Effect of a quality improvement intervention for management of preterm births on outcomes of all births in Kenya and Uganda: A secondary analysis from a facility-based cluster randomized trial

Background 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 de-crease 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 in-fants. This secondary analysis examines the impact of the PTBi intervention pack-age on stillbirth and predischarge newborn deaths combined, among all births in 20 participating facilities in Kenya and Uganda. Methods Eligible facilities were pair-matched and randomly assigned (1:1) into ei-ther 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 mento-ring using PRONTO simulation and team training as well as quality improvement collaboratives. We abstracted data from maternity registers. Results 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 con-trol arm and 439 in the intervention arm. The adjusted odds ratio (aOR) for the ef-fect 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); Pinteraction= 0.025. These trends were similar after excluding the PTBi primary cohort. Conclusions The intervention package improved survival among all births in Ugan-da but not in Kenya. These results suggest the importance of context and facility dif-ferences that were observed between the two countries. Registration This trial is registered with ClinicalTrials.gov, NCT03112018.