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Recruiting NCT07140211

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

Phase III Interventional Venous Thromboembolism (VTE) Postpartum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-dose low-molecular-weight heparin.
Who it may be relevant to
Registry conditions: Venous Thromboembolism (VTE), Postpartum. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Short-term Low-dose Low-molecular-weight Heparin to Prevent Postpartum Thrombosis: a Pragmatic, Multi-center, Open-label Randomized Controlled Study

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.

Interventions

  • Drug Low-dose low-molecular-weight heparin
    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.

Primary outcome measures

  • Venous thrombotic outcomes [Time frame: Within 90 days post-randomization]
Secondary outcome measures (12)
  • All-cause mortality [Time frame: Within 90 days post-randomization]
  • 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 [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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Switzerland · 8 centers
  • Kantonsspital Baden — Baden
  • Universitätsspital Basel — Basel
  • Lindenhofspital — Bern
  • Geneva University Hospitals — Geneva
  • Centre Hospitalier Universitaire Vaudois — Lausanne
  • Ente Ospedaliero Cantonale — Lugano
  • Réseau Hospitalier Neuchâtelois — Neuchâtel
  • Hôpital du Valais — Sion

Identifiers

NCT: NCT07140211 · 2025-00622

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗