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, Kristi Sidney Annerstedt, Lenka Beňová, Effie Chipeta, Jean‐Paul Dossou, Mechthild M. Groß, Hussein Kidanto, Bruno Marchal, Helle Mølsted Alvesson, Andrea B. Pembe, Wim Van Damme, Peter Waiswa, Claudia Hanson, ALERT Study Team, Gertrude Namazzi, Josephine Babirye, Philip Wanduru, Helle Mölsted Alvesson, Nicola Orsini, Regine Unkels, Virginia Castellano Pleguezuelo, Rian Snijders, Thérèse Delvaux, Bianca Kandeya, Razak Mussa, Samuel Meja, William Stones, Yesaya Z. Nyirenda, Ahossi Angèle Florence Laure, Antoinette Sognonvi, Armelle Vigan, Banougnin Bolade Hamed, Kéfilath Bello, Christelle Boyi Metogni, Gisèle Houngbo, Gottfried Agballa, Hashim Hounkpati, Schadrac C. Agbla, Joanne Welsh, Muzdalifat Abeid, Tumbwene Mwansisya, Fadhlun M. Alwy Al‐beity, Zamoyoni Julius, Dickson Ally Mkoka, Lilian Teddy Mselle, Beatrice Mwilike, Helga Naburi, Elizabeth Ayebare, Andrea B. Pembe, Ann-Beth Nygaard Moller, Bruno Marchal, Claudia Hanson, Effie Chipeta, Elizabeth Ayebare, Hashim Hounkpatin, P Gandaho, Hussein Kidanto, Jean‐Paul Dossou, Joseph Akuze, Kristi Sidney Annerstedt, Lenka Beňová, Lilian Teddy Mselle, Mechthild M. Groß, Peter Waiswa, Wim Van Damme, Jennifer Hall, Erik Lampa, Zahida Qureshi
Abstract
BACKGROUND: 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 e-registry 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 cost-effectiveness of ALERT intervention. DISCUSSION: There is evidence that each of the ALERT intervention components improves health providers' practices and has modest to moderate effects. We aim to test if the innovative packaging, including addressing specific health systems constraints in these settings, will have a synergistic effect and produce more considerable perinatal mortality reductions. TRIAL REGISTRATION: Pan African Clinical Trial Registry ( www.pactr.org ): PACTR202006793783148. Registered on 17th June 2020.