Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial (PP-HEP)

University Hospitals (UH)

Status and phase

Completed

Phase 3

Conditions

Venous Thromboembolism

Treatments

Drug: Enoxaparin

Study type

Interventional

Funder types

Other

Identifiers

NCT05878899

UGeneva 2021-02350

Details and patient eligibility

About

In previous attemps to answer the question of risk-benefit of postpartum thromboprophylaxis, researchers were faced with low recruitement rates. The goal of this pilot feasibility randomized controlled trial of postpartum pharmacological thromboprophylaxis is to examine the feasibility (recruitement rate) and participation rate at the Geneva University Hospitals

Enrollment

77 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: adult women within 48h of delivery, with:

≥2 of the following risk factors Age ≥35 years Pre-pregnancy BMI 30.0-34.9kg/m2 Current smoking Elective cesarean section Postpartum hemorrhage Antenatal immobility
and/or ≥1 of the following 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 (<37th week of gestation) Peripartum systemic infection (defined as fever with use of antibiotics) Intra-uterine growth restriction (birth weight <5th percentile)

Exclusion Criteria:

any indication for therapeutic anticoagulation
a high-risk of postpartum venous thromboembolism (personal history, high-risk thrombophilia)
an increased bleeding risk
a contra-indication to the use of heparin