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Things are seldom what they seem. Skim milk masquerades as used to shape policy, even if it was junk. And as medical organizations grew more sophisticated about press releases and public relations, the obstetricpowers-that-be also realized that even if the study A funny thing happened on the way to practicing did not produce the results they had hoped, it didn’t evidence-based obstetric care. Obstetricians hijacked matter. If it was accompanied by an editorial, the some of the research. In the late 1970s and 1980s commenter could make any claims he or she liked advocates for change could say either that the for the study, and almost no one—few obstetricians evidence did not exist to support typical obstetric and certainly no one in the media—would notice the management or that it existed and discredited it.
Enough people made this point that governmental This exercise pulled the rug out from under birth agencies, third-party payers, and consumers began activists. It was hard enough trying to explain to an pressuring obstetricians to mend their ways. To cite unsophisticated public and clinicians that expert one example, the Healthy People goals set in 1990 opinion was insufficient without science to back it up.
mandated a reduction in the cesarean delivery rate to Convincing them that research published in respected 15 percent by 2000 (1). (It is worth noting that the medical journals might be fatally flawed or that claims National Institutes of Health convened a consensus for it were not justified is well-nigh impossible. Once conference in 1980to strategize on how to lower a misinformation is widely disseminated, a well-crafted cesarean rate that had reached the alarming heights of rebuttal has little effect. The damage is done, and the fact that the falsehood aligns with the cultural zeitgeist, Mainstream obstetricians reacted, not by bringing whereas the correction does not, ensures that it cannot their practices into line with what the research showed to be safe and effective care, but by fightingchange. In a variation of the old saw ‘‘If it looks like a duck and sounds like a duck and walks like a duck,it’s a duck,’’ they discovered that if a study read like 1. Hannah et al’s 1992 multicenter randomized a well-done study—it was laid out as such, used the controlled trial concluded only that induction of right terminology and concepts, and was published labor at 41 weeks’ gestation decreased the cesarean in a peer-reviewed journal—it would be accepted rate from 25 to 21 percent compared with expectant into the canon of evidence-based care and could be management (3). This trial was actually one ofelective induction, since pregnancy was not consid-ered postterm at that time until 42 weeks. Itsconclusion, however, contradicted the finding of Henci Goer is the author of The Thinking Woman’s Guide to a other studies of elective induction, all of which Better Birth, Obstetric Myths Versus Research Realities, and many reported substantial increases in the cesarean rate in articles on birth issues for consumers and professionals. She is a doula nulliparous women (4). Since two-thirds of Hannah and a retired Lamaze-certified childbirth educator.
et al’s population had no prior births, why the Address correspondence to Henci Goer, 970 Buckeye Court, Sunny- difference? Answer: One-third of the expectant man- vale, CA94086 or Goersitemail@HenciGoer.com.
agement group was induced, and one-third of the induction group began labor spontaneously, which would flatten out the differences between groups.
long opposed VBAC, however, and starting in 1996, A follow-up analysis revealed that, in fact, 42 percent they began producing studies purporting to support, of induced nulliparas had cesareans compared with or which editorials claim support, elective cesarean.
25 percent of nulliparas laboring spontaneously (5).
The Hannah et al trial found no differences inperinatal morbidity or mortality.
1. McMahon et al’s study concluded that, ‘‘Major complications were nearly twice as likely among Result: This trial fueled a headlong rush to induce women undergoing a trial of labor’’ (15, p 689).
labor routinely at 41 weeks’ gestation or even earlier However, the authors coded wound infections and on the grounds of improved perinatal outcomes. This hemorrhage requiring transfusion as ‘‘minor compli- cations’’ (16). These would normally be considered because 41 weeks is the median length of pregnancy major complications, and coding them as such would in healthy nulliparas, who are at high risk for have wiped out the difference. Even so, ‘‘nearly twice’’ the major complication rate amounted to alittle less than 1 percent in the elective cesarean 2. Misoprostol (Cytotec) to induce labor: After group, a little more than 1 percent in the VBAC the drug’s manufacturer, Searle, wrote a letter to all obstetricians repudiating the off-label use of Cytotec 2. Mozurkewich and Hutton conducted a meta- and the U.S. Food and Drug Administration (FDA) analysis and concluded that a trial of labor ‘‘may’’ banned its use, a review of the literature argued result in an increase in fetal and neonatal mortality that misoprostol was safe (at least in women with compared with elective repeat cesarean, despite find- unscarred uteruses) and effective, and that no other ing no statistically significant difference (12).
drug could substitute (7). An accompanying editorial They reached this conclusion despite stacking the chastised the FDA for banning it (8). Contradicting deck against trial of labor by including deaths its own conclusion, the review acknowledged that unrelated to birth route. The combined fetal and misoprostol resulted in more cases of uterine hyper- neonatal mortality rates in 11 studies totaled 136 per stimulation and accompanying fetal distress and that 23,486 (or 6 ⁄ 1000) for trial of labor versus 56 per it produced similar cesarean rates compared with 16,239 (or 3 ⁄ 1000) for elective repeat cesarean for an oxytocin or prostaglandin E2 inductions. The review absolute difference of 3 per 1000. All but 8 deaths in also omits mention of case reports of uterine rupture the former group and 3 deaths in the latter group came from 3 studies. A closer examination of those 3studies reveals that when the numbers are corrected Result: The FDA rescinded the ban, not on the by subtracting deaths unrelated to birth route, the grounds of misoprostol’s efficacy and safety, but numbers fall to 43 in the trial of labor group and 13 because it was in such common use (9). The drug’s in the elective group for a corrected mortality rate of package insert continues to state a long list of serious 2 per 1000 versus 1 per 1000 and an absolute and life-threatening complications attributed to it (10). In fact, misoprostol’s only virtues are its 3. Lydon-Rochelle et al’s study was accompanied extremely low cost—pennies per dose—and its ten- by an editorial, in which Greene asserted that the dency to throw women into short, violent labors, investigators had proved that elective cesarean sec- which allows obstetricians to practice ‘‘daylight tion was safer for babies than VBAC (17). The study obstetrics,’’ a clear case of sacrificing the best itself only showed the dangers of induction with interests of women and babies to economics and prostaglandin E2 (18). The uterine rupture rate was 1.6 per 1000 with elective repeat cesarean, 5.2 per1000 with spontaneous labor onset—only slightly VBAC versus Elective Repeat Cesarean Studies more than with planned cesarean and the same asthat found in other large studies, 7.7 per 1000 with Dozens of studies, comprising tens of thousands of oxytocin induction, but a whopping 24.5 per 1000 women, and meta-analyses of those studies have with prostaglandin E2. The study did not report conclusively demonstrated that VBAC is less hazard- comparative neonatal mortality rates, but they can be ous for the mother and equally safe for the baby calculated from the reported 5.5 percent death rate (11–14). Because 70percent or more of women can after uterine rupture: 1 per 10,000 with elective repeat give birth vaginally, a policy of routine VBAC spares cesarean, 3 per 10,000 with spontaneous labor, 4 per women and babies exposure to the risks of cesarean 10,000 with oxytocin induction, but 13 per 10,000 section in subsequent pregnancies. Obstetricians have with prostaglandin E2. The accuracy of the data must also be questioned, since 311 VBAC women had birth with a trained attendant, Pang et al claimed breech presentations or placenta previa, conditions that Washington state birth certificate data showed that would surely disqualify them from VBAC (19).
that such births increased the risk of neonatal death 4. Smith et al recommended elective cesarean at 39 and other adverse outcomes (27). The study’s many weeks on the basis of finding an 11-fold increase in flaws included failure to exclude unplanned home perinatal mortality with trial of labor (20). But the births or planned home births with no qualified study defined any vaginal birth or emergency cesarean attendant; failure to exclude preterm births; failure to after 37 weeks’ gestation as a trial of labor. Thus, any determine whether the choice to birth at home was at woman who had a uterine rupture or placental fault in neonatal deaths; failure to establish truly abruption after 37 weeks and had an emergency comparable populations; and failure to report on cesarean would be classified as a trial of labor. The adverse outcomes strongly associated with hospital perinatal mortality in such cases would likely be high.
birth in low-risk women, such as greatly increased Investigators in a large Swiss study reported that the cesarean and vaginal instrumental delivery rates odds of uterine rupture in pregnancy in women with a uterine scar were 2 per 1000, the odds of placental Result: This study will almost certainly be used abruption 3 per 1000 (13). Although not every baby to justify the ongoing persecution of home birth would die, and some cases would occur earlier than 37 midwives and to put pressure on those physicians weeks, still, this means that, several, if not many, of the 20infant deaths in Smith et al’s so-called ‘‘trial oflabor group’’ were not trials of labor. In any case, theabsolute difference in mortality between planned cesarean and planned vaginal birth was 1 per 1000,and did not differ significantly from the mortality rate Problems even infest the Cochrane systematic reviews, in primiparous births. To put these mortality rates in long the gold standard of evidence-based care. They perspective, the chance of losing the pregnancy as a have crept in as the Cochrane evolved from a small result of amniocentesis is 1 in 200 to 1 in 400 (21). Yet band of upstart, radical physicians and midwives no one is suggesting abandoning amniocentesis.
challenging established practice into a mainstream The study by McMahon et al is the sole one cited in institution itself. A disturbing number of reviews support of the American College of Obstetricians and conform to the Cochrane guidelines but reach erro- Gynecologists’ (ACOG’s) about face on VBAC. These neous conclusions and misrepresent the true state of latest guidelines emphasize the risks of VBAC, say affairs. This is especially problematic because these nothing about the risks of repeat cesarean, and set reviews have the power to effect sweeping changes in standards of care for VBAC labors that many com- munity hospitals cannot meet—standards of care thatthe guidelines themselves acknowledge are not backed 1. The review Interventions for Preventing or by research (22). That ACOG singles out VBAC Improving the Outcome of Delivery at or Beyond Term labors, even though emergencies occur in non-VBAC concludes that routine induction of labor at 41 weeks labors at higher rates, suggests that the intent is to will reduce the perinatal mortality rate without eradicate VBAC, not protect the well-being of mothers increasing the cesarean rate (30). Among the 19 studies, 9 per 3800 babies died perinatally in theexpectant management group versus 1 per 4125 babies Result: Between the new ACOG guidelines and these in the routine induction group (2.3/1000 vs 0.2/1000).
studies, the VBAC rate has plunged from a high of 28 But 2 of the 9 deaths in the await-labor group percent in 1996 to a low of 16.4 percent in 2001 (24).
occurred before 41 weeks’ gestation. A policy of Thousands of women have been refused VBACs, routine induction at 41 weeks would not have including women who have already had one or more prevented them. Another 2 deaths occurred in a (25), a policy that not only contravenes an ACOG 1969 study of only 110women. This study and those Committee Opinion guaranteeing women the right to deaths can be eliminated on the grounds that the refuse any treatment, test, or procedure, but the right obstetrics of that era and the perinatal death rates of any patient to decline surgery (26).
simply do not apply to modern-day care. That leaves 5perinatal deaths in 3750women versus 1 in 40 women, or 1.3 per 1000 in the expectant managementgroup versus 0.2 per 1000 in the routine induction Contradicting the consistent findings of a large body group, or a difference of 1 per 1000 between groups. A of research affirming the safety of planned home difference this small seems likely to be due to chance.
The reviewer also fails to find a difference in researchers, peer reviewers, and editorialists assur- cesarean rates even among nulliparous women, but edly play a role. Mary Hannah, principal author of this is almost certainly because the reviewer failed to large multicenter randomized controlled trials of address crossover. Typically, 20percent or more of postdates pregnancy, prelabor rupture of mem- participants assigned to induction began labor spon- branes, and vaginal breech delivery, recently con- taneously and vice versa. In the Hannah et al trial, vened and chaired a conference entitled ‘‘Choosing one-third in each group received the other treatment, Delivery by Caesarean: Has Its Time Come?’’ (34) which is especially problematic because the size of Michael Greene, assistant editor of the New England this trial in relation to the other trials makes it Journal of Medicine, who wrote the editorial damning the ‘‘500 lb gorilla’’ in the weighted meta-analysis (3).
VBAC that accompanied Lydon-Rochelle et al’s Such a degree of crossover will greatly flatten out study, said of elective primary cesareans, ‘‘The differences in outcomes between groups.
in-laws get to use supersaver fares’’ (35). James 2. Crossover also afflicts the Cochrane reviews of Scott, who shaped ACOG’s current guidelines and is epidurals, early amniotomy, and episiotomy. To editor of Obstetrics and Gynecology, which published illustrate, the Cochrane review of episiotomy finds Pang et al’s home birth study, is on record opposing no statistical difference in severe posterior or vaginal trauma with routine versus selective use of episio- That obstetricians should be prejudiced in favor of tomy, even with midline episiotomy (31). Every study intervention in general and surgery in particular is that has ever been done has concluded that midline scarcely surprising for physicians who are, after all, episiotomy predisposes to anal tears, but in the sole surgeons and specialists in the pathology of women’s randomized controlled trial of midline episiotomy, 57 reproductive organs. Obstetric management rests on percent of primiparas and 31 percent of multiparas the erroneous premise that pregnancy and childbirth had episiotomies in the ‘‘restrict episiotomy’’ group are events fraught with peril, and require the services (32). In point of fact, 52 of 53 anal tears were of just such specialists to avert the disasters that would otherwise frequently ensue. It follows that 3. The review Vaginal Misoprostol for Cervical these who believe this will tend to exaggerate the Ripening and Induction of Labour notes ‘‘reduced dangers of the natural process and overlook the harm failure to achieve vaginal delivery within 24 hours’’ done by injudicious intervention. Belief is not amen- as an advantage of the drug in the abstract, but able to change by science, logic, or even common readers must delve into the review’s text to find sense. ‘‘My mind is made up; don’t confuse me with that misoprostol resulted in no difference in cesar- the facts’’ will do quite as well to compromise ean section rate overall when compared with research, reviews, and commentaries as financial prostaglandin E2 (33). This is a serious omission, incentives to get the ‘‘right’’ result.
given the review’s ominous findings that misopros- ACOG and its spokespeople sometimes also have tol increases the incidence of uterine hyperstimula- less innocent motives than self-deception. A promin- tion compared with other induction agents, that it ent obstetrician and the ACOG guidelines for VBAC increases the likelihood of abnormal fetal heart rate openly admit that avoiding malpractice litigation and meconium staining compared with intracervical motivates the discouragement of VBAC (22,37), prostaglandin E2, and the authors’ acknowledg- despite the ACOG ‘‘Code of Professional Ethics,’’ ment of case reports of uterine rupture with and which enjoins obstetricians to resolve conflicts of without uterine scars. The abstract gives the misim- interest in favor of what is best for the patient (38).
pression that misoprostol is a superior induction Given misoprostol’s potential for disasters and the agent, when, in fact, it is not, but it is more availability of an equally efficacious and less risky drug, this motive also appears to be the only logical These errors are not subtle. Experienced researchers reason for pressuring the FDA to rescind the ban on should know better, or failing that, peer review com- Cytotec. The ability to claim that misoprostol induc- mittees, who also should know better, should have tion meets the community standard of care protects caught the errors. That these ‘‘experts’’ did not raises obstetricians in misoprostol-related lawsuits. Another the possibility that the errors may have been intentional.
strong motivator is preserving the hegemony ofobstetric management and the power, prestige, andeconomic reward that go with it.
As scandals elsewhere have taught us, in the absence of outside oversight or restraint, the danger Why would supposed experts pass off badly done always exists that members of any occupation will act studies as sound research? The inbred biases of some in their own self-interest at the expense of those they profess to serve when the two conflict. Practitioners Reuters. FDA OKs label change for labor-inducing drug.
and the public trust that the scientific method and Reuters Health Information, Apr 18, 2002.
U.S. Food and Drug Administration. Cytotec. Access at: peer review will protect against exactly this potential http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm# and ensure that, insofar as it is possible, results reflect the truth. When those involved co-opt the process Goer H. The Thinking Woman’s Guide to a Better Birth. New and present propaganda as research, they break that York: Perigee Books, 1999:284–285.
Mozurkewich EL, Hutton EK. Elective repeat cesareandelivery versus trial of labor: A meta-analysis of the litera- In the end, motivation doesn’t matter. The ture from 1989 to 1999. Am J Obstet Gynecol 2000:183: damage is done regardless. As it stands now, reformers of obstetric management have effectively Rageth JC, Juzi C, Grossenbacher H. Delivery after previ- been silenced. Indeed, those daring to publish ous cesarean: A risk evaluation. Obstet Gynecol 1999;93: criticism of the research may even be accused of Roberts RG, Bell HS, Wall EM, et al. Trial of labor or libel or threatened with legal action (39). The repeated cesarean section: The woman’s choice. Arch Fam concept of evidence-based care has been suborned.
Those who rely on the research or interpreters of the McMahon MJ, Luther ER, Bowes WA, Olshan AF. Com- research to guide practice or assist women in parison of a trial of labor with an elective second cesarean making informed choices cannot trust that what section. N Engl J Med 1996;335:689–695.
Flamm BL. Once a cesarean, always a controversy. Obstet they read or hear is disinterested, but few of them know it. Reporters and editors who disseminate Greene M. Vaginal delivery after cesarean section—Is the risk research findings in the media unwittingly spread acceptable? N Engl J Med 2001;345:54–55.
untruths. They do not exercise journalistic skepti- Lydon-Rochelle M, Holt VL, Easterling TR, Martin DP.
cism or fact checking, because obstetric researchers, Risk of uterine rupture during labor among women with aprior cesarean delivery. N Engl J Med 2001;345:3–8.
pundits, and ACOG itself continue to carry credi- Flamm BL. Vaginal birth after cesarean and the New England bility, authority, and influence that too often they Journal of Medicine: A strange controversy. Birth 2001; The consequences of the breakdown are not Smith GCS, Pell JP, Cameron AD, Dobbie R. Risk of trivial. The financial cost is enormous, and the perinatal death associated with labor after previous cesareandelivery toll on the physical and emotional health and well-being of women and babies is appalling.
Olney RS, Moore CA, Khoury, MJ, et al. Chorionic villus Millions of women and thousands of babies have sampling and amniocentesis: Recommendations for prenatal suffered permanent injury. Some of them have counseling. MMWR Morb Mortal Wkly Rep 1995;44(RR-9): American College of Obstetricians and Gynecologists. Vagi-nal birth after previous cesarean delivery. No 5. Practice Bull Enkin M, Keirse MJNC, Neilson J, et al. AGuide to Effective U.S. Department of Health and Human Services. Healthy Care in Pregnancy and Childbirth. 3rd ed. Oxford: Oxford People 2000: National Health Promotion and Disease Preven- tion Objectives. DHHS publication no. (PHS) 91–50212.
Martin JA, Hamilton BE, Ventura SJ, et al. Births: Final data Washington, D.C.: Government Printing Office, 1990:378.
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asp?webtag=iv-ppbirthguru&msg=1526.1&ctx= 4194304 Hannah ME, Hannah WJ, Hellman J, et al. Induction of labor as compared with serial antenatal monitoring in post- Informed Refusal. Committee Opinion No. 237. Washington, term pregnancy. A randomized controlled trial. N Engl J Med Pang WY, Heffelfinger JD, Huang GJ, et al. Outcomes of Goer H. Elective induction of labor. Access at: planned home births in Washington State: 1989–1996. Obstet www.hencigoer.com/downloads/elective_induction.rtf Hannah ME, Huh C, Hewson SA, Hannah WJ. Postterm Goer H. Homebirth: Is It a Safe Option? Access at: http:// pregnancy: Putting the merits of a policy of induction of labor www.parentsplace.com/expert/birthguru/articles/0,10335, into perspective. Birth 1996;23:13–19.
Mittendorf R, Williams MA, Berkey CS, Cotter PF. The Vedam S. Home birth versus hospital birth: Questioning length of uncomplicated human gestation. Obstet Gynecol the quality of the evidence on safety. Birth 2003;30: Goldberg AB, Greenberg BS, Darney PD. Misoprostol and Crowley P. Interventions for preventing or improving the pregnancy. N Engl J Med 2001;344:38–47.
outcome of delivery at or beyond term. (Cochrane Review).
Hale RW, Zinberg S. Use of misoprostol in pregnancy. N Engl In: The Cochrane Library. Issue 2. Oxford: Update Software, Carroli G, Belizan J. Episiotomy for vaginal birth. (Cochrane Come? Conference sponsored by MIRU, University of Review). In: The Cochrane Library. Issue 2. Oxford: Update Toronto, Toronto, Ontario, Canada, Nov 7, 2002.
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Klein MC, Gauthier RJ, Jorgensen SA, et al. Relationship of Scott JR. Mandatory trial of labor after cesarean delivery: episiotomy to perineal trauma and morbidity, sexual dys- function, and pelvic floor relaxation. Am J Obstet Gynecol Phelan JP. Rendering unto Caesar cesarean decisions. OBG Hofmeyr GJ, Gulmezoglu AM. Vaginal misoprostol for cervi- cal ripening and induction of labour (Cochrane Review). In: American College of Obstetricians and Gynecologists. Code of The Cochrane Library. Issue 2. Oxford: Update Software, 2002.
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