A Randomized Study of Birth, Complete with Ethical Dilemmas

An interesting study published in the January issue of the European Journal of Obstetrics & Gynecology and Reproductive Biology randomized 61 pregnant women with an occipitoposterior (OP, or “face up”) position during the second stage of labor to either have or not have an experienced physician or midwife attempt a digital or manual rotation of the baby into the more favorable occipitoanterior (OA) position. The researchers then looked at those two groups for how they ultimately delivered, including whether they required c-section.

The authors found that when the rotation was attempted, 77.4 percent of women had a spontaneous vaginal delivery, 22.6 percent had vacuum extraction, and none had c-section.

In those who did not have the rotation attempted, only 26.4 percent had spontaneous vaginal delivery, while 50 percent had vacuum extraction and 23.3 percent had c-section. Women in whom rotation wasn’t attempted also had higher rates of episiotomy (when they did deliver vaginally), and longer hospital stays.

It is important to note that is is a very small study, with only ~30 women in each group, and it may not adequately address significant differences in induction and epidural rates between the two groups. There are aspects that are intriguing beyond the actual results, however.

The first is that this small study represents a randomized trial of a birth-related intervention – these are relatively few and far between, given ethics-based concerns about outcomes, and a perceived unwillingness of women to have their birth experiences randomized.

In fact, the women who were enrolled in this study were not asked to sign informed consent forms. The authors report, “Since manual/digital rotation of POP is an accepted optional obstetric maneuver practised by some but not all obstetricians, the Institutional Review Board of our center deemed that signed informed consent was unnecessary.”

In other words, since some providers attempt rotation and some don’t, they didn’t find it necessary to explicitly have women consent to participation.

I wonder, given the finding of increased c-section, whether it will be difficult to ethically conduct future studies of this practice for validation and further exploration. It might be difficult to convince another IRB agree to a lack of informed consent for a larger study (and we can certainly question whether they should).

Likewise, women who are informed may be unwilling to agree to be randomized when some evidence exists that they may be increasing their risk of undergoing surgery.

Would you be willing to be randomized to either have or not have an intervention during birth? What do you think about this study’s lack of explicit informed consent? Please leave your thoughts in the comments.