This randomized controlled trial compares the combination of low-dose aspirin plus low molecular weight heparin (LMWH) versus aspirin alone for the prevention of preeclampsia in gravidas at high risk. The premise is that aspirin begun in the first trimester reduces preeclampsia risk in high-risk individuals, whereas LMWH may confer additional benefit through anticoagulant, anti-inflammatory, and endothelial protective mechanisms. Evidence to date regarding the incremental value of adding LMWH to aspirin remains limited and inconsistent, hence the current study seeks to clarify whether combined therapy lowers the incidence of preeclampsia compared with aspirin monotherapy. Key design and status notes: the trial is interventional with a primary prevention aim, enrolling high-risk pregnant individuals. It estimates enrolling 100 participants and is currently in the recruiting phase with completion anticipated in July 2027. The study is categorized under critical care concerns related to hypertensive disorders of pregnancy, including preeclampsia and gestational hypertension, and involves agents including tinzaparin as the LMWH component.
Official title: Combined Administration of Low Molecular Weight Heparin and Aspirin Versus Aspirin Alone in Gravidas at High Risk for Preeclampsia: A Randomized Controlled Trial
Summary: Preeclampsia is a major cause of maternal and perinatal morbidity and mortality worldwide. Low-dose aspirin started in the first trimester reduces the risk of preeclampsia in high-risk women. Low molecular weight heparin (LMWH) has shown potential benefits in addition to aspirin for preventing preeclampsia through its anticoagulant, anti-inflammatory, and endothelial protective effects. However, current evidence is limited and conflicting regarding the added value of LMWH to aspirin. This randomized controlled trial aims to evaluate the efficacy of combined aspirin and LMWH, compared to aspirin alone, for reducing the incidence of preeclampsia in high-risk gravidas.
Conditions: Preeclampsia Severe, Toxemia Of Pregnancy, Preeclampsia, Pregnancy Complications, Hypertension, Pregnancy-Induced, Gestational Hypertension
Keywords: preeclampsia, gestational hypertension, toxemia, Preeclampsia prevention, Low molecular weight heparin, tinzaparin, High-risk pregnancy, LMWH, Maternal-fetal medicine
Study type: INTERVENTIONAL
Primary purpose: PREVENTION
Phases: PHASE4
Enrollment: 100 (ESTIMATED)
Status: RECRUITING
Completion: 2027-07-01 (ESTIMATED)