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

NCT07140211 | Recruiting Phase 3 DMC

• 1 other identifier: 2025-00622
• Study Type: interventional
• Target: 9,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Thromboembolism (VTE); Postpartum

Outcome Measures

Primary Outcomes (1)

• Venous thrombotic outcomes

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

  Within 90 days post-randomization

Secondary Outcomes (13)

• All-cause mortality

  Within 90 days post-randomization

• Bleeding

  Within 90 days post-randomization

• Heparin-induced thrombocytopenia

  Within 90 days post-randomization

• Surgical site / perineal complications, and endometritis

  Within 90 days post-randomization

• Septic pelvic thrombosis

  Within 90 days post-randomization

Other Outcomes (1)

• Main safety composite outcome

  Within 90 days post-randomization

Study Arms (2)

Low-molecular-weight heparin

EXPERIMENTAL

Drug: Low-dose low-molecular-weight heparin

No treatment

NO INTERVENTION

Interventions

Low-dose low-molecular-weight heparin DRUG

Low-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.

Low-molecular-weight heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• ≥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

Sponsors & Collaborators

• Marc Blondon: lead

Study Sites (1)

Geneva University Hospitals

Geneva, Switzerland

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Marc Blondon

CONTACT

(+41).22.372.92.92; marc.blondon@hug.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CH (1)