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
Authors: Akuze Joseph , Annerstedt Kristi Sidney , Benova Lenka , Chipeta Effie , Dossou Jean-Paul , Gross Mechthild M. , Kidanto Hussein , Marchal Bruno , Alvesson Helle Mölsted , Pembe Andrea B. , van Damme Wim , Waiswa Peter , Hanson Claudia ,   ALERT Study Team, Namazzi Gertrude , Babirye Josephine , Wanduru Philip , Alvesson Helle Mölsted , Orsini Nicola , Unkels Regine , Pleguezuelo Virginia Castellano , Snijders Rian , Delvaux Therese , Kandeya Bianca , Mussa Razak , Meja Samuel , Stones William , Nyirenda Yesaya Z. , Laure Ahossi Angèle Florence , Sognonvi Antoinette , Vigan Armelle , Hamed Banougnin Bolade , Bello Kéfilath , Metogni Christelle Boyi , Houngbo Gisele , Agballa Gottfried , Hounkpati Hashim , Agbla Schadrac , Welsh Joanne , Abeid Muzdalifat , Mwansisya Tumbwene , Alwy Al-Beity Fadhlun M. , Julius Zamoyoni , Mkoka Dickson , Mselle Lilian T. , Mwilike Beatrice , Naburi Helga , Ayebare Elizabeth O. , Pembe Andrea B. , Moller Ann-Beth Nygaard , Marchal Bruno , Hanson Claudia , Chipeta Effie , Ayebare Elizabeth Ombeva , Hounkpatin Hashim , Gandaho Pacos , Kidanto Hussein L. , Dossou Jean-Paul , Akuze Joseph , Annerstedt Kristi Sidney , Benova Lenka , Mselle Lilian , Gross Mechthild , Waiswa Peter , Van Damme Wim , Hall Jennifer , Lampa Erik , Qureshi Zahida 
Published: December 2021

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.