Department of Community Health Sciences, Aga Khan University, Karachi, Pakistan.
BMC Med. 2013 Oct 3;11:215. doi: 10.1186/1741-7015-11-215.
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.
This 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.
Despite 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.
This 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.
ClinicalTrials.gov NCT01073488.
低收入国家的胎儿和新生儿死亡率至少比高收入国家高 10 倍。这些差异与获得产科和新生儿护理的机会有限以及护理质量差有关。
本试验检验了这样一种假设，即医疗保健提供者、管理人员和当地居民组成的团队可以解决获得优质产科和新生儿护理机会有限的问题，并导致干预地区与对照地区相比围产期死亡率降低。在五个低收入国家和一个中等收入国家的七个地理区域中，大多数地区的围产期死亡率较高，且有大量家庭分娩，我们对一揽子干预措施进行了一项基于群组的、未设盲的、非随机对照试验，该干预措施包括以生育计划和医院转运为重点的社区动员、社区助产士在问题识别方面的培训以及医疗机构工作人员在处理产科和新生儿急症方面的培训。主要结局是妊娠 28 周以上或出生体重≥1000g 的围产期死亡率。
尽管在每个干预区域的所有地点都进行了广泛的努力，但在主要结局或任何次要结局上，干预组和对照组之间没有差异。两组的平均围产期死亡率均为 40.1/1000 例分娩（P=0.9996）。在项目的最后六个月、干预停止后的一年，以及在最好地实施干预措施的群组中，两组之间的结果也没有差异。
这项基于群组的、全面的、大规模的、多部门干预措施并未对所提出的结局产生可察觉的影响。虽然这并不能否定这些干预措施的重要性，但我们预计，要改善这些环境中的妊娠结局，需要比试验期间这些地点现有的更多的产科和新生儿护理基础设施，而没有这些基础设施，提供者培训和社区动员将是不够的。我们的研究结果突出表明，在随机试验中评估结果至关重要，因为本应有效的干预措施可能并不有效。
ClinicalTrials.gov NCT01073488。
