Maternal and neonatal mortality rates are consistently higher in low- and middle-income countries than in high-income regions. As a result, checklists have been introduced to encourage routine adherence to evidence-based practices and improve outcomes. The World Health Organization (WHO) Safe Childbirth Checklist was developed in 2009 as a low-cost tool to improve adherence to essential practices during labor and delivery and reduce complications during childbirth. The BetterBirth Program encourages coaching-based implementation of the Safe Childbirth Checklist and has been associated with improved patient outcomes in small studies. Coaches in the BetterBirth Program are trained nurses who support birth attendants’ adherence to specific practices, including blood pressure and temperature assessments, proper hand hygiene, and early newborn care.
In this week’s issue of NEJM, Semrau and colleagues investigated the effectiveness of an 8-month BetterBirth program in facilities across Uttar Pradesh, India. With a population of over 204 million, this region is a high priority due to its persistently high neonatal and maternal death rates. The authors conducted a cluster-randomized controlled trial in 60 matched pairs of facilities across 24 districts and measured perinatal and maternal mortality, maternal severe complications, and birth attendants’ adherence to essential birth practices.
After 2 months, adherence to measured practices in a subset of observed births averaged 73% in the intervention group (1259 observed births) versus 42% in the control group (P<0.01). At 12 months (4 months after completion of the program), adherence in the intervention group decreased to 62% of practices per childbirth, but remained significantly higher than in the control group (44%; P<0.01). However, the primary outcome (a composite of perinatal/maternal mortality and maternal severe complications within the first 7 days) did not differ significantly between the two groups (15% in both groups; P=0.90).
The authors note that the observation of births at nonrandomly selected centers is a potential study limitation that may contribute to the discordant findings between adherence to the safety checklist and patient outcomes. If staff practices during unobserved births were measurably different, the results are not fully representative. In an accompanying editorial, Drs. Goldenberg and McClure suggest that evaluation of the intervention in health centers rather than hospitals with resources to provide life-saving care and the high rate of vaginal deliveries contributed to the failure of the intervention to show improved outcomes. Cesarean sections, often life-saving procedures in childbirth, were performed in fewer than 2% of both study groups. In contrast, prior studies have reported that cesarean section rates of 15%-20% are associated with lower maternal and perinatal mortality rates.
Although implementation of the coaching-based WHO Safe Childbirth Checklist in this study increased birth attendants’ adherence to essential birth practices, these improvements failed to translate to a measurable effect on perinatal or maternal mortality or severe maternal morbidity within 7 days. Adherence to essential birth practices at intervention sites remained suboptimal even with the Checklist and deteriorated over time. These findings suggest the need for hospital-based strategies that target improved early maternal and perinatal care in low- and middle-income countries.
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Lisa is a 2017-2018 NEJM Editorial Fellow. An otolaryngologist-head and neck surgeon by training, she graduated from the University of Toronto Medical School and completed her residency training at the University of Ottawa. She has a Master's in Public Health from the Harvard T. H. Chan School of Public Health.