Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMarc Blondon
About this trial
The goal of this clinical trial is to evaluate the risk-benefit of a short-term treatment with a low-dose low-molecular-weight heparin (LMWH), in the postpartum period (after delivery). The main questions it aims to answer are:
* compared to no treatment, does short-term postpartum LMWH modify the risk of venous thromboembolism within 90 days of delivery? * compared to no treatment, does short-term postpartum LMWH modify the risks of bleeding and wound complications? Participants will take low-dose LMWH for 7-10 days or no treatment, and will be followed for 90 days post-delivery.
Eligibility criteria
Qualifiers
Major risk factors: Emergency cesarean section ; Pre-pregnancy BMI ≥35kg/m2 ; Known low-risk thrombophilia (heterozygous factor V Leiden; heterozygous G20210 prothrombin mutation) ; Pre-eclampsia ; Pre-term delivery ; Peripartum systemic infection ; Intra-uterine growth restriction ; Pregnancy loss
Minor risk factors: Age ≥35 years ; Pre-pregnancy BMI 30.0-34.9kg/m2 ; Current smoking ; Elective cesarean section ; Postpartum hemorrhage ; Antenatal immobility
Disqualifiers
≥2 doses of postpartum LMWH
Any indication for therapeutic anticoagulation
A high-risk of postpartum VTE
An increased bleeding risk
Trial design
Treatments tested in this trial
- Low-dose low-molecular-weight heparin
Treatment groups
9,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Marc Blondon
Lead sponsor
University Hospital, Geneva
Sponsor institution
Source ClinicalTrials.gov