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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Low-dose low-molecular-weight heparin
DrugLow-molecular-weight heparin given for 7-10 days after delivery: * enoxaparin 4000-6000IU o.d. * nadroparin 3800-5700IU o.d. * dalteparin 5000-7500IU o.d. * tinzaparin 4500-7000IU o.d.
Treatment groups
9,200 Participants
are divided into 2 treatment groupsGroup A: Low-molecular-weight heparinExperimental treatment 1 intervention
Group B: No treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Venous thrombotic outcomes
Centrally-adjudicated, objectively-diagnosed, symptomatic venous thromboembolism (deep vein thrombosis / pulmonary embolism)
Time frame
Within 90 days post-randomizationSecondary outcomes
1
All-cause mortality
Time frame
Within 90 days post-randomization2
Bleeding
Obstetrical and non-obstetrical major and clinically-relevant non-major bleeding
Time frame
Within 90 days post-randomization3
Heparin-induced thrombocytopenia
Time frame
Within 90 days post-randomization4
Surgical site / perineal complications, and endometritis
Time frame
Within 90 days post-randomizationOther outcomes
1
Main safety composite outcome
Composite outcome of centrally-adjudicated obstetrical major bleeding, non-obstetrical major bleeding and/or major surgical site / perineal wound complication
Time frame
Within 90 days post-randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Marc Blondon
Lead sponsor
University Hospital, Geneva
Sponsor institution
Source ClinicalTrials.gov