This clinical trial is focused on studying the effects of a treatment for a condition known as preterm premature rupture of membranes (PPROM), which occurs when the water breaks too early in pregnancy, specifically before 34 weeks of gestation. The treatment being tested is a medication called nifedipine, which is taken as a prolonged-release tablet. The study also involves a comparison with a placebo, which is a substance with no active medication.
The purpose of the study is to determine if using nifedipine for a short period of 48 hours can help reduce the risks to the baby and mother when PPROM occurs between 22 and 33 weeks of pregnancy. Participants in the study will be randomly assigned to receive either the medication or the placebo, and neither the participants nor the researchers will know which one is being given, to ensure unbiased results.
The study will monitor several outcomes, including the health of the baby at birth and up to discharge from the hospital, as well as the health of the mother. It will also look at how long the pregnancy can be safely prolonged and the health of the baby at two years of age. The study aims to provide valuable information on managing PPROM to improve outcomes for both mothers and their babies.
France