JMIR Publications

ABSTRACT

Background:

Despite most births in Mali occurring in health facilities, a substantial number of newborns still die during delivery and within the first 7 days of life, mainly due to existing training deficiencies and the challenges of maintaining intrapartum and postpartum care skills.

Objective:

This trial aims to assess the effectiveness, and cost-effectiveness, of an intervention combining clinical audits and low-dose high-frequency (LDHF) in-service training of health care providers and community health workers in reducing perinatal mortality.

Methods:

The study is a three-arm cluster RCT in the Koulikoro region, in Mali. The unit of randomization are each of 84 primary care facilities. Each trial arm will include 28 facilities. The facilities in the first intervention arm will receive support in implementing mortality and morbidity audits followed by one-day LDHF training biweekly, for 6 months. The health workers in second intervention arm (28 facilities), will receive a refresher course in Maternal, Newborn and Child Health (MNCH) for 10 days in a classroom setting, in addition to mortality and morbidity audits and LDHF hands-on training for 6 months. The control arm, also with 28 facilities, will consist solely of the standard MNCH refresher training delivered in a classroom setting. The main outcome are perinatal deaths in the intervention arms compared to the control arm. A final sample of approximately 600 deliveries per cluster is expected, for a total of 30,000 newborns over 14 months. Data sources include both routine health records and follow-up household surveys of all women who recently gave birth in study facility 7 days post-delivery. Data collection tools will capture perinatal deaths, complications and adverse events, as well as the status of the newborn during the perinatal period. A full economic evaluation will be conducted to determine the incremental cost-effectiveness of each of the case-based focused LDHF hands-on training strategies in comparison to MNCH refresher training in a classroom setting.

Results:

The trial is completed. The recruitment begun on July 15th and data collection begun on July 23rd, 2019 and completed on November 2020. The data cleaning or analyses have begun at the time of submission of this protocol.

Conclusions:

The results will provide policy makers and practitioners crucial information on both the impact of different healthcare provider training modalities on maternal and newborn health outcomes, and how to successfully implement these strategies in resource-limited settings. Clinical Trial: ClinicalTrials.gov NCT03656237, registered on September 4, 2018.