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Update on Spin Doctoring Misoprostol (Cytotec): Unsafe at Any Dose

May 10th, 2010 by Henci Goer Henci Goer

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.

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The NIH VBAC Consensus Conference: Will It Pave the Road to Hell with Good Intentions?

March 6th, 2010 by Henci Goer Henci Goer

First the good news: based on the presenters, it looks like the NIH VBAC conference will be a great improvement over the elective cesarean surgery travesty of four years ago. The conference seems likely to provide solid, evidence-based information on for whom and under what circumstances VBAC is safest and most likely to end in vaginal birth. Objective, unbiased information on these points is sorely needed, as illustrated by this 2008 response by ACOG vice president Dr. Ralph Hale, who one would expect to know better, to a plea to make VBAC more available:

VBAC is potentially an extremely dangerous procedure for both mother and infant. Although 98% of women can potentially have a successful VBAC, in two percent of cases the result can be a rupture of the old scar. If this happens, then death of the baby is almost certain and death of the mother is probable. Even if the mother does not die, virtually 100% will lose their child bearing ability. To prevent these disasters, the ability to perform immediate surgery is critical.

In point of fact, with appropriate care the scar rupture rate can be 0.5% or less (6,13,15), not 2%, and the chance of the baby dying as a result of scar rupture is 5% (9), not “almost certain.” As for the mother, women rarely die or have hysterectomies, but both are more common with elective repeat cesarean than planned VBAC (3,17,18,19).

Before we break out the champagne, though, consider this: nowhere in the program is any acknowledgement of a patient’s fundamental right to refuse surgery. Quite the opposite. The background statement is rife with the language of doctors giving (or withholding) permission:

For most of the 20th century, once a woman had undergone a cesarean . . ., many clinicians believed that all of her future pregnancies required delivery by cesarean as well. However, in 1980 a National Institutes of Health Consensus Development Conference panel questioned the necessity of routine repeat cesarean deliveries and outlined situations in which VBAC could be considered.

Even more telling, VBAC is positioned as a patient and provider “preference.” The background section uses this term as does the title of the session on obstetric decision making, and Anne Lyerly, the obstetrician speaker on VBAC ethics, is co-author of the commentary “Mode of delivery: toward responsible inclusion of patient preferences.”

The problem with patient preference is that it is readily trumped by provider preference. If VBAC is no more than a menu option, the danger in determining who makes a good candidate and what constitutes optimal circumstances for VBAC is that it legitimizes its opposite: doctors and institutions denying VBAC to women they don’t think make the cut or where they don’t think safety for VBAC is adequate. (The latter, BTW, is spurious. Emergencies occur in non VBAC labors. If a hospital isn’t safe for a VBAC labor, then it isn’t safe for any woman to labor there. Not to mention that ACOG guidelines for labor induction and American Society of Anesthesiologist guidelines for epidurals require the ability to perform an urgent cesarean because of the potential for just such emergencies, but no one is setting strictures on these procedures [1,2].)

A secondary danger of the “preference” perspective is that conference presenters may treat non-clinical factors such as “medico-legal concerns” and “economic considerations” as valid reasons for VBAC refusal instead of obstacles that must be overcome. This would leave us where we are now with obstetricians and hospitals free to do as they choose, and what they choose is no VBACs. A 2005 survey found that more than half the women wanting a VBAC were denied that option, a 2009 survey of 2850 hospitals revealed that half of them had a ban or de facto ban against VBAC, and Lord knows we do not need any more stories like Joy Szabo’s.

To give the conference planners and presenters their due, normally, it makes perfect sense to limit procedures to those with the skill to perform them and require their performance in environments with adequate resources. It makes sense as well as to allow providers and institutions to decline performing them. But VBAC is the exception because it is not a procedure. Labor is what inevitably happens at the end of pregnancy. Refusing VBAC means forcing women to agree to major surgery they neither want nor need in order to obtain medical care.

Depriving a woman of choice on grounds of the baby’s safety, the primary clinical rationale for VBAC denial, values the child over the mother. This is not hyperbole. According to studies of a large U.S. population, the maternal risk of death (3 per 10,000) with elective repeat cesarean is in the same ballpark with the risk of the baby dying subsequent to scar rupture during a VBAC labor (1 per 10,000) (13,19). Moreover, as the conference will discuss, a woman undergoing repeat cesarean not only runs the risks of that surgery, but an increasing risk of placental attachment abnormalities in any future pregnancies as she accumulates surgeries, abnormalities that threaten both her life and that of the fetus. By contrast, once a woman has a VBAC, she will almost always continue to have uneventful VBACs in future pregnancies. VBAC denial is the sole instance where doctors feel justified in compelling one person to undergo a medical procedure to benefit another party, but no ethical principle or law allows this, including when the beneficiary will otherwise surely die, which is far from the case with VBAC.

Failure to recognize that VBAC is a right has another consequence as well. If you start from this premise, it follows that a key question will be how best to promote safe vaginal birth in women desiring VBAC, but this is missing from the agenda. My researches for the VBAC chapter of the new edition of Obstetric Myths turned up much food for thought on this issue. For example, a study on the large U.S. population mentioned above reported scar rupture rates of 9 per 1000 with labor augmentation and 10 per 1000 with induction but only 4 per 1000 in women laboring spontaneously (13). If every woman had labored without stimulation, 63 women would have had scar ruptures instead of 124. On the other hand, a study reported equally low scar rupture rates in induced labors (3 per 1000) as in labors with spontaneous onset (16), which suggests that while spontaneous labor is optimal, women who truly require induction can be induced without excess risk provided clinicians pay proper attention to patient selection and induction protocol. Research also shows that physiologic care substantially increases VBAC rate and reduces scar rupture rate (15). The birth center VBAC study reported a VBAC rate of 81% in women with no prior vaginal birth, 9 to 20 more women per 100 than among similar women in nine studies (4,5,7,8,10-12,14,20) who had conventional obstetric management. The scar rupture rate overall was a mere 2 per 1000.

We rightly should applaud any effort that helps women and clinicians decide between planned VBAC or repeat cesarean but lament any attempt to curtail a woman’s right to refuse surgery, be it on clinical or nonclinical grounds. VBAC is a right, not a preference, a right, let me add, not abrogated by the clinician’s opinion of its wisdom. It does not matter if you, me, and everyone on the planet were to line up and say to a woman VBAC is a bad idea in your case, she still has the right to say “no” to surgery. Clinicians and institutions must be brought to accept their ethical and professional obligation to provide best practice care to every woman wanting planned VBAC. If the conference fails in this task, then whatever it accomplishes, it will fall short of its duty to childbearing women with previous cesareans.

1. ACOG. Induction of labor. ACOG Practice Bulletin No 107 2009.

2. ASA. Guidelines for regional anesthesia in obstetrics. 2007. (Accessed 2/12/2010, at http://www.asahq.org/publicationsAndServices/standards/45.pdf.)

3. Blanchette H, Blanchette M, McCabe J, et al. Is vaginal birth after cesarean safe? Experience at a community hospital. Am J Obstet Gynecol 2001;184(7):1478-84; discussion 84-7.

4. Cahill AG, Stamilio DM, Odibo AO, et al. Is vaginal birth after cesarean (VBAC) or elective repeat cesarean safer in women with a prior vaginal delivery? Am J Obstet Gynecol 2006;195(4):1143-7.

5. Caughey AB, Shipp TD, Repke JT, et al. Trial of labor after cesarean delivery: the effect of previous vaginal delivery. Am J Obstet Gynecol 1998;179(4):938-41.

6. Chauhan SP, Martin JN, Jr., Henrichs CE, et al. Maternal and perinatal complications with uterine rupture in 142,075 patients who attempted vaginal birth after cesarean delivery: A review of the literature. Am J Obstet Gynecol 2003;189(2):408-17.

7. Gonen R, Barak S, Nissenblat V, et al. The outcome and cumulative morbidity associated with the second and third postcesarean delivery. Am J Perinatol 2007;24(8):483-6.

8. Goodall PT, Ahn JT, Chapa JB, et al. Obesity as a risk factor for failed trial of labor in patients with previous cesarean delivery. Am J Obstet Gynecol 2005;192(5):1423-6.

9. Guise JM, McDonagh M, Hashima JN, et al. Vaginal birth after cesarean (VBAC) Report/Technology Assessment No. 71. Rockville, MD: Agency for Healthcare Research and Quality; 2003 March 2003. Report No.: AHRQ Publication No. 03-E018.

10. Gyamfi C, Juhasz G, Gyamfi P, et al. Increased success of trial of labor after previous vaginal birth after cesarean. Obstet Gynecol 2004;104(4):715-9.

11. Hendler I, Bujold E. Effect of prior vaginal delivery or prior vaginal birth after cesarean delivery on obstetric outcomes in women undergoing trial of labor. Obstet Gynecol 2004;104(2):273-7.

12. Kwee A, Bots ML, Visser GH, et al. Obstetric management and outcome of pregnancy in women with a history of caesarean section in the Netherlands. Eur J Obstet Gynecol Reprod Biol 2007;132(2):171-6.

13. Landon MB, Hauth JC, Leveno KJ, et al. Maternal and perinatal outcomes associated with a trial of labor after prior cesarean delivery. N Engl J Med 2004;351(25):2581-9.

14. Landon MB, Leindecker S, Spong CY, et al. The MFMU Cesarean Registry: factors affecting the success of trial of labor after previous cesarean delivery. Am J Obstet Gynecol 2005;193(3 Pt 2):1016-23.

15. Lieberman E, Ernst EK, Rooks JP, et al. Results of the national study of vaginal birth after cesarean in birth centers. Obstet Gynecol 2004;104(5 Pt 1):933-42.

16. Locatelli A, Regalia AL, Ghidini A, et al. Risks of induction of labour in women with a uterine scar from previous low transverse caesarean section. BJOG 2004;111(12):1394-9.

17. Loebel G, Zelop CM, Egan JF, et al. Maternal and neonatal morbidity after elective repeat Cesarean delivery versus a trial of labor after previous Cesarean delivery in a community teaching hospital. J Matern Fetal Neonatal Med 2004;15(4):243-6.

18. McMahon MJ, Luther ER, Bowes WA, Jr., et al. Comparison of a trial of labor with an elective second cesarean section. N Engl J Med 1996;335(10):689-95.

19. Spong CY, Landon MB, Gilbert S, et al. Risk of uterine rupture and adverse perinatal outcome at term after cesarean delivery. Obstet Gynecol 2007;110(4):801-7.

20. Turner MJ, Agnew G, Langan H. Uterine rupture and labour after a previous low transverse caesarean section. BJOG 2006;113(6):729-32.

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Her Survival Was a “Christmas Miracle,” but the Disaster Was Man-Made

January 2nd, 2010 by Henci Goer Henci Goer

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.

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Does Progesterone Treatment Prevent Preterm Birth? A Case of “Skim Milk Masquerades as Cream”

November 11th, 2009 by Henci Goer Henci Goer

This is off my usual beat, but a relative asked me to investigate progesterone treatment to prevent preterm birth. In her first pregnancy, membranes ruptured at 31 weeks and the baby was born a week later. (The baby was fine thanks to her mother taking good care of herself in pregnancy, steroids to mature her lungs, and her mother’s colostrum and breastmilk.) Pregnant for the second time, this woman had been told that progesterone injections would be given weekly beginning at 20 weeks to prevent a second occurrence. Being a member of my family, she wasn’t quite so willing as the average pregnant woman to automatically agree to this plan.

ResearchBlogging.orgI started with the Cochrane Database of Systematic Reviews, the granddaddy of systematic review collections and a highly respected source. (A systematic review is a study of studies. Reviewers collect and analyze research on a specific issue using prespecified criteria. If the studies are sufficiently alike, statistical techniques can be used to pool their data.) The Cochrane had a review current as of 2008 that included four trials of progesterone treatment for women who had a preterm birth in a prior pregnancy. Progesterone was administered either as weekly injections or as a daily vaginal suppository, depending on the trial. Here is what the study summary said:

Progesterone was associated with a statistically significant reduction in the risk of preterm birth less than 34 weeks’ gestation (one study; 142 women; risk ratio (RR) 0.15; 95% confidence interval (CI) 0.04 to 0.64); [and] preterm birth less than 37 weeks’ gestation (four studies; 1255 women; RR 0.80; 95% CI 0.70 to 0.92).

For those of you unaccustomed to interpreting statistical lingo, let me translate: The reviewers’ statistical analysis revealed that compared with untreated women, one small study found that treated women were much less likely to deliver before 34 weeks’ gestation, and when data in four studies were pooled, women were somewhat less likely to deliver before 37 weeks’ gestation (the demarcation for full term). In neither case does the CI (confidence interval) cross one, which means differences between groups was probably not due to chance. In other words, progesterone treatment appears to be highly effective. The reviewers also found no short-term or longer-term differences in adverse outcomes for mother or child, but deemed the body of evidence on safety inadequate primarily because there is only one small follow-up study of 274 children. (We’ll come back to this study in a minute.)

This sounded extremely promising, but appearances can be deceiving. I knew that the Cochrane rules for conducting a systematic review do not capture all the possible problems with an individual trial, and reviewers, however well-intentioned, unconsciously will bring their biases along with them. Accordingly, I decided to get the four trials and evaluate them myself. A very different picture emerged when I did:

Trial #1 was published in 1975 and included only 43 women. I wasn’t able to get a copy of it, but we can ignore it as it didn’t contribute much to the review’s conclusion.

Trials #2 and #3 were published in 2003, and when I was searching for the papers, I found they had been critiqued in a commentary by Marc Keirse. Dr. Keirse is one of the authors of the bible of evidence-based maternity care, Guide to Effective Care in Pregnancy and Childbirth, and a professor at an Australian medical school. I verified his criticisms with my own copies of the two trials.

Trial #2 took place in Brazil. It was a vaginal suppository trial of progesterone versus placebo in 157 women. Dr. Keirse pointed out a number of serious problems that indicated that the investigators either did not know how to analyze their data properly or deliberately manipulated the statistics to get the “right” answer. Chief among them is that investigators collected data on 157 women, even though they had calculated before the trial that 90 women would be sufficient, and getting all 157 participants involved collecting data for a full two years longer than planned. One reason they might have done this is that their findings were not statistically significant when they reached 90 participants, so they kept collecting data until differences emerged (a process that is not ethical in research). This is akin to flipping a penny as many times as it takes for “heads” to show up with the desired frequency. Also important, investigators excluded women from the results if they had a preterm birth for reasons other than spontaneous preterm labor, mostly (10 of 15 cases) for preterm rupture of membranes. But preterm birth is preterm birth. If the study was supposed to determine whether progesterone prevented it, those women should not have been excluded. Add them back in, and the gap between treatment and placebo groups closes.

Trial #3 was of weekly progesterone versus placebo injections. It was carried out at 19 U.S. medical centers and included 463 women. This trial was conducted and reported properly; however, Dr. Keirse points out that the difference between groups was not because progesterone treatment reduced preterm births. Preterm birth rates in the treatment group were identical with that anticipated in women not having treatment based on an earlier study of similar women conducted at hospitals in the same medical center network. The difference lay in women in the placebo group having much higher preterm birth rates than anticipated. Furthermore, the theory behind administering progesterone is that it will prevent contractions, but similar percentages in both groups made hospital visits for preterm labor and tocolytic therapy. It seems that whatever was going on, progesterone wasn’t preventing preterm birth.

Investigators in trial #3 also noted an adverse effect not considered in the Cochrane review: the weekly injections were painful and could result in soreness, swelling, and bruising. This would be trivial if progesterone injections prevented preterm birth, but does it?

Trial #4 was published after Dr. Keirse’s critique. This trial, so far as I can judge, was a well-conducted international multicenter trial of progesterone in vaginal suppositories. The largest trial, it included 659 women allocated to either progesterone gel or placebo. It reported no difference in rate of preterm births (42% progesterone vs. 41% placebo), preterm labor, or any other adverse outcomes.

The follow-up study, of 194 treated children and 84 untreated children (the trial allocated to groups on a 2 to 1 basis) from trial #3 at around age 4, is too small to detect differences in uncommon adverse effects. Even if the study were big enough, age 4 is far too young to evaluate potential effects on sexual maturation and reproductive capacity. We should not be complacent about the safety of exposing fetuses to weeks of excess levels of a sex hormone. Keirse points out that the use of another hormone confidently prescribed to pregnant women, DES, became notorious for causing devastating effects in the offspring. The damage did not become apparent until children reached their teens, but continues to severely impact the health of the grandchildren of the women prescribed DES.

We’re not done yet. Had the trials shown unequivocally that progesterone treatment was effective, we do not know if their results can be generalized to all women with prior preterm birth. The trials included both women who had prior preterm births preceded by preterm labor and women whose preterm births were preceded by preterm rupture of membranes. Those situations overlap in that one can lead to the other, but the mechanism behind the two is different. In my family member’s case, rupture of membranes occurred out of the blue and was attributed to a silent infection. Leaving aside that the trials did not find that progesterone prevented preterm contractions, prior preterm labor was not her problem. How, then, even if it worked, would progesterone treatment benefit her?

My family member plans to decline progesterone treatment. Unfortunately, clinicians at her hospital and others like it will go on prescribing it in the belief that the evidence shows that it works and is harmless.

The progesterone review illustrates a general problem: Conscientious clinicians who want to practice evidence-based care cannot possibly review the research on every pertinent topic. They must rely on recommendations derived from systematic reviews, but the “black box” nature of these reviews makes it impossible to distinguish “cream” from “milk.” Until such time as systematic reviewers universally engage in critical thinking, the danger will remain as Mark Twain put it: “Researchers have already cast much darkness on the subject and if they continue their investigation, we shall soon know nothing at all.”

Citation: Dodd JM, Flenady V, Cincotta R, & Crowther CA (2006). Prenatal administration of progesterone for preventing preterm birth. Cochrane database of systematic reviews (Online) (1) PMID: 16437505

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Does It? Really? “WHO Admits: There Is No Evidence for Recommending a 10-15% Caesarean Limit”

October 30th, 2009 by Henci Goer Henci Goer

This is the title of a Medical News Today piece, actually a re-posting of a press release from a coalition of websites that promote elective cesarean surgery. The press release claims that the 2009 edition of the WHO’s “Monitoring Emergency Obstetric Care: A Handbook”  has rescinded its 1985 recommendation that cesarean rates not exceed 10-15%. Can this be true? Not so much.

In fact, not at all.

The handbook still reads, as it always has:

WHO chart

The press release goes on to state that the WHO “updated” its (actually unchanged) recommendation, “admitting” that, quote, “no empirical evidence for an optimum percentage” exists, an “optimum rate is unknown,” and world regions may now “set their own standards.” The material from the WHO handbook is accurately quoted so far as it goes, but it doesn’t go very far. The handbook goes on to say: “A growing body of research shows . . . a negative effect of high rates,” cites studies in support of this (see below), and continues, “It should be noted that the proposed upper limit of 15% is not a target to be achieved, but rather a threshold not to be exceeded. Nevertheless, the rates in most developed countries and in many urban areas of lesser-developed countries are above that threshold” [emphasis mine]. In other words, countries with rates under 15% should not be striving to increase their rates, and countries “setting their own standards” means determining optimal rates, which may vary, within the WHO range.

This brings us to the second flat out untruth: The press release states that rates above the 10-15% range recommended by the WHO “have not led to a concomitant rise in maternal mortality or foetal, perinatal and neonatal mortality.” The WHO supports the 15% upper limit precisely because cesarean rates above the 15% ceiling result in higher maternal and perinatal death and morbidity rates. Here are the studies they cite:

Deneux-Tharaux (2006)
This French study determined maternal deaths directly attributable to cesarean surgery by excluding women with risk factors that could lead to the need for cesarean surgery and reviewing the confidential reports generated after each maternal death. “After adjustment for potential confounders, the risk of postpartum death was 3.6 times higher after cesarean than after vaginal delivery. . . . Knowledge of the causes of death associated with this excess risk informs contemporary discussion about cesarean delivery on request.” The analysis, moreover, undercounts cesarean-related deaths because investigators excluded deaths that might have arisen from complications that occur more often in women with prior cesarean surgery, including ectopic pregnancy and deaths from hemorrhage due to placenta previa, placental abruption, and placenta accreta.

MacDorman (2006)
Investigators in a U.S. study found that after isolating an ultra-low-risk population with no indication for cesarean, babies born after cesarean surgery were 1.8 times more likely to die than babies born after vaginal birth. This amounted to an excess of about 1 per 1000. They conclude: “Understanding the causes of these differentials is important, given the rapid growth in the number of primary cesareans without a reported medical indication.”

Villar (2006)
A report on Latin America derived from a WHO 2005 survey of maternal and perinatal health, it found that “Rate of caesarean delivery was positively associated with . . . severe maternal morbidity and mortality, even after adjustment for risk factors. Increase in the rate of cesarean delivery was associated with an increase in fetal mortality rates and higher numbers of babies admitted to intensive care for 7 days or longer even after adjustment for preterm delivery. Rates of preterm delivery and neonatal mortality both rose at rates of caesarean delivery of between 10% and 20%.” In other words, 15% is a liberal and probably overly generous maximum.

Shame on whoever is behind these websites for circulating such dangerous misinformation—but even more shame on Medical News Today for passing it on without spending two minutes to fact check its accuracy.

In this video from the Lamaze Video Library, Eugene Declercq, PhD, fact checks claims about the rates of perinatal mortality, maternal mortality, and cesarean surgery in the United States. Special thanks to Orgasmic Birth for sharing this DVD Extra with Lamaze International.

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