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ClinicalTrials.gov ID

NCT06845423

Lead Sponsor

University Hospital, BrestOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

2,400Estimated

Last Update Posted

Jun 10, 2026Actual

Start Date

May 16, 2025Actual

Primary Completion Date

May 16, 2028Estimated

Completion Date

Aug 16, 2028Estimated

Official Title

Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk. An Open-label, Randomized, Controlled Trial Comparing Two Strategies With or Without Pharmacological Thromboprophylaxis

Brief Summary

Venous thromboembolism (VTE) is currently the second cause of death in women of reproductive age worldwide. The incidence of VTE during pregnancy is 1.2 to 1.4/1000 women, half of VTE occurring during postpartum and as PE in majority of cases, accounting for 8.8% of maternal deaths.

Majority of postpartum VTE occurs in women with one or more moderate risk factors (obesity, caesarean section, postpartum hemorrhage). For these women at intermediate risk, the efficacy and safety of thromboprophylaxis have not been assessed yet during postpartum and international guidelines for pharmacological thromboprophylaxis, based on data extrapolated from other populations, observational studies and small clinical trials are inconsistent across countries.

We designed an open-label, randomized, controlled trial, aiming to demonstrate the superiority of a pharmacological thromboprophylaxis strategy with LMWH (LMWH type chosen according to physician / patient's preference) during 6 weeks after delivery (the 6-weeks follow-up visit being matched with usual care) in women at intermediate risk, over no pharmacological thromboprophylaxis.

• Venous Thromboembolism (VTE)
• Post Partum Women

• Low molecular weight heparin

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Women at intermediate risk of VTE during post-partum= with a 3% or more risk of VTE based on a validated prediction model* or International guidelines (ACCP 2012).

• Age over 18 years

• Delivery between 6 hours and < 36 hours

• Written informed consent

  • Definition: Intermediate risk is defined as ≥ 3%, based on risk prediction model developed by Sultan et al taking in account: smoking, varicose veins, obesity, comorbidities, diabetes, pre-eclampsia, post-partum hemorrhage, postpartum infection, emergency or elective section or following ACCP guidelines: one major risk factor or two minor risk factors.

Exclusion Criteria:

• Previous personal history of VTE
• LMWH started during antenatal period
• Need for anticoagulation at curative dose
• Contraindication to LMWH (previous heparin induced thrombopenia, hemostatic impairment, known severe renal insufficiency)
• Women who received more than two doses of LMWH since delivery
• Unable or refusal to give informed consent
• Aspirin at a daily dose 100 mg or dual antiplatelet therapy
• Previous inclusion in Mum-VTE study
• Concomitant participation in another therapeutic study

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University Hospital, BrestOTHER

caroline.bohec@ch-pau.fr05 59 92 50 04 ext. +33