Preeclampsia Biomarker Test in African Women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates angiogenic biomarkers for predicting progression to severe preeclampsia in African pregnant women. It uses two parts: first to establish threshold levels on a Roche Elecsys platform with derivation and validation cohorts, then to compare rapid point-of-care tests against these thresholds in the same participants. The research seeks population-specific cutoffs due to differences in baseline profiles and comorbidities. Stored samples may be used for additional platforms as they become available. The study is led by the Africa Clinical Research Network with a site in Harare, Zimbabwe.

Why it matters

Who can join: the full rules

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

Where it's running

• Mutala Trust
  Harare, Harare, Zimbabwe Recruiting

Study contacts

• Study coordinator: Tariro Makadzange
• Email: tariro.makadzange@acrnhealth.com
• Phone: +18572008374

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry for women with preeclampsia and related conditions

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.