PROTECT-Africa: Biomarker Validation for Preeclampsia Triage
Recruiting · NCT07810439 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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 result levels that best predict whether a woman will or will not develop severe preeclampsia in the following weeks, using a well-established laboratory test as the standard for comparison. Second, they will check how closely the rapid clinic tests match that laboratory standard. The study will also look at what these tests cost and whether using them could save money for families and health services. The study will include about 1,106 pregnant women at large maternity hospitals in Zimbabwe, Rwanda and Tanzania. Women may join if they are between 23 and 37 weeks pregnant with one baby and their care team suspects preeclampsia, for example because of raised blood pressure, protein in the urine, or symptoms such as headache, swelling or vision changes. Taking part does not change a woman's medical care in any way. Women will attend their usual pregnancy visits, plus study visits at 1 week, 2 weeks and 4 weeks, at delivery, and about 4 weeks after birth. At these visits the study team will record health information and collect blood and urine samples. About 15 ml of blood (around one tablespoon) is collected at each visit. The test results are not used to make any decisions about a woman's treatment. Doctors and nurses caring for her will not see them, and neither will she. All treatment decisions stay with her own healthcare team. Routine tests such as blood counts and liver tests are shared with her care team as usual. The results of this study may help clinics in Africa spot dangerous preeclampsia earlier, so mothers and babies can be treated in time.
Who can take part
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 is running
1 location listed.
- Mutala Trust - Harare, Harare, Zimbabwe