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

NCT ID: NCT07140211

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

9200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2030-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Venous Thromboembolism (VTE) Postpartum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Low-molecular-weight heparin

Group Type EXPERIMENTAL

Low-dose low-molecular-weight heparin

Intervention Type 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.

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Marc Blondon

OTHER

Sponsor Role lead

Responsible Party

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Marc Blondon

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Marc Blondon

Role: CONTACT

(+41).22.372.92.92

Other Identifiers

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2025-00622

Identifier Type: -

Identifier Source: org_study_id

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