at all.) If he was feeling adventurous, he could have crossed the pond to virtually any European country and found lower per-capita costs, far better outcomes, and much less reliance on surgical obstetrics. Not coincidentally, he might also have noticed that had he sat down for dinner with the system’s gate-keepers abroad, as he did with six doctors in McAllen, this time he would have dined mostly with midwives. That’s because in countries with the best outcomes, midwives far outnumber obstetricians, whose specialist expertise and surgical skills are reserved for complicated and high-risk cases.

Gawande saw a fall over time in perinatal and maternal mortality and attributed it to advances in hospital-based obstetrics. But he knows as well as anyone that correlation is not the same as causation. While a few medical advances — oxytocics and ergot derivatives to control hemorrhages, antibiotics to treat infection, and surfactant to treat respiratory distress in premature infants — have certainly prevented deaths, much of the fall in mortality likely comes from basic improvements in public health and hygiene. By looking through the bifocal lenses of medicine and history, Gawande makes an erroneous assumption that, when it comes to giving birth, more technology is inherently better. What he fails to ask is the very question at the heart of The Cost Conundrum: could we get the same or even better outcomes with fewer risky and costly procedures?

So, to all you White House staffers, policymakers, and reform advocates out there, allow me to help answer this question. If you only read two health policy articles in your lifetime, make the second one this.

Milbank Report: Evidence-Based Maternity Care: What It Is and What it Can Achieve

Read this!

Research for Advocacy , , ,

The Labor Environment: “Many things that count cannot be counted”

June 23rd, 2009 by avatar

The June 2009 issue of Birth contains the results of a pilot study gauging the effects of modifying the labor room to encourage mobility, reduce stress and anxiety, and discourage routine medical intervention. Investigators randomly allocated 62 healthy women in spontaneous labor to either a modified room or the standard labor room. Women attended by midwives or doulas were excluded from participating, effectively creating a study population not predisposed to be mobile in labor.

Changes to the labor environment were relatively modest. The most radical innovation was to remove the labor bed, replacing it with a portable double-sized mattress and pillows in the corner of the room on the floor. The investigators noted that the bed is a major reason for lack of mobility. Its prominence conveys that it is the appropriate place for laboring women, and a woman in bed offers ready access for interventions, an observation backed up by research. (Both Listening to Mothers surveys reported that few women were mobile after hospital admittance. In the first survey, two-thirds of the women gave as a reason that they were “connected to things” and more than one-quarter said they were “told not to walk around.”) Rooms were also equipped with a birth ball, a chair that promoted sitting upright or leaning forward, an LCD projector with a selection of movies of calming nature images, an mp3 player with a selection of music, and a chart illustrating upright labor and birth positions. All labor rooms had a private bathroom and lacked windows. No nursing alterations were made other than mandating intermittent auscultation, leaving the overhead light off, keeping the door closed, and putting a sign on it asking people to knock before entering.

The trial was too small to draw firm conclusions, but the results certainly support conducting a larger one. Sixty-six percent of the women in the modified room reported spending less than half of their time in labor in bed versus 13% of women in the standard room, and only 35% spent three-quarters or more of their time in bed versus 87% of women in the standard room. (The bed was brought back at the woman’s – mostly for epidural analgesia – or caregiver’s request.) Women in the modified room were significantly less likely to have oxytocin augmentation (40% vs. 68%), and those who had it got it later in labor. Women also had somewhat shorter labors on average and longer times to initiation of analgesia/anesthesia. Before you get too excited at the effect on hospital-based management, though, overall, only 75% of this ultra-low-risk population—18 of whom had prior births—had spontaneous vaginal births. The cesarean rate was 11%, and 15% of women having vaginal birth had instrumental deliveries. Assignment to the modified room made no difference. Women liked the modified room and made use of its features. Interestingly, some nurses and doctors noted that the atmosphere affected them positively as well. Staff disapproval was an obstacle, however. Twenty percent recommended putting the bed back, a few disliked the room or felt it was unsafe, resistance to change was a problem in one of the two participating hospitals, and three hospitals declined to participate.

What is the “science” lesson here? Randomized controlled trials normally test by exposing participants to a specific intervention while trying to hold all other factors constant. So, for example, past trials of mobility in labor assigned women to walk or not, or to assume a particular position or not. But effective labor care cannot be reduced to a set of rules. It may be a calming and enabling environment that supports moving freely rather than a particular position or movement that affects labor progress. In addition, labor progress will be impacted by the messages, covert and overt, women receive from their environment and those who attend them. Conventionally designed trials, however well-constructed, executed, and intentioned, will inevitably fail at assessing benefits of physiologic care because they do not take these factors into account. Indeed, they are specifically designed not to. By refreshing contrast, the investigators in this pilot trial understood that they needed to take a systems approach. They created an environment that offered new possibilities and gave women freedom to engage with it, which the women did, benefitting thereby. Still, even in this study, one wonders what results investigators might have gotten had women had additional amenities such as deep tubs, access to the outdoors, and natural light, and even more important, had their caregivers all been trained in, and encouraging of, practices that promote effective labor.

Hodnett, E. D., Stremler, R., Weston, J. A., & McKeever, P. (2009). Re-conceptualizing the hospital labor room: The PLACE (Pregnant and Laboring in an Ambient Clinical Environment) pilot trial. Birth, 36(2), 159-166.

Additional Sources:
Declercq, E., Sakala, C., Corry, M. P., & Applebaum, S. (2006). Listening to Mothers II: Report of the Second National U.S. Survey Of Women’s Childbearing Experiences. New York: Childbirth Connection.

Declercq, E., Sakala, C., Corry, M. P., Applebaum, S., & Risher, P. (2002). Listening to Mothers: Report of the First National U.S. Survey of Women’s Childbearing Experiences. New York, NY: Maternity Center Association.

Title quotation from:

Jadad, A. R., & Enkin, M. W. (2007). Randomized controlled trials: Questions, answers and musings (2nd ed.). Oxford: Blackwell Publishing.

A Fancy Maternity Bed (featuring a laboring woman who seems just to be getting in the way)

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Flip Flop: How we (or at least Canada) went to routine cesarean for breech and back again in the era of evidence-based medicine

June 18th, 2009 by avatar

The media is reporting that the Society of Obstetricians and Gynaecologists of Canada (SOGC) no longer recommends routine cesarean when the baby is presenting breech at term. The new clinical practice guideline entitled “Vaginal Delivery of Breech Presentation” concludes that “vaginal delivery is reasonable in selected women with a term singleton breech fetus.”

Automatic cesarean for breech has been the international standard of care since the results of the Term Breech Trial (TBT), a multicenter, randomized controlled trial of over 2,000 women that was designed to “give the option of vaginal breech delivery its best, and perhaps last, chance to be proven a reasonable method of delivery.” That chance appeared to be dashed with the release of the trial’s findings, which seemed to suggest that vaginal breech birth posed unacceptable risks to the baby. The results included:

  • combined stillbirth and neonatal mortality rate excluding lethal congenital abnormalities: 0.3% in the planned c-section group vs. 1.25% in the planned vaginal group
  • combined perinatal mortality and serious neonatal morbidity: 1.6% in the planned c-section group vs. 5.0% in the planned vaginal group
  • no differences in maternal mortality or morbidity between groups

There has not been another randomized controlled trial of term breech birth since the TBT. So in the absence of any new “Level 1 evidence,” what explains SOGC’s new endorsement of vaginal breech birth and their commitment to retrain their obstetric and midwifery workforce to ensure the option remains a safe one? The journey to routine cesarean and back provides an important lesson in the nuances of evidence-based medicine. Let’s take a look at how the evidence has unfolded.

First, over the months and years following the trial’s publication, a flurry of responses poured in from clinicians and researchers around the world, pointing to flaws and irregularities in the trial, suggesting that labor care in some of the trial hospitals was not optimal, and claiming a failure of adequate peer review by The Lancet, the journal that had fast-tracked it to publication. (These problems are summarized in Henci Goer’s critique, When Research is Flawed: Planned Vaginal Birth versus Elective Cesarean for Breech Birth.) Cracks in the evidence were already appearing.

Then, after two years, the TBT research team tracked down the trial participants and reported long-term health outcomes. This new data revealed that almost all of the babies with severe morbidity after birth in both trial groups survived without any long-term neurological compromise, and differences in combined mortality and morbidity between the cesarean and vaginal groups had disappeared. The new SOGC Guidelines note:

With the limitations in the TBT, women had a 97% chance of having a neurologically normal two-year old, regardless of planned mode of birth. Those randomized to a trial of labour had a 6% absolute lower chance (or 30% relative risk reduction) of having a two-year-old child with unspecified medical problems, suggesting some lasting benefit of labour to the newborn immune system.

Meanwhile, several large non-randomized studies were released, consistently reporting excellent outcomes of planned vaginal breech birth. The largest, a prospective cohort study four times the size of the TBT, compared outcomes of planned vaginal birth versus elective cesarean for breech in 174 French and Belgian hospitals. There was no difference in perinatal mortality (0.08% vs. 0.15%) or serious neonatal morbidity (1.6% vs. 1.45%) between planned vaginal and planned cesarean birth. While not randomized, this robust and well designed study provided strong evidence that the risks of vaginal breech birth can be minimized in modern obstetrical units that adhere to rigorous practice standards for care in breech labor and birth.

The growing body of research set the stage for a new policy, but SOGC’s change of heart was clearly also influenced by a vocal and persistent group of consumers and clinicians who pushed back against routine cesarean for breech. A few brave doctors and midwives saw the TBT results not as a dictum about whether breech vaginal birth is safe, but as an invitation to study how it could be made safer. They also recognized the ethical problems inherent in coercing women to accept the risks of surgery in exchange for little if any benefit to their infants, and lamented the hoops women must jump through to obtain a safe vaginal breech birth in the post-TBT era.

This story is still unfolding. We do not yet know if the change in guidelines will translate to a meaningful change in practice, or for that matter, whether we will see a similar guideline revision south-of-the-border. But I am heartened to see that we are moving forward from a rigid hierarchy of evidence, where randomized controlled trials – methodologically sound or otherwise – represent absolute truth and trump consumers’ rights to informed consent and refusal. In this new era of health care quality improvement, views on the intersection of evidence-based practice and consumer preference are evolving. The story of the Term Breech Trial and its aftermath reminds us that even when the landmark clinical trial is done, there is still room for more and better research and grassroots advocacy to hone our understanding of optimal practice in maternity care and ensure access to options that are safe and satisfying.

Click on the extended post for a bibliography.

Read more…

Different Methods for Different Questions, Practice Guidelines , , , ,

Deadline Today! Nominate Your Favorite Birth Blogger for the Lamaze Media Award

June 15th, 2009 by avatar

Today is your last chance to get your nominations in for The Lamaze Media Award.

Lamaze News

What The Girls Next Door Need to Know About Childbirth and Vaginas

June 14th, 2009 by avatar

Reality TV fans (not me) and readers of the Celebrity Baby Blog (OK, that’s me) may have heard that Kendra Wilkinson of The Girls Next Door “fame” is expecting her first baby this winter.  In addition to the news that Kendra’s ex, Hugh Hefner, will be the baby’s Godfather (ick!), CBB readers were treated to some early news on Kendra’s wishes for her labor and birth.

“I’m getting an epidural, everything they can give me,” she reports. “That’s the one thing I’m nervous about the most. Everything else is so fun, but I have visions of my vagina tearing, and that sucks.”

A red flag popped up when I read this. An epidural is about the last thing I would recommend to someone who was nervous about her vagina tearing. Why? Because if there is one thing that no one disputes about epidurals, it is that they increase the need for forceps- or vacuum-assisted delivery. And instrumental vaginal birth is not good for vaginas.

It seems to me Kendra wants her cake and to eat it to. Either that, or she has very unrealistic expectations of what an epidural can and cannot achieve. But Kendra shares a concern with many women (albeit, whose careers may be less wrapped up in their sexual and reproductive organs) who want to preserve their genital integrity in birth. With this in mind, I thought I’d take this opportunity to share some tips, supported by scientific research and a little common sense, on how to protect against genital tract injury in childbirth.

  1. Choose a provider with a low episiotomy rate – under 5%. Research confirms that your provider’s episiotomy rate is the single strongest predictor of whether you will have one. Episiotomies, by definition, cause injury to the tissue of the vagina and perineum. They also predispose women to severe injuries that involve the anal sphincter. A large body of research tells us that midwives use episiotomy less than doctors do, but there is much variation in episiotomy use across midwives, too, so it’s best to ask.
  2. Choose a provider who rarely uses a vacuum or forceps. In studies of first-time mothers, the rate of instrumental vaginal delivery in women without epidurals has been reported to range from 4-60%. This huge variation can only be explained by factors that have nothing to do with women and babies (arbitrary time limits, the provider’s attitudes, etc.). If instrumental assistance is needed to get the baby born safely, choose a vacuum rather than forceps.
  3. Give birth off your back and follow your own pushing urges. Studies show that giving birth on your back and “purple pushing” can increase the chance of an instrumental vaginal birth, an episiotomy, or both. Letting someone push on your abdomen while you give birth (fundal pressure) increases the chance that a tear will extend into the anal sphincter muscle.
  4. Avoid continuous electronic fetal monitoring unless there is a good medical reason for it. It increases the chance of instrumental vaginal birth.
  5. And again, plan to give birth without an epidural because of the much higher risk of instrumental vaginal delivery that comes along with an epidural. If you do have an epidural, wait for an hour or longer after you are fully dilated to begin pushing, unless a strong urge develops sooner. This practice of “laboring down” decreases the chance of instrumental vaginal delivery and reduces the likelihood and severity of lacerations. It’s also safer for babies.

I’ve said it before and I’ll say it again: epidurals may make coping with labor pain easier, but they often make labor itself much more difficult. The urge to push may be decreased, delayed, or absent. And epidurals increase the chance that a baby will settle into the pelvis facing toward the mother’s front or side (occiput posterior or transverse), which makes it much harder to push the baby out. If a baby gets stuck in this position, a vaginal birth is very difficult to achieve and if the baby does come out vaginally, a severe laceration is likely. Women who want epidurals must be told of these trade-offs, and women who want to optimize their chance of a safe vaginal birth with minimal or no tearing must be given the full range of pain relief options and care that maximizes comfort to reduce the need for epidurals.

As for what women or providers can do proactively to avoid genital tract trauma, the research here has come up rather short. Whether the provider has her hands on the perineum or not, whether lubricants or warm compresses are used, and whether the woman performs perineal massage prenatally all have minimal if any effect. One approach that was found to be statistically associated with a reduction in trauma is birthing the baby’s head between contractions. A team of midwifery researchers in New Mexico reported this finding and concluded the following:

To deliver the fetal head between uterine contractions requires a joint effort by the mother and her clinician to achieve a slow and controlled expulsion of the baby, requiring patience and effective communication from the clinician. In these data, a calm and unrushed approach to vaginal birth improved the health of new mothers by lowering overall trauma rates and reducing the need for suturing. (Albers 2006, p. 99)

This reinforces points #1 and #2 above: Choose your provider wisely.

Still not convinced? Or think that a c-section is the answer? Childbirth educator, Mamarama, gives the straight talk on that myth. Hat-tip to A Much Better Blog for passing on the link.

Click on the extended post to see a bibliography.  Read more…

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