Evidence map›Paper›PMID 40128812›Full record

ArticleReproductive health2025

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

Nicole Minckas, Alim Swarray-Deen, Sue Fawcus, Rosa Chemwey Ndiema, Annie McDougall, Jennifer Scott, Samuel Antwi Oppong, Ayesha Osman, Alfred Onyango Osoti, Katherine Eddy and 7 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Reproductive health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
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  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Nicole MinckasNossal Institute for Global Health, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. nicole.minckas@unimelb.edu.au.
Alim Swarray-DeenDepartment of Obstetrics and Gynaecology, University of Ghana Medical School, College of Health Sciences, Accra, Ghana.
Sue FawcusDepartment of Obstetrics and Gynaecology, University of Cape Town, Cape Town, South Africa.
Rosa Chemwey NdiemaDepartment of Obstetrics and Gynaecology, Faculty of Health Sciences, University of Nairobi, Nairobi, Kenya.
Annie McDougallWomen's, Children's and Adolescents' Health Program, Burnet Institute, Melbourne, Australia.
Jennifer ScottConcept Foundation, Geneva, Switzerland.
Samuel Antwi OppongDepartment of Obstetrics and Gynaecology, University of Ghana Medical School, College of Health Sciences, Accra, Ghana.
Ayesha OsmanDepartment of Obstetrics and Gynaecology, University of Cape Town, Cape Town, South Africa.
Alfred Onyango OsotiDepartment of Obstetrics and Gynaecology, Faculty of Health Sciences, University of Nairobi, Nairobi, Kenya.
Katherine EddyNossal Institute for Global Health, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.
Mushi MatjilaDepartment of Obstetrics and Gynaecology, University of Cape Town, Cape Town, South Africa.
George Nyakundi GwakoDepartment of Obstetrics and Gynaecology, Faculty of Health Sciences, University of Nairobi, Nairobi, Kenya.
Joshua P VogelWomen's, Children's and Adolescents' Health Program, Burnet Institute, Melbourne, Australia.
A Metin A GülmezogluConcept Foundation, Geneva, Switzerland.
Adanna Uloaku NwamemeDepartment of Social and Behavioural Sciences, School of Public Health, University of Ghana, College of Health Sciences, Accra, Ghana.
Meghan A BohrenNossal Institute for Global Health, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. Meghan.bohren@unimelb.edu.au.
PEARLS Trial collaborative group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPre-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.

methodsWe 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 registrationPACTR202403785563823 || pactr.samrc.ac.za (Date of registration: 12 March 2024).

Indexed as

AspirinMass ScreeningPre-EclampsiaArtificial IntelligenceCross-Sectional StudiesFemaleGestational AgeHumansPregnancyPrenatal CareRisk AssessmentUltrasonography, PrenatalAspirinAntenatal careArtificial Intelligence UltrasoundAspirin prophylaxisGestational age estimationHypertensive disorders of pregnancyLMICsMaternal healthMixed-methodsPre-eclampsiaProtocolRisk screening

Identifiers

PMID40128812
PMCPMC11934789

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.