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PROTECT-Africa: Biomarker Validation for Preeclampsia Triage

Recruitingn/aAges 18 Years - 50 YearsFemaleAfrica Clinical Research Network (ACRN)
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In plain words

What the trial is, and whether it could suit you

Preeclampsia is a serious high blood pressure condition that can develop during pregnancy. It is one of the leading causes of death and illness for mothers and babies in Africa. Doctors find it hard to tell which women with high blood pressure in pregnancy will go on to become seriously ill, because the tests available today are not accurate enough and are often not available in local clinics. Two proteins in the blood, called sFlt-1 and PlGF, may help predict who is at risk. The balance between them (the sFlt-1/PlGF ratio) has been useful in other parts of the world, but it has not been properly tested in African women. New rapid tests can measure these proteins at the clinic in minutes, using a small blood or urine sample, without a large laboratory. This study will look at how well these tests work in African women. Researchers will do two things. First, they will work out the resul

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ130 mmHg or diastolic โ‰ฅ80 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 โ‰ฅ140 mmHg and/or diastolic โ‰ฅ90 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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What it tests

  • Not listed
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Where

1 site
Mutala Trust
Harare, Zimbabwe
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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