Comparing Low Molecular Weight Heparin Plus Aspirin to Aspirin Alone for Preventing Preeclampsia in High-Risk Pregnant Women

What this Trial Is About

Preeclampsia is a serious condition affecting pregnant women and their babies worldwide. Researchers are studying whether adding low molecular weight heparin LMWH to low-dose aspirin can better prevent preeclampsia in women at high risk compared to aspirin alone. This randomized controlled trial focuses on pregnant women with a high risk of developing preeclampsia, aiming to provide clearer evidence on the benefits of combined treatment. Participants will be randomly assigned to one of two groups one receiving 160 mg of aspirin daily before bedtime, and the other receiving the same aspirin dose plus a daily weight-adjusted dose of tinzaparin LMWH injected in the morning. Treatments start before 16 weeks of pregnancy and continue until 36 weeks gestation. Risk assessment uses a recognized model combining ultrasound, blood tests, and medical history. Throughout the study, women will have blood samples taken at 20-24, 32-34, and 36 weeks to measure various biomarkers related to inflammation and placental health. Regular phone calls will track medication adherence and any side effects. The main outcome measured is the occurrence of preeclampsia up to delivery, with additional outcomes including early preeclampsia, gestational hypertension, preterm birth, and newborn health until hospital discharge. The total participation lasts from enrollment until delivery, with ongoing monitoring.

LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention