University of California, San Francisco, Institute for Global Health Sciences, USA.
Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya.
J Glob Health. 2022 Dec 29;12:04073. doi: 10.7189/jogh.12.04073.
A large proportion of early neonatal deaths occur at the time or on the first day of birth. The Preterm Birth Initiative East Africa (PTBi EA) set out to decrease mortality among preterm births through improving quality of facility-based intrapartum care. The PTBi EA cluster randomized trial's primary analysis showed the package reduced intrapartum stillbirth and neonatal death among preterm infants. This secondary analysis examines the impact of the PTBi intervention package on stillbirth and predischarge newborn deaths combined, among all births in 20 participating facilities in Kenya and Uganda.
Eligible facilities were pair-matched and randomly assigned (1:1) into either the intervention or the control group. All facilities received support for data strengthening and a modified World Health Organization (WHO) Safe Childbirth Checklist; facilities in the intervention group additionally received provider mentoring using PRONTO simulation and team training as well as quality improvement collaboratives. We abstracted data from maternity registers.
Of the total 29 442 births that were included, Kenya had 8468 and 6465 births and Uganda had 8719 and 5790 births, in the control and intervention arms, respectively. There were 935 stillbirths and predischarge newborn deaths in the control arm and 439 in the intervention arm. The adjusted odds ratio (aOR) for the effect of the intervention on the combined outcome, among all births, was 0.96 (95% confidence interval (CI) = 0.69-1.32), which was different by country: Kenya - 1.12 (95% CI = 0.72-1.73); Uganda - 0.65 (95% CI = 0.44-0.98); P = 0.025. These trends were similar after excluding the PTBi primary cohort.
The intervention package improved survival among all births in Uganda but not in Kenya. These results suggest the importance of context and facility differences that were observed between the two countries.
This trial is registered with ClinicalTrials.gov, NCT03112018.
很大一部分新生儿死亡发生在出生时或出生后的第一天。东非早产儿倡议（PTBi EA）旨在通过提高医疗机构内分娩期间的护理质量来降低早产儿死亡率。PTBi EA 整群随机试验的主要分析表明，该方案降低了早产儿的产时死胎和新生儿死亡。这项二次分析检查了 PTBi 干预方案对肯尼亚和乌干达 20 家参与设施中所有分娩的死产和新生儿出院前死亡的综合影响。
符合条件的设施进行配对，并随机分为干预组或对照组（1:1）。所有设施都获得了数据强化支持和经过修改的世界卫生组织（WHO）安全分娩清单；干预组的设施还接受了使用 PRONTO 模拟和团队培训以及质量改进合作的提供者指导。我们从产妇登记处提取数据。
在纳入的 29442 例分娩中，肯尼亚的对照组和干预组分别有 8468 例和 6465 例分娩，乌干达的对照组和干预组分别有 8719 例和 5790 例分娩。对照组有 935 例死产和新生儿出院前死亡，干预组有 439 例。所有分娩中，干预对联合结局的影响的调整后比值比（aOR）为 0.96（95%置信区间（CI）=0.69-1.32），这因国家而异：肯尼亚 - 1.12（95% CI = 0.72-1.73）；乌干达 - 0.65（95% CI = 0.44-0.98）；P = 0.025。在排除 PTBi 主要队列后，这些趋势仍然相似。
干预方案提高了乌干达所有分娩的存活率，但在肯尼亚没有。这些结果表明，两国之间观察到的背景和设施差异非常重要。
该试验在 ClinicalTrials.gov 注册，NCT03112018。
