Science & Sensibility

Last August, I argued against ACOG’s current position on inducing labor with misoprostol, which is that misoprostol is safe “when used appropriately” (p. 387), by which ACOG means provided it is used in doses no greater than 50 micrograms in women with an unscarred uterus. In March, I started work on the induction chapter for the new edition of Obstetric Myths Versus Research Realities, and I decided to see if I could find evidence that ACOG’s confidence was misplaced. I looked for reports of misoprostol catastrophes occurring in U.S. hospitals in women with unscarred uteruses who received no more than 50 microgram doses of misoprostol. I found 11 cases fitting my criteria. Two were single case reports: a uterine rupture leading to hysterectomy in a woman induced solely with two 25 microgram vaginal doses of misoprostol, and a uterine rupture leading to stillbirth and hysterectomy in a woman induced solely with one 25 microgram vaginal dose. The other nine were reported in a case series of severe adverse events following misoprostol induction vaginally or, in one case, orally. All nine women experienced uterine hyperstimulation, which in seven cases was reported as accompanied by severely abnormal fetal heart rate, meconium, or both. The nine cases of hyperstimulation resulted in a total of two cases of uterine rupture, five cases of permanent fetal neurologic injury, two perinatal deaths, and three maternal deaths. One woman with uterine rupture experienced disseminated intravascular coagulation, a life-threatening consequence of severe hemorrhage, and three women had diagnoses of amniotic fluid embolism (AFE). The AFE cases resulted in a maternal death, a maternal death and a brain injured child, and a maternal and perinatal death among the mother-baby pairs. We probably have a twelfth case in comment #17 to the original blog post, but not enough information is given to be sure. (Maddy Oden also posted a comment, but Tatia Oden French’s case is the third of the three AFE cases reported in the case series, a case, by the way, in which Maddy tells me that the coroner’s report mentions AFE but lists the cause of maternal death as “natural causes: cardiac arrest.”)

We’re not done yet. I also ran across a study comparing 95 pre-eclamptic women undergoing pre-induction cervical ripening with vaginal misoprostol with 108 women having ripening with prostaglandin E2. Among women receiving misoprostol, 18% had cesareans for fetal heart rate abnormalities, A.K.A. fetal distress, versus 8% of those having prostaglandin E2, and 14% having misoprostol experienced placental abruption (the placenta detaches partially or completely before delivery) versus 2% receiving prostaglandin E2. So it isn’t just women with cesarean scars who are at especially high risk with misoprostol inductions but women with severe hypertension as well.

I don’t know about you, but if there were a compelling medical reason why I needed labor induced—and most inductions do not fall in this category—and the situation was, moreover, of such concern that induction could not wait for cervical readiness to labor, I would insist on using some means other than misoprostol.

Henci Goer Uncategorized case reports, induction, misoprostol, safety

The Institute for Healthcare Improvement (IHI), the leading nonprofit organization working to accelerate change in healthcare, has been in the news this month because its CEO, Donald Berwick, was recently nominated to head up the Centers for Medicare and Medicaid Services. (For those not familiar with Berwick, read his phenomenal article, “What ‘Patient-Centered’ Should Mean: Confessions of an Extremist“). Berwick himself and IHI’s Managing Director, Sue Gullo, RN, were key players in the recent Transforming Maternity Care Project coordinated by Childbirth Connection. Now, the IHI is rolling out programs to help hospitals and health care systems implement some of the work put forth in the project’s Blueprint for Action. These initiatives also coincide with the new Joint Commission perinatal core measures which hospitals may implement as of this month. Here’s what is on offer so far:

• Earlier this month, IHI recorded Momentum for Maternity of the Safest Kind, a podcast with the Transforming Maternity Care leadership about trends in health care for pregnant women, new mothers, and newborns and the work needed to reliably provide safe and effective care, reduce disparities, and rein in costs.
• On Tuesday, May 4 from 3-4 PM ET, Sue Gullo will host a public call to discuss the IHI’s work on improving safety in second-stage labor. The call can be accessed through the IHI Webex System (Click on Improving Perinatal Care Collaborative Info Call) or via land line at 866-469-3239 (enter the session ID 354 952 217*. More information can be found on IHI’s Improving Perinatal Care page.
• A series of seven web-based sessions for hospital staff involved in quality improvement efforts will focus on the safe use of oxytocin for induction, starting with avoiding all elective deliveries before 39 weeks. The series begins May 14.

To keep up with other IHI offerings, you can follow them on Facebook or Twitter

Amy Romano Uncategorized announcements, hospitals, induction, interventions, maternity care systems, safety, second stage

The Joint Commission Sentinel Alert #44: “Preventing Maternal Deaths” is an important document and public recognition that many of the maternal deaths in the United States are preventable. However, the alert is missing important and useful information for women and childbirth educators since the recommendations in the alert are downstream approaches or recommendations for how to save a woman from dying who may have been thrown in the river. It fails to alert our healthcare system about the need to keep women out of the river in the first place.

Let me give you some examples:

One Joint Commission recommendation is to consistently use techniques that have proven effective in the prevention of thromboembolism (blood clots) in women having surgical births. Clearly it is critical that we reduce the risks of surgery and this recommendation needs to be heeded. We need to make surgical births as safe as possible. However, if we eliminated the overuse of cesarean sections we would eliminate even more deaths and injuries. Based on publicly released data, the increase of cesarean surgical intervention is related to where a woman gives birth.

Debra Bingham, DrPH, RN, LCCE

Indeed there is often as much as a three-fold variation in the number of surgical births performed at different hospitals even after adjusting for the woman’s age and risk factors. Reining in practice variation has been a focus of efforts to improve care in other healthcare specialties, yet wide and unwarranted practice variation remains a serious problem in maternity care.

So why are there so many more surgical births and such wide variation in rates of cesarean sections? Well one clear factor at work is variation in how women are treated in labor. For example, some hospitals keep women who present in early labor while other hospitals are more likely to offer supportive care to these women and encourage that they remain at home until active labor. Why is being in a hospital in early labor a problem? When a woman is in a hospital in early labor she is put in a bed, her movements are restricted, and she is tethered to a fetal monitor. None of these interventions has been shown by research to improve maternal or infant outcomes, and in fact they all have documented harms. In addition, it is normal and expected for early labor to start and stop for several days. However, if a woman is admitted to a hospital in early labor and her labor stops then she is likely to have an unnecessary induction of labor. Overuse of inductions lead to more cesarean sections. This becomes the beginning of a cascade of events that all too often leads to a surgical intervention.

Let’s move to the hemorrhage recommendations as another example. Hemorrhage remains a leading cause of death and severe morbidity despite more efforts over recent years to control blood loss at birth. Why haven’t these efforts succeeded? One reason is that as the cesarean rate rises, more pregnant women have uterine scars. The uterine scar increases a woman’s risk for abnormal placenta implantation when they get pregnant again. These abnormal placenta implantations are called percretas, accretas and previas. When a woman has placenta accreta or percreta this can lead to internal organ damage and permanent damage to her uterus because the placenta literally grows into the uterine muscle or even into her bowel and bladder and cannot detach from these organs after the baby is born. This abnormal implantation leads to hemorrhage and also often necessitates the removal of her uterus to save her life. Abnormal placenta implantations used to be very rare emergencies; they are becoming common now due to the overuse of cesarean sections. This is a trend that is frightening to me because based on the current rates of cesarean sections the number of women affected will only increase. Things are going to get much worse.

Lamaze International has issued our own “Sentinel Alert” on how to prevent maternal deaths. Lamaze’s recommendations are called the Six Healthy Birth Practices. Following these key practices will prevent women from being thrown in the river and needing to be rescued.

The critical behaviors that Lamaze recommends to improve health and safety are to let labor start on it’s own, encourage freedom of movement, offer labor support rather than labor management, avoid all routine interventions not supported by evidence, avoid interfering with a woman’s freedom to push in an upright position or any position of her choice, and keep the baby with the mother after birth.

Hospitals can help achieve the Joint Commission goal of reducing preventable maternal deaths while also making progress toward Joint Commission core measures by training staff in these practices. Lamaze International offers an Evidence-Based Nursing Care Workshop to do just that. Registration is currently open for our March workshop in Hollywood, Florida.

Debra Bingham, DrPH, RH, LCCE is President-Elect for Lamaze International, Executive Director of the California Maternal Quality Care Collaborative (CMQCC), a member of the California Pregnancy-Associated Maternal Mortality Review Committee and a lead researcher for determining how to prevent maternal deaths.

Debra Bingham Uncategorized cesarean, complications, hospitals, induction, interventions, Joint Commission, practice variation, safety

I’m going to be on Momotics Blog Talk Radio tomorrow evening at 10pm EST discussing the issue of transparency in maternity care with Danielle from Momotics. You can listen here.  For the occasion, I thought I would dig up this fact sheet I wrote for Lamaze a couple of years ago when we first got involved in advocacy on this issue.  I’ve learned a lot since then and have thought for a while that this fact sheet needs to be revised and updated. I’d love thoughts from readers, especially those involved in ongoing efforts to collect and publicize facility data for The Birth Survey. What would you change? What messages need to be more clear? What else do I need to include? Feedback, please!

Why Transparency in Maternity Care Matters: A Fact Sheet for Birth Advocates

What is Transparency?

A pregnant woman asks her care provider, “What is your episiotomy rate?” Her doctor responds, “I only do them when it is necessary.” On her tour of the hospital maternity center, another woman asks about the hospital’s cesarean rate and is told, “We take care of many high risk patients, so you can’t compare our cesarean section rate with the hospital across town.”

What are the consequences when women can’t objectively evaluate the quality of their maternity care options? How do we help women make sense of intervention rates? How can women make fair comparisons?

Transparency means providing health care consumers with the information they need – and the means to interpret it – in order to evaluate the quality of care provided by individual providers and institutions. Transparency is the missing ingredient to truly informed choice.

Are Intervention Rates Important Quality Measures?

A growing body of research shows that among the most important factors influencing a woman’s risk of obstetric interventions, especially cesarean surgery and episiotomy, are where and with whom she gives birth. A recent study of over 41,000 low-risk women having their first babies in 20 California hospitals found cesarean rates for this population ranging from 11% – 30%. Statistical analysis revealed that obstetric practices – not clinical or demographic factors – accounted for over half of the variation across hospitals (1). Two studies conducted in Washington State found that the individual physician was an independent risk factor for cesarean section in both induced and spontaneous labors (2, 3). Several studies have shown that episiotomy is more common in private obstetric practices versus public or university-affiliated practices (4-6). Rates varied from 6% to 60%, but at least one university hospital maintains an episiotomy rate of 1% (7).

Excess use of obstetric interventions, in turn, increases the likelihood that the woman or her baby will be injured, experience complications such as infection, suffer pain, or have negative birth experiences (8). So, in short, a woman who goes to a provider or hospital with a high cesarean section rate is more likely to end up with cesarean surgery – and to suffer its potential consequences. If she goes to a provider with a high episiotomy rate, she is more likely to have an episiotomy – and to suffer its potential consequences. And so on… However, in most states, maternity care providers and facilities are not required by law to publicly report intervention rates or other outcome indicators, nor to help the public interpret data that are available.

Women can not make informed choices about their maternity care if they do not have access to the information that is most likely to influence their outcomes. They can not decrease their exposure to injury from injudicious use of interventions without knowing where and with whom intervention rates are too high. Without transparency, our health care system gives women a false sense of choice.

Can Transparency Improve the Quality of Maternity Care?

Yes! While most of the research on transparency and public reporting relates to other areas of health care, a few studies have looked at maternity care in particular and have found that public reporting of intervention rates and outcomes, whether alone or in combination with other quality improvement programs, translates into better care (9-11). In fact, an experiment conducted in Wisconsin suggests that the quality of obstetric care improves more in response to public reporting than other medical or surgical specialties (9). This may have been because there was more “room for improvement” in maternity care – more hospitals had low scores on obstetric indicators than on cardiac or surgical indicators. In the same study, hospitals included in a public report were more likely than those that were not to undertake quality improvement efforts. These efforts appeared to be effective – maternity units that improved their quality scores were more likely than those that stayed the same or did worse to have begun quality improvement efforts shortly after the public report was released. In other words, public reporting prompted hospitals to work to improve the areas where they scored poorly, and these efforts were effective at improving the quality of care.

Apples and Oranges: How Do We Make Fair Comparisons?

The question of which indicators to measure and how these should be reported complicate efforts to ensure transparency in maternity care. This is particularly problematic when it comes to interpreting cesarean section rates. The overall cesarean section rate (number of cesareans divided by the number of all births) may not be comparable across settings because some hospitals take care of many high risk women while others take care of low-risk women. The rate of cesarean section in high risk women may be higher for good reason. The same is true at the provider level; some providers, including many midwives, specialize in the care of low-risk women while others care for a mixed-risk population or specialize in high risk pregnancies. Similarly, factors such as parity (whether the woman has previously given birth) and age may naturally affect rates of obstetric interventions as well as outcomes.

Healthy People 2010, the federal program that sets goals for various health indicators, measures the cesarean section rate in nulliparous women (those having their first babies), with term (>37 weeks), singleton (one baby), vertex (head down) pregnancies (12). This is abbreviated as the “NTSV cesarean rate” and is used as a proxy for the cesarean section rate in low-risk first time mothers. It has been shown to be highly sensitive to variations in obstetric practices (1), so quality improvement programs should therefore be effective at safely lowering the NTSV cesarean rate. It is also a good measure because, if we can safely prevent the first cesarean, we can prevent repeat cesareans, as well as poor pregnancy outcomes resulting from accumulating many cesarean scars, such as placenta previa, preterm birth, and placenta accreta. As advocates for improvements in maternity care, we should recognize the NTSV cesarean rate as an effective quality indicator, and should educate the public to ask for and know how to interpret NTSV cesarean rates.

However, perfect indicators that can be compared easily across birth settings and providers will not be available in every community. Even when they are, the total rates of cesarean section, episiotomy, and other interventions are important quality measures. In the case of cesarean surgery, many studies have shown that rates can safely be less than 15% in mixed-risk populations, including those where considerable proportions of women have medical problems or are at risk because of poverty, age, or other factors (8, 13, 14). So, while the likelihood of requiring a cesarean will vary with individual circumstances, women with care providers whose rates are 15% or less can trust the their practitioner’s judgment should they recommend a cesarean in their case.

How Can Birth Advocates Promote Transparency?

Ensuring transparency in maternity care will require a major shift from the status quo, with buy-in and participation from hospitals, care providers, insurance companies, government, and consumers. As advocates for mother-friendly maternity care, we can help influence transparency efforts in our communities. In some areas, transparency initiatives are well underway and mother-friendly birth advocates can work to help consumers access and make sense of publicly available information. In communities where there is resistance to transparency, advocates can work to influence legislative efforts, create consumer demand for transparency, or work with the media, hospital administrators, local opinion leaders, or others to promote change. By maintaining a focus on quality improvement and safety rather than penalizing providers or facilities, transparency advocates are likely to gain greater acceptance and involvement from key stakeholders.

References

1. Main, E. K., Moore, D., Farrell, B., Schimmel, L. D., Altman, R. J., Abrahams, C., et al. (2006). Is there a useful cesarean birth measure? Assessment of the nulliparous term singleton vertex cesarean birth rate as a tool for obstetric quality improvement. American Journal of Obstetrics and Gynecology, 194(6), 1644-51.

2. Luthy, D. A., Malmgren, J. A., & Zingheim, R. W. (2004). Cesarean delivery after elective induction in nulliparous women: The physician effect. American Journal of Obstetrics and Gynecology, 191(5), 1511-1515.

3. Luthy, D. A., Malmgren, J. A., Zingheim, R. W., & Leininger, C. J. (2003). Physician contribution to a cesarean delivery risk model. American Journal of Obstetrics and Gynecology, 188(6), 1579-85; discussion 1585-7.

4. Goode, K. T., Weiss, P. M., Koller, C., Kimmel, S., & Hess, L. W. (2006). Episiotomy rates in private vs. resident service deliveries: A comparison. The Journal of Reproductive Medicine, 51(3), 190-192.

5. Howden, N. L., Weber, A. M., & Meyn, L. A. (2004). Episiotomy use among residents and faculty compared with private practitioners. Obstetrics and Gynecology, 103(1), 114-118.

6. Robinson, J. N., Norwitz, E. R., Cohen, A. P., & Lieberman, E. (2000). Predictors of episiotomy use at first spontaneous vaginal delivery. Obstetrics and Gynecology, 96(2), 214-218.

7. Albers, L. L., Sedler, K. D., Bedrick, E. J., Teaf, D., & Peralta, P. (2005). Midwifery care measures in the second stage of labor and reduction of genital tract trauma at birth: A randomized trial. Journal of Midwifery & Women’s Health, 50(5), 365-372.

8. Goer, H., Leslie, M. S., & Romano, A. (2007). The evidence basis for the 10 steps of mother-friendly care: Step 6: Does not routinely employ practices, procedures unsupported by the scientific evidence. The Journal of Perinatal Education, 16(1 Suppl), 32-64.

9. Hibbard, J. H., Stockard, J., & Tusler, M. (2005). Hospital performance reports: Impact on quality, market share, and reputation. Health Affairs, 24(4), 1150-1160.

10. Hibbard, J. H., Stockard, J., & Tusler, M. (2005). It isn’t just about choice: The potential of a public performance report to affect the public image of hospitals. Medical Care Research and Review, 62(3), 358-371.

11. Wirtschafter, D. D., Danielsen, B. H., Main, E. K., Korst, L. M., Gregory, K. D., Wertz, A., et al. (2006). Promoting antenatal steroid use for fetal maturation: Results from the California perinatal quality care collaborative. The Journal of Pediatrics, 148(5), 606-612.

12. Healthy People 2010. (2000). Objective 16-9. reduce cesarean births among low-risk (full term, singleton, vertex presentation) women. Retrieved 7/16/2007, from http://healthypeople.gov/document/html/objectives/16-09.htm

13. Haire, D. B., & Elsberry, C. C. (1991). Maternity care and outcomes in a high-risk service: The north central Bronx hospital experience. Birth, 18(1), 33-37.

14. Leeman, L., & Leeman, R. (2002). Do all hospitals need cesarean delivery capability? An outcomes study of maternity care in a rural hospital without on-site cesarean capability. The Journal of Family Practice, 51(2), 129-134.

Amy Romano Uncategorized cesarean, episiotomy, induction, interventions, practice variation, transparency

Many of you will have read the story of the woman laboring on Christmas Eve who suddenly went into respiratory and cardiac arrest in front of her horrified husband. She recovered shortly after her son was delivered by emergency cesarean, and the baby, too, was successfully revived. As the MSNBC article tells the tale:

After their miraculous recovery, both mother and the baby, named Coltyn, appear healthy with no signs of problems, Martin [the obstetrician who responded to the Code Blue and performed the emergency cesarean] said. She said she cannot explain the mother’s cardiac arrest or the recovery. “We did a thorough evaluation and can’t find anything that explains why this happened,” she said. Mike Hermanstorfer credits “the hand of God.”

However, an ABC video interview with Tracy and Mike Hermanstorfer and Dr. Martin provides details that call into question the hospital’s failure to find an explanation. I have transcribed the relevant section.

Tracy: [Tracy was being induced for her third child because membranes ruptured.]The pains [with Pitocin] were a lot harder than I remembered. We decided to go ahead and do the epidural for the very first time. . . .

ABC: Mike, you were holding her hand as Tracy got the epidural. . . . When did you start to notice that there was a problem occurring?

Mike: Well, we had her sitting up when they were doing the epidural and afterwards she lay down and said that she was tired and that’s when the whole nightmare started.

ABC: What happened?

Mike: She started going numb and everything in her legs . . . and she laid down to close her eyes and take a little nap . . . and she wasn’t waking up.

ABC: When did you notice that her breathing was shallow or her color was blue?

Mike: Well, I felt her hand—I was holding her hand—and it started getting cold and I looked down at her fingertips and her fingertips were blue and one of the nurses noticed that the color in her face was completely gone. She was as gray as a ghost.

ABC: Code Blue was declared, a scary thing in any hospital. [Dr. Martin arrives in response.]

Dr. Martin: . . . When I ran into the room, the anesthesiologist had already started breathing for Tracy. There were preparations already being made to start a resuscitation should her heart stop. About 35 to 40 seconds after I got in the room, her heart did stop and we started making preparations to do an emergency cesarean delivery right there in the room in the event that we were not successful in bringing Tracy back. Unfortunately, in most of these situations, despite the best efforts of the team, Mom is often not able to be revived, so we anticipated that possibility and when it became clear that Tracy was not responding to all the work that the team was doing on her, we had to make that difficult decision to do the cesarean section, primarily in an effort to give Coltyn the best chance at a normal survival and also hoping that it would allow us to do a more effective resuscitation on Tracy, and fortunately, she cooperated and we got a heartbeat back immediately after delivering Coltyn.

So, according to Dr. Martin, Tracy is an example of how things can go suddenly and horribly wrong for no discernable reason in a healthy woman having a normal labor. All I can say is that Dr. Martin must have slept through the class on epidural complications. Tracy’s story is the classic sequence that follows what anesthesiologists term an “unexpectedly high blockade,” meaning the anesthesiologist injected the epidural anesthetic into the wrong space and it migrated upward, paralyzing breathing muscles and in some cases, stopping the heart. High blockade happens rarely, and even more rarely does it result in full respiratory and cardiac arrest—one database analysis of 11,000 obstetric epidural blocks reported a rate of 1 in 1400 women experiencing a high block and 1 in 5500 requiring intubation, and no woman experienced cardiac arrest. It does happen, though, and I am willing to bet that high blockade and its sequelae happened to Tracy.

The moral of the print version would be: have your baby in a hospital where you can be saved should this happen to you. The video interview, however, reveals a different picture. The real moral of the tale is that the safest and healthiest births will be achieved by avoiding medical intervention whenever possible. Induction of labor is by no means always necessary when membranes rupture and certainly not immediately. If Tracy had been allowed to start labor on her own, which, considering that this was not her first baby, she would likely have done within a few hours, she probably wouldn’t have wanted the epidural any more than she did for her first two children. Tracy almost certainly would have gone home the day after Christmas after another uneventful, unmedicated vaginal birth. Instead, she is recovering from surgery, and she and her husband have the emotional trauma of her and her son’s near miss experience to deal with. Along with the Hermanstorfers, we can thank God for the prompt actions of the hospital team, but the safe money says they were rescuing her from a disaster they themselves had caused.

Henci Goer Uncategorized complications, epidurals, induction, media, PROM