Formative research to optimize pre-eclampsia risk-screening and prevention (PEARLS): study protocol

作者：Nicole Minckas, Alim Swarray‐Deen, Sue Fawcus, Rosa C Ndiema, Annie R. A. McDougall, Jennifer Scott, Samuel A. Oppong, Ayesha Osman, Alfred Osoti, Katherine E. Eddy, Mushi Matjila, George Gwako, Joshua P. Vogel, A Metin Gülmezoglu, Adanna Nwameme, Meghan A. Bohren, the PEARLS Trial collaborative group, Amanda Adu-Amankwah, Kwame Adu-Bonsaffoh Kwame, Edna Arends, Kara Blackburn, Lester Chinery, Nathaniel Coleman, Rachel Craik, Alessandra Fleurent, Mark Laws, Robert K. Mahar, Teresiah Njambi Maina, Tetteh Edmund Nartey, Long Hoang Nguyen, Jenipher Okore, Zahida Qureshi, Josephine Rabele, Julie A. Simpson, Inge Smit, Ama Tamatey, Alessandra Tomazzini · 发表于：Reproductive Health · 年份：2025 · DOI：10.1186/s12978-025-01980-9 · 被引用次数：10 · 研究领域：Pregnancy and preeclampsia studies、Maternal and fetal healthcare、Global Maternal and Child Health

BACKGROUND: Pre-eclampsia is a leading cause of maternal and neonatal mortality, affecting nearly 5% of pregnant women worldwide. Accurate and timely risk-screening of pregnant women is essential to start preventive therapies as early as possible, including low-dose aspirin and calcium supplementation. In the formative phase for the "Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening" (PEARLS) trial, we aim to validate and implement a pre-eclampsia risk-screening algorithm, and validate an artificial intelligence (AI) ultrasound for gestational age estimation. In the trial phase, we will compare different daily aspirin doses (75 mg v 150 mg) for pre-eclampsia prevention and postpartum bleeding. This study protocol outlines the mixed-methods formative phase of PEARLS, which will identify challenges and the feasibility of implementing these activities in participating facilities in Ghana, Kenya, and South Africa. METHODS: We will employ qualitative and quantitative methods to identify factors that may influence trial implementation. In-depth interviews and focus group discussions with policy stakeholders, research midwives, health workers, and pregnant women will explore the barriers, facilitators, and acceptability of pre-eclampsia risk screening, AI ultrasound, and aspirin uptake. A cross-sectional survey of antenatal care and maternity health workers will assess current clinical practices around pre-eclampsia and willingness to participat...