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

Locations (8)

Kantonsspital Baden

Baden, Switzerland

RECRUITING

Universitätsspital Basel

Basel, Switzerland

RECRUITING

Lindenhofspital

Bern, Switzerland

RECRUITING

Geneva University Hospitals

Geneva, Switzerland

RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

RECRUITING

Ente Ospedaliero Cantonale

Lugano, Switzerland

RECRUITING

Réseau Hospitalier Neuchâtelois

Neuchâtel, Switzerland

RECRUITING

Hôpital du Valais

Sion, Switzerland

RECRUITING

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 (8)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts