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Background <p>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&#xa0;daily aspirin doses (75&#xa0;mg v 150&#xa0;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&#xa0;feasibility of implementing these activities in participating facilities in Ghana, Kenya, and South Africa.</p> Methods <p>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 participate in the trial activities. Data will be analyzed using thematic analysis and triangulated across sources and participant groups. The findings will inform trial design and help optimize implementation.</p> Discussion <p>The research will provide critical insights into the feasibility of pre-eclampsia risk screening and AI ultrasound for gestational age estimation in resource-limited settings. By identifying factors that can influence implementation of pre-eclampsia prevention and care pathways, the findings will inform successful execution of the PEARLS trial, and post-research scale-up activities. This, in turn, can help reduce the prevalence of pre-eclampsia, and improve maternal and newborn outcomes in high-burden settings.</p> <p><i>Trial registration</i>: PACTR202403785563823 || pactr.samrc.ac.za (Date of registration: 12 March 2024).</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月24日

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  • Nicole Minckas,
  • Alim Swarray-Deen,
  • Sue Fawcus,
  • Rosa Chemwey Ndiema,
  • Annie McDougall,
  • Jennifer Scott,
  • Samuel Antwi Oppong,
  • Ayesha Osman,
  • Alfred Onyango Osoti,
  • Katherine Eddy,
  • Mushi Matjila,
  • George Nyakundi Gwako,
  • Joshua P. Vogel,
  • A. Metin A. Gülmezoglu,
  • Adanna Uloaku Nwameme,
  • Meghan A. Bohren,
  • 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 Nguyen,
  • Jenipher Echenje Okore,
  • Zahida P. Qureshi,
  • Josephine Rabele,
  • Julie A. Simpson,
  • Inge Smit,
  • Ama Asantewaa Tamatey,
  • Alessandra Tomazzini

摘要

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 participate in the trial activities. Data will be analyzed using thematic analysis and triangulated across sources and participant groups. The findings will inform trial design and help optimize implementation.

Discussion

The research will provide critical insights into the feasibility of pre-eclampsia risk screening and AI ultrasound for gestational age estimation in resource-limited settings. By identifying factors that can influence implementation of pre-eclampsia prevention and care pathways, the findings will inform successful execution of the PEARLS trial, and post-research scale-up activities. This, in turn, can help reduce the prevalence of pre-eclampsia, and improve maternal and newborn outcomes in high-burden settings.

Trial registration: PACTR202403785563823 || pactr.samrc.ac.za (Date of registration: 12 March 2024).