PROgnostic testing to enhance clinical triage of preeclampsia in africa (PROTECT-Africa): biomarker validation for timely intervention in hypertensive disorders of pregnancy

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.