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. 2025 Mar 24;22(1):44.
doi: 10.1186/s12978-025-01980-9.

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

Nicole Minckas  1 , Alim Swarray-Deen  2 , Sue Fawcus  3 , Rosa Chemwey Ndiema  4   5 , Annie McDougall  6 , Jennifer Scott  7   8 , Samuel Antwi Oppong  2 , Ayesha Osman  3 , Alfred Onyango Osoti  4 , Katherine Eddy  9   6 , Mushi Matjila  3 , George Nyakundi Gwako  4 , Joshua P Vogel  6 , A Metin A Gülmezoglu  7 , Adanna Uloaku Nwameme  10 , Meghan A Bohren  11 ; PEARLS Trial collaborative group
Collaborators, Affiliations

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

Nicole Minckas et al. Reprod Health. .

Abstract

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).

Keywords: Antenatal care; Artificial Intelligence Ultrasound; Aspirin prophylaxis; Gestational age estimation; Hypertensive disorders of pregnancy; LMICs; Maternal health; Mixed-methods; Pre-eclampsia; Protocol; Risk screening.

Plain language summary

Pre-eclampsia is a condition in pregnancy that causes high blood pressure and can affect the liver, kidneys, and other organs. It is a major cause of death for women and newborns, especially in low- and middle-income countries. Screening pregnant women early helps identify those at risk so they can start preventative treatments, like low-dose aspirin and calcium.This is a research protocol for the first phase of our study (called “PEARLS”) which means that it describes what we plan to do and how we plan to do it. PEARLS explores ways to improve pre-eclampsia prevention. PEARLS will: (1) screen pregnant women to identify who is at a high risk for pre-eclampsia, (2) use an artificial intelligence (AI) ultrasound to estimate how many weeks pregnant the woman is, and, (3) compare two doses of daily aspirin (150 mg vs. 75 mg) to see which dose is more effective and safe for preventing pre-eclampsia.This first phase will take place in Ghana, Kenya, and South Africa. We will interview health workers, policy experts, and pregnant women, and conduct surveys with health workers to understand the challenges of using AI ultrasound, risk screening tools and aspirin for pre-eclampsia prevention. The findings from this phase will help ensure the PEARLS study is successfully carried out in these countries and, ultimately, help reduce pre-eclampsia and improve the health of women and their babies.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study has received or sought ethics approval from the following entities: Australia: University of Melbourne, Office of Research Ethics and Integrity (Reference Number: 2024-28461-49989-3) and the Alfred Hospital Ethics Committee (Reference: Project 727/23); Ghana: Ghana Health Service Ethics Review Committee (GHS-ERC Number 002/01/24); Kenya: Kenyatta National Hospital, University of Nairobi ERC (Ref: KNH-ERC/01/MISC/20); South Africa: University of Cape Town, Faculty of Health Science, Human Research Ethics Committee (HREC Ref: 138/2024). Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Overview of the PEARLS research activities. The mixed-method components of the project are outlined in this protocol
Fig. 2
Fig. 2
Overview of trial processes and key potential challenges to be explored in the formative phase
See this image and copyright information in PMC

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