Who is the study aimed at? Any woman over the age of 18 who is pregnant for the first time, who is between week 35 and 37 of pregnancy and who has not had any previous complications can participate in the study. An estimated 5500 to 6000 women will participate in the study.
What is it? Participation consists only of a blood test taken between weeks 35 and 37 of pregnancy. The test will measure the levels of sFlt1 and PlGF, factors found in the blood that are called markers of placental function.
It is known that the ratio between these markers (sFlt1/PlGF) can identify mothers who will develop early hypertensive complications in pregnancy from those who will not with very high reliability. The PE37 study will examine whether the ratio between sFlt1 and PlGF can also identify mothers who will develop preeclampsia at the end of their pregnancy.
How will we do that? PE37 is a prospective, open-label randomized study with parallel groups. This means that to find out whether measuring the sFlt1 and PlGF markers using a blood test is better than not doing so, we will compare the results between two groups (the control and study groups). The moment the mother consents to participate in the study, she will be assigned to one of the two random groups:
- Control group: An analysis will be carried out between weeks 35 and 37 of pregnancy, but neither the mother nor the medical team will know the result of the analysis and the hospital’s usual protocol for monitoring the pregnancy will continue.
- Study group: An analysis will be performed between weeks 35 and 37 of pregnancy. The doctor will know the result and will guide the mother on the most appropriate way to continue her pregnancy based on this, the weeks of gestation and on clinical data as well as the usual tests for preeclampsia. If the result is normal, the pregnancy will continue with the mother’s usual midwife or doctor. In case of any abnormalities, the mothers of the study group will be contacted to have a consultation with a specialist in maternal-fetal medicine and may be offered an induction from the 37th week of pregnancy onwards, when it is known to be safe and before complications associated with late onset preeclampsia can occur.
All the mothers in the study, regardless of the group they are in, will receive all the medical care established by current protocols. In addition, there will be a later follow up, to assess the status of mothers and babies.