New Antenatal Model in Africa and India (NAMAI) study: implementation research to improve antenatal care using WHO recommendations
Authors:   NAMAI Research Group, Kouanda Seni , Ouedraogo Adja M. , Sogo Armel E. , Bagaya Ouahabou , Sorgho Tilado E. V. , Hien Yelmali C. , Gbenou Dina V. , Sawadogo Windsouri S. Ramatou , Zoungrana Wilfried , Dadjoari Moussa , Zombré Sanou Valerie M. , Usmanova Gulnoza , Jain Yashpal , Chahar Ram , Kumar Somesh , Kumar S. V. Vinod , Srivastava Ashish , Nair Tapas Sadasivan , Sarkar Abu H. , Bajpai Nitin , Patwardhan Vaibhav , Joshi Chandra Shekhar , Chotiya Manish , Baswal Dinesh , Musange Sabine , Sayinzoga Felix , Mutabazi Vincent , Murindahabi Nathalie K. , Nzeyimana David , Rwabufigiri Bernard Ngabo , Kabuteni Theopista J. , Mugabo Maria , Mbizvo Michael , Chizuni Caren , Chelwa Nachela , Muliokela Rosemary , Phiri Chifundo , Kasonda Kondwani , Okpara Natasha , Nyirenda Muyereka , Malumo Sarai B. , Mwiche Angel , Simushi Virginia , Nsubuga Bakyaita Nathan , Barreix María , Tunçalp Özge , Thwin Soe Soe , Bucagu Maurice , Tamrat Tigest , Habib Ndema , Lefevre Amnesty E. , Lorencatto Fabiana 
Published: August 2023

Abstract
Background
In 2020, an estimated 287 000 women died globally from pregnancy‐related causes and 2 million babies were stillborn. Many of these outcomes can be prevented by quality healthcare during pregnancy and childbirth. Within the continuum of maternal health, antenatal care (ANC) is a key moment in terms of contact with the health system, yet it remains an underutilized platform. This paper describes the protocol for a study conducted in collaboration with Ministries of Health and country research partners that aims to employ implementation science to systematically introduce and test the applicability of the adapted WHO ANC package in selected sites across four countries.

Methods
Study design is a mixed methods stepped-wedge cluster randomized implementation trial with a nested cohort component (in India and Burkina Faso). The intervention is composed of two layers: (i) the country- (or state)-specific ANC package, including evidence-based interventions to improve maternal and newborn health outcomes, and (ii) the co-interventions (or implementation strategies) to help delivery and uptake of the adapted ANC package. Using COM-B model, co-interventions support behaviour change among health workers and pregnant women by (1) training health workers on the adapted ANC package and ultrasound (except in India), (2) providing supplies, (3) conducting mentoring and supervision and (4) implementing community mobilization strategies. In Rwanda and Zambia, a fifth strategy includes a digital health intervention. Qualitative data will be gathered from health workers, women and their families, to gauge acceptability of the adapted ANC package and its components, as well as experience of care. The implementation of the adapted ANC package of interventions, and their related costs, will be documented to understand to what extent the co-interventions were performed as intended, allowing for iteration.

Discussion
Results from this study aim to build the global evidence base on how to implement quality ANC across different settings and inform pathways to scale, which will ultimately lead to stronger health systems with better maternal and perinatal outcomes. On the basis of the study results, governments will be able to adopt and plan for national scale-up, aiming to improve ANC nationally. This evidence will inform global guidance.
Trial registration number: ISRCTN, ISRCTN16610902. Registered 27 May 2022. https://www.isrctn.com/ISRCTN16610902