It’s the largest study of its kind and it was supposed to save lives. According to StatNews:
It was supposed to be a breakthrough moment in global health.
Atul Gawande, the physician and writer, was applying a simple tool he championed — the checklist — to improve birth outcomes in a rural part of India with some of the world’s highest infant mortality rates.
But his closely watched study, the BetterBirth Trial, has produced a disappointing result: Despite increased adherence to best practices, outcomes for babies and mothers did not improve with the use of a checklist and coaching on its implementation, according to data published Wednesday in the New England Journal of Medicine.
What happened?
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Kudos to Gawande et al. for undertaking the study and especially for publishing the result that the study failed.[/pullquote]
Tl/dr version: They changed process, but they didn’t save lives. Why? Because you can’t save lives unless you medicalize childbirth with lots of C-sections.
The paper is Outcomes of a Coaching-Based WHO Safe Childbirth Checklist Program in India by Gawande and many colleagues.
The study took place in Uttar Pradesh, which has hideous rates of perinatal and maternal mortality:
Uttar Pradesh is a high-priority region for national and international public health organizations owing to its persistently high neonatal mortality (32 per 1000 live births) and maternal mortality (258 per 100,000 births). The government of Uttar Pradesh permitted the trial to proceed in 38 districts, in which we identified 320 eligible facilities. We considered a facility to be eligible if it was designated as a primary health center, community health center, or first referral unit; had at least 1000 deliveries annually; had at least three birth attendants with training of at least the level of an auxiliary nurse midwife; had no other concurrent quality-improvement or research programs; and had district and facility leadership willing to participate. The final trial sample included 120 facilities across 24 districts.
What did they do?
Studies have previously shown that, when well implemented at a small scale, the WHO Safe Childbirth Checklist improves facility-based birth attendants’ adherence to evidence-based care. We performed a large cluster-randomized trial of coaching-based implementation of the checklist (the BetterBirth program) in Uttar Pradesh, India… We hypothesized that this intervention, implemented at the facility (cluster) level, would result in a reduction in a composite outcome of stillbirth, early neonatal death, maternal death, or maternal severe complications during days 0 to 7.
In other words, they attempted to change process in order to improve outcomes. It was a failure.
We found no significant difference between intervention and control facilities in our primary outcome (15.1% in the intervention group and 15.3% in the control group; relative risk, 0.99; 95% confidence interval, 0.83 to 1.18; P=0.90) or in any secondary outcomes… We found no significant differences between the trial groups in the rates of follow-up care required for women or newborns, hysterectomy, blood transfusion, or interfacility transfer (referral) for women or newborns…
Despite being effective in changing process, no lives were saved.
Kudos to Gawande et al. for undertaking the study and especially for publishing the result that the study failed.
Although it is tempting to extrapolate the results from small scale studies to make policy (that’s pretty much the only thing that breastfeeding researchers do, for example), you don’t know if large scale interventions will work unless you try them and see.
Why didn’t it work?
Because childbirth is very dangerous and women and babies die as a result of complications, not because of provider behavior. The only truly effective way to save lives in childbirth is to medicalize it. The most important factor is easy access to C-sections.
An accompanying editorial notes:
The trial facilities were predominantly health centers, not hospitals… Moreover, the “skilled birth attendants” providing care in this trial did not necessarily have the skills necessary to save the life of a mother, fetus, or newborn. (A skilled birth attendant is often defined as having the ability to conduct a normal vaginal delivery.) In both trial groups, the birth attendant was usually a nurse; physicians performed only 14% of deliveries.
Cesarean delivery is often required to prevent maternal, fetal, or newborn death; analyses of multinational data have shown that rates of cesarean delivery of 15 to 20% are associated with the lowest rates of maternal, fetal, and neonatal death…
What can we learn from this study?
… Because many complications are not predictable, it would be ideal if all births occurred in well-equipped, well-stocked facilities with appropriately trained staff. Preeclampsia cannot be diagnosed or treated if blood pressures are not measured; fetal distress cannot be diagnosed if the fetal heart rate is not auscultated and cannot be treated if cesarean sections are not performed. Reductions in maternal, fetal, and newborn mortality require substantial organization, resources, and skills and will not happen in health systems without these features.
In other words, childbirth is dangerous and only liberal use of medical interventions saves lives.
Although the study was undertaken in the developing world, it has important implications for efforts in the industrialized world, particularly for the purveyors of natural childbirth.
1. It proves yet again that childbirth is inherently dangerous. This wasn’t childbirth in nature; it was far improved beyond that with skilled birth attendants and health facilities. Regardless, rates of perinatal and maternal mortality are hideous.
2. It calls into question the popular idea that childbirth has been “over-medicalized.”
3. It demonstrates that the two most important factors in reducing infant and child death are C-sections and obstetricians and you can’t have the former without the latter.
Reactions to the study results indicate that natural childbirth advocates routinely ignore scientific evidence. The StatNews piece included this mind boggling quote from Katy Kozhimannil, a public health researcher and natural childbirth advocate.
Sometimes when you put evidence-based practices into the world, the world is stronger than those practices.
Apparently cognitive dissonance is hard even for those who ought know better. The world isn’t “stronger” than evidence based practices; practices that don’t work in the world obviously aren’t evidence based.
The bottom line is this: childbirth is inherently dangerous. If we want to save lives we must medicalize it.
