Action leveraging evidence to reduce perinatal mortality and morbidity (ALERT): study protocol for a stepped-wedge cluster-randomised trial in Benin, Malawi, Tanzania and Uganda

Joseph Akuze, Makerere University, Kampala, Uganda.
Kristi Sidney Anerstedt, Karolinska Institutet, Solna, Sweden
Lenka Benova, nstitute of Tropical Medicine, Antwerp, Belgium.
Effie Chipeta, University of Malawi, Blantyre, Malawi
Jean-Paul Dossou, Centre de Recherche en Reproduction Humaine et en Démographie (CERRHUD), Cotonou, Benin
Mechthild M. Gross, Hannover Medical School, Hannover, Germany
Hussein Kidanto, Aga Khan University
Bruno Marchal, Institute of Tropical Medicine, Antwerp, Belgium
Helle Mölsted Alvesson, Karolinska Institutet, Solna, Sweden.
Andrea B. Pembe, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania



Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3. The majority of deaths occur during the intrapartum and immediate postnatal period. Overcoming the knowledge-do-gap to ensure implementation of known evidence-based interventions during this period has the potential to avert at least 2.5 million deaths in mothers and their offspring annually. This paper describes a study protocol for implementing and evaluating a multi-faceted health care system intervention to strengthen the implementation of evidence-based interventions and responsive care during this crucial period.

Methods: This is a cluster randomised stepped-wedge trial with a nested realist process evaluation across 16 hospitals in Benin, Malawi, Tanzania and Uganda. The ALERT intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement supported by data from a clinical perinatal eregistry and iv) empowerment and leadership mentoring of maternity unit leaders complemented by district based bi-annual coordination and accountability meetings. The trial’s primary outcome is in-facility perinatal (stillbirths and early neonatal) mortality, in which we expect a 25% reduction. A perinatal e-registry will be implemented to monitor the trial. Our nested realist process evaluation will help to understand what works, for whom, and under which conditions. We will apply a gender lens to explore constraints to the provision of evidence-based care by health workers providing maternity services. An economic evaluation will assess the scalability and costeffectiveness of ALERT intervention.