Abstract
BackgroundFetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care.MethodsThis trial tested the hypothesis that teams of health care providers, administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations. In seven geographic areas in five low-income and one middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we performed a cluster randomized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g.ResultsDespite extensive effort in all sites in each of the three intervention areas, no differences emerged in the primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in the last six months of the project, in the year following intervention cessation, nor in the clusters that best implemented the intervention.ConclusionsThis cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial, and without them provider training and community mobilization will not be sufficient. Our results highlight the critical importance of evaluating outcomes in randomized trials, as interventions that should be effective may not be.Trial registrationClinicalTrials.gov NCT01073488
Highlights
Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries
A total of 70,351 pregnant women were screened in the intervention clusters and 66,830 in the
In geographic areas with high maternal and perinatal mortality in seven sites in six countries, we found that a multipronged intervention that included: 1) community mobilization and birth attendant education focusing on birth planning and transportation to a hospital; 2) birth attendant recognition of complications, stabilization and appropriate, timely referral to a hospital; and 3) hospital staff training focusing on appropriate and timely management of medical complications did not reduce perinatal mortality
Summary
Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries These differences have been related to poor access to and poor quality of obstetric and neonatal care. Complications during labor and delivery are responsible for half the maternal deaths, one-third of stillbirths and a quarter of neonatal deaths occurring each year worldwide [1,2,3,4,5,6,7,8]. Antenatal assessment often fails to predict which women will have complications and when these will occur Their effective management often necessitates urgent, facility-based management of labor by a skilled birth attendant with the ability to provide parenteral medications, carry out procedures, including blood transfusions and cesarean sections, and provide newborn care/resuscitation [4]. Programs have used various combinations of these interventions [14,15,16,17,18,19,20,21,22]; simultaneous integration of these strategies has not been adequately evaluated to determine whether in aggregate they would reduce perinatal deaths
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