Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk (MUM-VTE)

June 9, 2026 updated by: University Hospital, Brest

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
      • Bordeaux, France, 33000
        • Not yet recruiting
        • CHU de Bordeaux, Groupe Pellegrin, Centre Aliénor d'Aquitaine
        • Contact:
      • Brest, France, 29200
      • Clamart, France, 92140
        • Not yet recruiting
        • Hôpital Béclère, AP-HP
        • Contact:
      • Clermont-Ferrand, France, 63000
        • Not yet recruiting
        • CHU de Clermont Ferrand Site Estaing
        • Contact:
      • La Roche-sur-Yon, France, 85000
        • Not yet recruiting
        • CH Départemental de Vendée
        • Contact:
      • Le Kremlin-Bicêtre, France, 94720
        • Not yet recruiting
        • Hôpital Bicêtre, AP-HP
        • Contact:
      • Marseille, France, 13015
        • Not yet recruiting
        • Hôpital Nord Marseille, AP-HM
        • Contact:
      • Morlaix, France, 29600
        • Not yet recruiting
        • Centre Hospitalier des Pays de Morlaix
        • Contact:
      • Nancy, France, 54000
        • Not yet recruiting
        • CHRU de Nancy
        • Contact:
      • Nantes, France, 44000
      • Paris, France, 75014
        • Not yet recruiting
        • Groupe hospitalier Paris saint Joseph
        • Contact:
          • Elie AZRIA, MD, PhD
          • Phone Number: +33 01 44 12 81 04
          • Email: eazria@ghpsj.fr
      • Paris, France, 75010
        • Not yet recruiting
        • Hôpital Lariboisière, AP-HP
        • Contact:
      • Pau, France, 64000
      • Périgueux, France, 24019
      • Quimper, France, 29000
        • Not yet recruiting
        • Centre Hospitalier de Cornouaille Quimper Concarneau
        • Contact:
      • Rennes, France, 35203
      • Saint-Priest-en-Jarez, France, 42270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group

Pharmacological thromboprophylaxis using LMWH at preventive dosage. The choice of subcutaneous LMWH depends on the practice of each center:

  • Enoxaparine 4000 UI (weight > 90 kg 6000 UI)
  • Tinzaparine 3500 UI (weight > 90 kg 4500 UI)
  • Dalteparine 5000 UI (weight > 90 kg 7500 UI)
  • Nadroparine 2850 UI (weight > 90 kg 3800 UI).

All patients can have compression stockings
Drug: Low molecular weight heparin

Pharmacological thromboprophylaxis using LMWH at preventive dosage. The choice of subcutaneous LMWH depends on the practice of each center:

  • Enoxaparine 4000 UI (weight > 90 kg 6000 UI)
  • Tinzaparine 3500 UI (weight > 90 kg 4500 UI)
  • Dalteparine 5000 UI (weight > 90 kg 7500 UI)
  • Nadroparine 2850 UI (weight > 90 kg 3800 UI).
No Intervention: Control group
No pharmacological thromboprophylaxis. All patients can have compression stockings.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Symptomatic VTE (DVT or non-fatal or fatal PE)
Time Frame: 6 weeks
Blindly adjudicated objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE) ) during the first 6-week postpartum period
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptomatic VTE (DVT or non-fatal or fatal PE)
Time Frame: 3 months
blindly adjudicated objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE) during 3-month follow-up period after delivery (entire study period).
3 months
Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis)
Time Frame: 6 weeks
Blindly adjudicated major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis) during 6-week study treatment period
6 weeks
Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis)
Time Frame: 3 months
Blindly adjudicated major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis) during 3-month follow-up after delivery.
3 months
Clinically relevant non-major bleeding
Time Frame: 6 weeks
Blindly adjudicated clinically relevant non-major bleeding during 6-week study treatment period
6 weeks
Clinically relevant non-major bleeding
Time Frame: 3 months
Blindly adjudicated clinically relevant non-major bleeding during 3-month follow-up after delivery.
3 months
Net Clinical benefit
Time Frame: 6 weeks
The net clinical benefit of study treatment (composite of symptomatic VTE and major or clinically relevant non major bleeding) during 6-week postpartum period
6 weeks
Net Clinical benefit
Time Frame: 3 months
The net clinical benefit of study treatment (composite of symptomatic VTE and major or clinically relevant non major bleeding) during 3-month follow-up after delivery
3 months
Number of Thrombocytopenia
Time Frame: 6 weeks
Cases of heparin induced thrombocytopenia associated with LMWH during 6-week study treatment period.
6 weeks
Mortality
Time Frame: 6 weeks
Blindly adjudicated mortality of all causes during 6-week study treatment period
6 weeks
Mortality
Time Frame: 3 months
Blindly adjudicated mortality of all causes during 3-month follow-up period after delivery.
3 months
VTE suspicion
Time Frame: 6 weeks
Number of VTE suspicion in interventional and control arm during 6-week study treatment period
6 weeks
VTE suspicion
Time Frame: 3 months
Number of VTE suspicion in interventional and control arm during 3-month follow-up period after delivery.
3 months
Treatment compliance
Time Frame: 6 weeks
Treatment compliance during 6-week study treatment period based on Girerd questionnaire
6 weeks
Objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE)
Time Frame: 6 weeks
- Blindly adjudicated objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE) during the first 6-week postpartum period (i.e., study treatment period) in clinically relevant prespecified subgroups (caesarean section, obesity, age 35 y, smoker during pregnancy, pre-term birth < 37, pre-eclampsia, postpartum infection, postpartum hemorrhage, VTE family history).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emmanuelle LE MOIGNE, MD, PhD, CHU de Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 29BRC22.0254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning five years and ending fifteen years following the final study report completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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