RESUMO
Background: In resource-poor settings, perinatal infections contribute significantly to maternal and neonatal deaths, and the use of clean delivery kits (CDKs) has been proposed as a tool to reduce the risk of infection-related deaths. This study aims to assess the acceptability and effectiveness of CDKs in preventing infections in deliveries attended by traditional birth attendants (TBAs) in Abeokuta, Nigeria. Methods: The study was a cluster-randomized trial with 67 birth centres/clusters, 453 births/mothers, and 457 babies randomized to intervention or control arms; intervention involved supplementation of delivery with JANMA CDKs. Interviews were conducted at the birth homes, and the primary outcomes were neonatal infection and puerperal fever. The association between infection and perinatal risk factors was tested using the Chi-square and Fisher's exact tests. Results: CDKs were well accepted by TBAs. The incidence of puerperal fever and neonatal infection was 1.1% and 11.2%, respectively. Concurrent infection was found in 1 (0.22%) of the mother-neonate pair. There was no significant association between any of the sociodemographic factors and infection for both mothers and neonates. PROM and prolonged labour were significantly associated with puerperal infection. All mothers with puerperal fever were from the control group. Compared to the control group, the relative risk of puerperal infection and neonatal infection in the intervention group was 0.08 (0.004 -1.35, p = 0.079) and 0.64 (0.37 to 1.1, p = 0.10), respectively. Conclusion: CDKs hold promising results in attenuating maternal infections in resource-poor settings. Larger studies with greater statistical power are required to establish statistically reliable information.