Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis

Phase 3RecruitingNCT07140211

Marc Blondon9,200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

9,200

Conditions

Venous Thromboembolism (VTE)Postpartum

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: postpartum women after delivery AND ≥1 major risk factor / ≥2 minor risk factors: * 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 Exclusion Criteria: * ≥2 doses of postpartum LMWH * Any indication for therapeutic anticoagulation * A high-risk of postpartum VTE * An increased bleeding risk * A contra-indication to heparin

Outcomes

Primary Outcomes

Venous thrombotic outcomes

Centrally-adjudicated, objectively-diagnosed, symptomatic venous thromboembolism (deep vein thrombosis / pulmonary embolism)

Time frame: Within 90 days post-randomization

Secondary Outcomes

All-cause mortality

Time frame: Within 90 days post-randomization

Bleeding

Obstetrical and non-obstetrical major and clinically-relevant non-major bleeding

Time frame: Within 90 days post-randomization

Heparin-induced thrombocytopenia

Time frame: Within 90 days post-randomization

Surgical site / perineal complications, and endometritis

Time frame: Within 90 days post-randomization

Septic pelvic thrombosis

Time frame: Within 90 days post-randomization

Superficial vein thrombosis

Time frame: Within 90 days post-randomization

Stroke and cerebral vein thrombosis

Time frame: Within 90 days post-randomization

Persistent lochia

Time frame: At 42 day post-randomization

Maternal quality of life

Measured by the PROMIS global short form (PROMIS-10) questionnaire

Time frame: At 14 days post-randomization

Maternity clot risk

Time frame: Within 90 days post-randomization

VTE surveillance (imaging)

Time frame: Within 90 days post-randomization

Duration of hospital stay

Time frame: Within 90 days post-randomization

Serious adverse events

Time frame: Within 90 days post-randomization

Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts