Patient-Choice Vaginal Delivery?

We agree that research is clearly needed to determine the relative maternal and neonatal morbidity of cesarean vs. vaginal delivery. The research efforts need careful design to ensure that the outcomes are applicable to diverse populations. Drs Lee and D’Alton, as well as the NIH consensus conference on maternal request cesarean delivery (1) , remind us of the need to use an intention to treat analysis when comparing outcomes of planned primary elective cesarean delivery with vaginal birth. Intention to treat analysis places the outcomes of women attempting vaginal delivery and subsequently having a cesarean delivery in the vaginal delivery group. As cesarean delivery after labor appears to have higher rates of maternal morbidity than successful vaginal delivery or planned cesarean, study outcomes will be very sensitive to the rate of cesarean in labor. We have wide discrepancies in current cesarean delivery rates between maternity care providers, hospitals and geographic areas. A woman is much more likely to have a cesarean delivery in New Jersey (35%) than a woman residing in New Mexico (21%) (2). Ironically, women laboring in maternity care settings with high rates of in-labor cesarean may appear to benefit from primary elective cesarean solely due to the avoidance of urgent cesarean with its inherent potential for greater morbidity. Benefit is less likely in settings in which the in-labor or emergency CS rate is low.

Studies comparing primary elective cesarean to vaginal birth will likely be cohort trials because of the unwillingness of women to be randomized with regard to route of delivery. The comparison group for a cohort study of primary elective cesarean delivery should not be current routine obstetric practice. The attempted vaginal delivery group should be a best-practices model in which women are cared for by providers with low in-labor cesarean rates, as justified by an evidence-based approach to labor management. The best practices would include avoiding elective induction in nulliparous women with an unripe cervix (3) , deferring cesarean delivery for dystocia unless at least 4 hours have passed without cervical change (4) , and low rates of episiotomy and forceps to minimize anal sphincter lacerations (5) . Ideally, intermittent rather than continuous fetal monitoring would be used: the effect of continuous electronic fetal monitoring on the CS rate has been well documented.

Long-term outcomes including the effect on future pregnancies must be considered in research comparing routes of delivery. The NIH conference counseled against primary elective cesarean delivery when “several” children are planned due to the increased risk due of repeat cesarean and placenta previa/accreta (6,7) . Unfortunately, the intention to limit family size often does not universally become a reality in the Untied States, where 50% of pregnancies are unplanned (8).

ACOG released a revised committee opinion this week on Mode of Term Singleton Breech Delivery, based on the long-term outcomes of the Term Breech Trial and European cohort studies (9). The revised recommendations now state, “Planned vaginal delivery of a term singleton breech fetus may be reasonable under hospital-specific protocol guidelines for both eligibility and labor management.” This stands in contrast to the prior recommendation that “planned vaginal delivery of a term singleton breech is no longer appropriate.” The revised ACOG Committee opinion also states “The decision regarding the mode of delivery should depend on the experience of the health care provider. Cesarean delivery will be the preferred mode of delivery for most physicians because of the diminishing expertise in vaginal breech delivery.” We are now in the unfortunate situation of defaulting to routine cesarean for breech because most physicians abandoned their vaginal breech delivery skills after the short-term results of the Term Breech Trial. Let’s avoid additional interventions without data clearly demonstrating benefit. I agree fully with Drs Lee and D’Alton that we must commit to a comprehensive research effort regarding maternity care outcomes: this must occur prior to adopting maternal choice cesarean as the newest unproven obstetrical intervention.

Larry Leeman MD, MPH University of New Mexico

References

1. National Institutes of Health State-of-the-Science Conference Statement: Cesarean Delivery on Maternal Request March 27-29, 2006. Obstet Gynecol. 2006 Jun; 107(6): 1386-97.

2. Martin JA, Hamilton BE, Sutton PD, Ventura SJ, Menacker F, Munson ML. Births: final data for 2003. Natl Vital Stat Rep 2005; 54(2): 1-116.

3. Vrouenraets FP, Roumen FJ, Dehing CJ, van den Akker ES, Aarts MJ, Scheve EJ. Bishop score and risk of cesarean delivery after induction of labor in nulliparous women. Obstet Gynecol 2005; 105(4): 690-7.

4. Rouse DJ, Owen J, Savage KG, Hauth JC. Active phase labor arrest: revisiting the 2-hour minimum. Obstet Gynecol 2001; 98(4): 550-4.

5. Eason E, Labreque M, Wells G, Feldman P. Preventing perineal trauma during childbirth: a systematic review. Obst Gynecol. 2000;95:464-71.

6. Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, et al. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32

7. Getahun, Darios, Oyelese, Yinka, Salihu, Hamisu M., Ananth, Cande V. Previous Cesarean Delivery and Risks of Placenta Previa and Placental AbruptionObstet Gynecol 2006 107: 771-778

8. Finer LB, Henshaw SK. Disparities in unintended pregnancy in the United States, 1994 and 2001, Perspectives on Sexual and Reproductive Health, 2006, 38(2):90–96.

9.Mode of term singleton breech delivery. ACOG Committee Opinion No. 340. American College of Obstetricians and Gynecologists. Obstet Gynecol 2006; 108:235–7.

Competing interests:   None declared

Cesarean Delivery: a choice, a demand, or a request?

Young Mi Lee, MD and Mary E. D’Alton, MD

There is no question that cesarean delivery on maternal request is the topic of much recent discussion and that debates are only expected to increase with time. In this issue, Leeman and Plante voice the concern that many healthcare providers fear: a rise in use of a surgical procedure before research yields answers. Current consensus is lacking on the terminology for elective cesareans performed in the absence of obstetrical or medical indications: patient choice, patient demand, or patient request? The surgery is the same but the philosophy and ethics behind each differ. A mother may request a cesarean, but it is the caregiver who must use their knowledge of medicine and the patient to provide guidance. The decision should respect both the patient’s autonomy and the provider’s obligation to optimize the health of both the mother and the fetus (1).

The authors argue that in this debate, a woman’s right to choose a vaginal delivery is not addressed. Utilizing the intent-to-treat principle is vital when approaching this question, as a woman cannot “choose” a vaginal delivery. An expecting mother may choose a planned or attempted vaginal delivery, but one can never guarantee its success. Currently, 29.1% of American women deliver by cesarean including a substantial portion of those who attempt vaginal birth (2). Ethical principles argue that a provider is not obligated to offer the option of cesarean to all patients, a sentiment echoed in the recent National Institutes of Health sponsored state-of-the-science conference on cesarean delivery on maternal request (1, 3). In addition, caution should be made in extrapolating from previous studies as none exist, to our knowledge, comparing the optimal groups of cesarean by maternal request and planned vaginal delivery.

In the case of vaginal birth after cesareans (VBAC) and vaginal breech deliveries, these are becoming increasingly rare. Influencing factors include the desire to avoid potentially catastrophic perinatal outcomes and the inability of many facilities to meet ACOG’s recommended guidelines regarding available staff and support for VBAC (4). Two important points should be considered. First, that a growing number of graduates do not obtain sufficient training or experience in complicated vaginal deliveries such as breech or forceps deliveries, thereby limiting the opportunity to do either. Second, that while there is valid concern for maintaining the option for VBAC trials, if a cesarean is not performed for the first pregnancy, the question of VBAC versus repeat cesarean is obviated for the following pregnancy.

While there is some guidance we can offer women considering whether or not to request a cesarean, there are major information gaps. There is no excuse for inadequate information about the most commonly performed major abdominal surgery today. A comprehensive, nationwide research effort must be undertaken to more precisely understand the risks and benefits, for both mother and child, of cesarean delivery by maternal request as compared to both planned vaginal delivery and to medically advised cesareans. We owe the women and children of this nation nothing less.

References:

(1) Minkoff H, Chervenak FA. Elective primary cesarean delivery. N Engl J Med. 2003 Mar 6;348(10):946-50.

(2) Hamilton BE, Marin JA, Ventura SJ, Sutton PD, Menacker F. Births: Preliminary Data for 2004. National vital statistics reports, Vol 54, No 8. December 29, 2005.

(3) National Institutes of Health State-of-the-Science Conference Statement: Cesarean Delivery on Maternal Request March 27-29, 2006. Obstet Gynecol. 2006 Jun;107(6):1386-97.

(4) American College of Obstetricians and Gynecologists. Vaginal Birth After Previous Cesarean Delivery. ACOG Practice Bulletin No 54. Washington DC, July 2004.

Competing interests:   None declared

Thank you to Drs. Leeman and Plante for this thoughtful Reflection.

The rapidly increasing cesarean rate has not improved commonly measured patient outcomes. In this same issue of the Annals of Family Medicine Zweifler et al on a large 1996 through 2002 California study of the Birth Statistical Master Files were used to identify 386,232 California residents who previously gave birth by cesarean delivery and had a singleton birth planned in a California hospital.(1) They show neonatal and maternal mortality rates did not improve despite increasing rates of repeat cesarean delivery during the years after the ACOG 1999 VBAC guideline revision. Women with infants weighing > or =1,500 g encountered similar neonatal and maternal mortality rates with VBAC or repeat cesarean delivery.

Following up on Dr. Klein's thoughts, in this month's Am J Obstet Gynecol Cyr relates that an RCT on this topic requires a hypothesis that is testable in the real world: it should be simple, specific, and stated in advance.(2) On those grounds, there is no direct way to test the hypothesis that there is an ideal cesarean section rate. Because the cesarean rate is calculated post-hoc, it is also impossible to design a prospective trial comparing specific cesarean rates. Conceptually, one might set up a large RCT with multiple arms, each having a different proportion of women by intended method of delivery, eg, 100% elective cesarean versus 0% planned vaginal birth, 80/20, 50/50, etc. For specified outcome variables, an ideal cesarean rate could then be estimated retrospectively. It is clear that the ideal rate will depend on which women are studied, and how much weight is given to maternal versus fetal morbidity—all subjective criteria.

It is my hope that others will listen to the thoughtful approach of researchers like Drs. Leeman and Plante and perform the RCTs that Drs. Cyr and Klein suggest. Those RCTs should factor in both the short and long term outcomes. As it is now, the decision on the mode of delivery is weighed just as heavily on the vagaries of the patient's relatives airline reservations, as it is on the risk of life threatening hemorrhage from placenta percreta.

References 1.) Zweifler J, et al Vaginal birth after cesarean in California: before and after a change in guidelines. Ann Fam Med. 2006 May-Jun;4(3):228-34.

2.) Cyr RM. Myth of the ideal cesarean section rate: commentary and historic perspective. Am J Obstet Gynecol. 2006 Apr;194(4):932-6.

Competing interests:   None declared

Yesterday, prompted by the thoughtful reflections of Leeman and Plante,(1) I responded to the issue of restriction of choice of mode of birth by assessing the impact of the recent NIH Conference on “Cesarean Section on Maternal Request.” I summarized some of the key recommendations and expressed concern about the implications for physiologic birth practice. Today the final summary and recommendations of that Conference were published online and by Obstetrics and Gynecology(2) Yesterday I said that we had successfully managed to derail the recommendation that an RCT be mounted to compare planned cesarean section (CS) with planned vaginal birth. Today the final report states: “The feasibility of a randomized trial should be explored.”

Yesterday I stated that the Conference recommended that women planning more than one birth should be counseled to avoid preemptive CS. Today the recommendation states that women intending to have only one or two children need not worry about excess complications from CS on request. Specifically the recommendation states: “Given the risk of placenta previa and accreta increase with each cesarean delivery…cesarean delivery on maternal request is not recommended for women desiring several children.” Today in the same journal we find another in a long series of studies that show conclusively the progressive risk of placentation problems with each successive CS.(3)

Yesterday I pointed out that, because the science was considered incomplete, the door had been opened wide to allow CS on maternal request. Today it is clear that throughout the recommendations, the risks of vaginal birth are emphasized while the risks of CS are minimized. For example, while obesity carries risks regardless of mode of birth, the door is opened for CS on request for this indication. As well, a range of accepted indications in the psychological domain are allowed in the guise of individualizing care. Shared decision-making is presented as a process that could lead to a decision for CS, outside of conventional indications, so long as undefined ethical principles are followed.

Today I note that Lancet is about to publish a very large study showing that throughout Latin America, those countries with increasing CS rates, elective and non-elective, controlling for maternal morbid conditions, demonstrating that increasing CS rates resulted in increasing maternal and perinatal complications.(4) Meanwhile it has long been clear that ever higher primary CS rates have not led to any improvement in overall neonatal outcomes.(5)

What a difference a day makes!

1. Leeman LM, Plante LA. Patient-Choice Vaginal Delivery? Ann Fam Med 2006;4(3):265-268. 2. National Institutes of Health State-of-the-Science Conference Statement: Cesarean Delivery on Maternal Request March 27-29, 2006. [Editorial]. Obstetrics & Gynecology June 2006;107(6):1386-1397. 3. Silver RMMD, Landon MBMD, Rouse DJMD et al. Maternal Morbidity Associated With Multiple Repeat Cesarean Deliveries. [Article]: Obstetrics & Gynecology June 2006;107(6):1226-1232. 4. Villar J, Valladares E, Wojdyla D et al. Caesarean delivery rates and pregnancy outcomes: the 2005 WHO global survey on maternal and perinatal health in Latin America. The Lancet 2006;In Press. 5. Foley ME, Alarab M, Daly L et al. Term neonatal asphyxial seizures and peripartum deaths: lack of correlation with a rising cesarean delivery rate. American Journal of Obstetrics & Gynecology 2005;192(1):102-108.

Competing interests:   None declared

As Dr Weinstein correctly points out, escalation of intervention does not reliably improve outcome.

As to why family medicine physicians would be willing to participate in obstetrics, given the potential for bad outcomes, we note that, although the majority of births in this country are attended by OBGYNs, family physicians and midwives still account for a significant number of births, especially in rural areas. Unfortunately, the number of family physicians willing to take on this burden has declined.(1) It is not clear, however, that obstetricians have stepped up efforts to provide care in underserved areas in order to compensate. The obstetrician co-author continues to be grateful for the role that family physicians and midwives provide in delivering obstetrical care. We can only hope that non-OBGYN maternity care providers will be less susceptible to pressures for cesarean on demand.

1. Nesbitt, TS. Obstetrics in family medicine: can it survive? J Am Board Fam Pract 2002; 15: 77-79

Competing interests:   None declared

On March 27-29 2006 The NIH hosted a Conference on “State-of-the Science: Cesarean Delivery on Maternal Request. The problem was that there is no data on such requests, only that cesarean sections (CS) were rising 1 suggesting forces at play to consider CS as just another birth.

The Conference was preceded by a systematic review, relying on data incapable of separating out planned CS from planned vaginal birth (they called it “attempt at vaginal birth”). The reviewers failed to study data on the adverse consequences for mothers who would have more than one birth in the presence of a uterine scar—including acreta/ previa/abruption/ectopics/infertility, bowel obstruction from adhesions in subsequent pregnancies.

The reviewers failed to appreciate that most of the data on pelvic floor functioning (bowel, bladder and sexual) was short-term and relatively minor. Even at three months postpartum, the incidence of severe urinary incontinence (UI) [enough to wear a pad] is equivalent by mode of birth, 2 and by two years postpartum, even for the more difficult vaginal breech birth, there was no difference for UI or baby outcomes.3

Finally the reviewers/presenters failed to appreciate that the literature reviewed came from conventional medical sources, where non- physiological birth was likely the norm. They ignored the midwifery literature. This had the effect of comparing something that obstetricians know how to do well, CS, with something done with variable skill, supporting women in physiological birth (avoidance of routine and early epidural analgesia [which raises the CS rate],4 avoidance of lithotomy position, prolonged coached closed glottis pushing and routine episiotomy.) Had this literature had been studied, the already narrow pelvic floor differences would have narrowed even more.

Those attending the Conference derailing attempts to conduct an RCT of panned vaginal birth vs planned elective CS (what kind of women would join such a trial?) and succeeded in promoting the recommendation that any woman planning to have more than one birth be advised against electing CS—because of problems of placentation etc in subsequent pregnancies. But the overall recommendation was that the science was too weak to make a recommendation; hence practitioners should operate within ethical principles, opening the door wide to elective CS in the absence of indications. The Conference was discouraging for family doctors and proponents of physiological birth. As the authors of this commentary have so clearly demonstrated, rational choices of mode of birth are being foreclosed. Vaginal childbirth is being turned into an extreme sport.

1. DECLERCQ E, MENACKER F, MACDORMAN M. Rise in "no indicated risk" primary caesareans in the United States, 1991-2001: cross sectional analysis.[see comment]. BMJ 2005;330:71-2. 2. KLEIN M, KACZOROWSKI J, FIROZ T, HUBINETT M, JORGENSEN S, GAUTHIER R. Urinary and sexual outcomes in women experiencing vaginal compared with cesarean births. J Obstet Gynaecol Can 2005;27:313-320. 3. HANNAH ME, WHYTE H, HANNAH WJ, et al. Maternal outcomes at 2 years after planned cesarean section versus planned vaginal birth for breech presentation at term: The international randomized Term Breech Trial. American Journal of Obstetrics and Gynecology 2004;191:917. 4. KLEIN MC. Does epidural analgesia increase the rate of cesarean section? Can Fam Phys 2006;52:419-421.

Competing interests:   None declared