Minckas Nicole, Swarray-Deen Alim, Fawcus Sue, Ndiema Rosa Chemwey, McDougall Annie, Scott Jennifer, Oppong Samuel Antwi, Osman Ayesha, Osoti Alfred Onyango, Eddy Katherine, Matjila Mushi, Gwako George Nyakundi, Vogel Joshua P, Gülmezoglu A Metin A, Nwameme Adanna Uloaku, Bohren Meghan A
Nossal Institute for Global Health, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.
Department of Obstetrics and Gynaecology, University of Ghana Medical School, College of Health Sciences, Accra, Ghana.
Reprod Health. 2025 Mar 24;22(1):44. doi: 10.1186/s12978-025-01980-9.
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.
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.
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.
PACTR202403785563823 || pactr.samrc.ac.za (Date of registration: 12 March 2024).
子痫前期是孕产妇和新生儿死亡的主要原因，影响着全球近5%的孕妇。对孕妇进行准确及时的风险筛查对于尽早开始预防性治疗至关重要，这些治疗包括低剂量阿司匹林和补钙。在“预防子痫前期：风险筛查后评估低剂量阿司匹林方案”（PEARLS）试验的形成阶段，我们旨在验证并实施一种子痫前期风险筛查算法，并验证一种用于估计胎龄的人工智能（AI）超声。在试验阶段，我们将比较不同的每日阿司匹林剂量（75毫克与150毫克）对子痫前期预防和产后出血的效果。本研究方案概述了PEARLS的混合方法形成阶段，该阶段将确定在加纳、肯尼亚和南非的参与机构中实施这些活动的挑战和可行性。
我们将采用定性和定量方法来确定可能影响试验实施的因素。与政策利益相关者、研究助产士、卫生工作者和孕妇进行深入访谈和焦点小组讨论，将探讨子痫前期风险筛查、AI超声和阿司匹林使用的障碍、促进因素和可接受性。对产前护理和产科卫生工作者进行横断面调查，将评估当前围绕子痫前期的临床实践以及参与试验活动的意愿。数据将使用主题分析进行分析，并在不同来源和参与者群体之间进行三角验证。研究结果将为试验设计提供信息，并有助于优化实施。
该研究将为在资源有限的环境中进行子痫前期风险筛查和AI超声估计胎龄的可行性提供关键见解。通过确定可能影响子痫前期预防和护理途径实施的因素，研究结果将为PEARLS试验的成功执行以及研究后的扩大规模活动提供信息。这反过来可以帮助降低子痫前期的患病率，并改善高负担环境中的孕产妇和新生儿结局。
PACTR202403785563823 || pactr.samrc.ac.za（注册日期：2024年3月12日）
