Actively Recruiting
Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis: A Pragmatic, Multi-center, Open-label Randomized Controlled Study
Led by Marc Blondon · Updated on 2026-02-17
9200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the use of short-term low-dose low-molecular-weight heparin (LMWH) in women after delivery to see if it changes the risk of blood clots called venous thromboembolism (VTE) within 90 days postpartum. The study also looks at whether this treatment affects risks such as bleeding and wound problems. It is a phase 3 clinical trial comparing LMWH treatment to no treatment in postpartum women with certain risk factors. Participants assigned to the treatment group will take low-dose LMWH for 7 to 10 days after delivery. The LMWH doses include enoxaparin, nadroparin, dalteparin, or tinzaparin at specified low doses once daily. The other group will receive no treatment. This is an open-label study with randomized allocation, meaning participants are randomly assigned to either the treatment or no treatment group without blinding. Women in the study will be followed and monitored for 90 days after delivery. Researchers will track outcomes including blood clot events, bleeding, wound complications, infections, maternal quality of life, and hospital stay length. Imaging will be used to check for blood clots, and safety events will be recorded. The goal is to understand the benefits and risks of short-term LMWH use after childbirth in women with postpartum risk factors.
CONDITIONS
Brief Title
Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women after delivery
- At least 1 major risk factor or 2 minor risk factors for postpartum blood clots
- Major risk factors include emergency cesarean section, pre-pregnancy BMI ≥35 kg/m2, known low-risk thrombophilia, pre-eclampsia, pre-term delivery, peripartum systemic infection, intra-uterine growth restriction, and pregnancy loss
- Minor risk factors include age 35 years or older, pre-pregnancy BMI 30.0-34.9 kg/m2, current smoking, elective cesarean section, postpartum hemorrhage, and antenatal immobility
- Female gender
- Age 18 years or older
You will not qualify if you...
- Receiving two or more doses of postpartum low-molecular-weight heparin
- Any indication for therapeutic anticoagulation
- High risk of postpartum venous thromboembolism
- Increased risk of bleeding
- Contraindication to heparin
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 to 10 days
Participants receive low-dose low-molecular-weight heparin for 7 to 10 days after delivery to prevent postpartum thrombosis.
1 baseline visit and up to 10 daily visits for medication administration
Duration - Up to 90 days after randomization
Participants are monitored for safety and outcomes such as venous thrombotic events, bleeding, and other complications for up to 90 days after randomization.
Follow-up visits as scheduled within 90 days post-randomization
Trial Site Locations
Total: 1 location
1
Geneva University Hospitals
Geneva, Switzerland
Actively Recruiting
Research Team
M
Marc Blondon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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