Two proteins could give african clinics an early warning for dangerous pregnancy complication

NCT ID NCT07810439

Diagnosis Sponsor: Africa Clinical Research Network (ACRN) Source: ClinicalTrials.gov ↗

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Preeclampsia is a serious high blood pressure condition that can develop during pregnancy and is a leading cause of death for mothers and babies in Africa. Doctors struggle to predict which women with high blood pressure will become severely ill because current tests are not accurate enough or unavailable in local clinics. This study will check whether measuring two proteins in the blood, sFlt-1 and PlGF, can help predict severe preeclampsia in about 1,106 pregnant women in Zimbabwe, Rwanda and Tanzania. Researchers will also see how well rapid clinic tests match standard laboratory results and what the tests cost. The study does not change anyone's medical care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: sFlt-1/PlGF ratio blood test
What this could lead to: If the tests work well, clinics in Africa could spot dangerous preeclampsia earlier and treat mothers before complications become severe.
What could go wrong: The study only checks how well the tests predict risk, not whether using them improves outcomes. The cut-off values may not work the same way in every clinic or population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,106 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant women presenting with hypertensive disorders of pregnancy at high-volume maternity referral centres in Zimbabwe, Rwanda and Tanzania. Participants are enrolled between 23 weeks 0 days and 36 weeks 6 days of gestation and span a spectrum of severity, including gestational hypertension, chronic hypertension, suspected preeclampsia and superimposed preeclampsia. Participants who do not develop preeclampsia, eclampsia, HELLP syndrome or intrauterine growth restriction through four weeks postpartum serve as the comparator group for evaluating point-of-care test performance. Recruitment is consecutive from routine antenatal and maternity care.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Gestational age between 23 weeks 0 days and 36 weeks 6 days, established by ultrasound performed at 22 weeks of gestation or earlier Singleton pregnancy Suspicion of a clinical diagnosis of preeclampsia based on one or more of the following: new onset of elevated blood pressure (systolic ≥130 mmHg or diastolic ≥80 mmHg); aggravation of pre-existing hypertension; new onset of protein in urine; aggravation of pre-existing proteinuria; or one or more other reasons for clinical suspicion of preeclampsia Other reasons for clinical suspicion include preeclampsia-related symptoms (epigastric pain, excessive oedema or severe swelling of the face, hands or feet, headache, visual disturbances, or sudden weight gain greater than 1 kg per week in the third trimester) or preeclampsia-related findings (low platelets, elevated liver transaminases, suspected intrauterine growth restriction, or abnormal uterine perfusion on Doppler sonography with mean pulsatility index above the 95th percentile in the second trimester and/or bilateral uterine artery notching, where available) Not currently enrolled in any other study or receiving an investigational medicinal product Able to provide informed consent Exclusion Criteria: * Multiple pregnancy (for example twins or triplets) Proteinuria 2+ or greater on dipstick AND elevated blood pressure (systolic ≥140 mmHg and/or diastolic ≥90 mmHg, reproducible on two occasions) Proteinuria 2+ or greater on dipstick and current antihypertensive treatment Confirmed diagnosis of HELLP syndrome No verified or documented ultrasound scan performed prior to 22 weeks of gestation to establish gestational age

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Conditions

The condition(s) this trial relates to.

eclampsia fetal growth restriction HELLP syndrome hypertension, pregnancy-induced preeclampsia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eclampsia Fetal growth retardation Hellp syndrome Hypertension, pregnancy induced Pre-eclampsia

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Two proteins could give african clinics an early warning for dangerous pregnancy complication

What the study statuses mean