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

May 24, 2023 updated by: Marc Blondon, University Hospital, Geneva
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Switzerland
      • Geneve, Switzerland, 1205
        • Geneva University Hospitals

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No treatment
No treatment.
Experimental: Enoxaparin
Enoxaparin 20-60mg o.d., according to bodyweight, for 10 days postpartum.
Drug: Enoxaparin
Prophylactic dose of enoxaparin once daily for 10 days after delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitement rate
Time Frame: 6 months
Number of study inclusion per month
6 months
Study participation
Time Frame: Within 48 hours after delivery
Proportion of eligible women who are presented the study and who accept to participate
Within 48 hours after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Venous thromboembolism
Time Frame: Within 90 day after delivery
Pulmonary embolism and deep vein thrombosis
Within 90 day after delivery
Bleeding
Time Frame: Within 90 day after delivery
Major and clinically relevant non-major bleeding
Within 90 day after delivery
Surgical site complication
Time Frame: Within 90 day of delivery
Cesarean section site complication
Within 90 day of delivery
Heparin-induced thrombocytopenia
Time Frame: Within 90 day of delivery
Within 90 day of delivery
Septic pelvic thrombophlebitis
Time Frame: Within 90 day of delivery
Within 90 day of delivery
All-cause mortality
Time Frame: Within 90 day of delivery
Within 90 day of delivery
Satisfaction with study intervention
Time Frame: After completion of the 10 days of study drug
Satisfaction based on TSQMII questionnaire
After completion of the 10 days of study drug

Collaborators and Investigators

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

Sponsor

University Hospital, Geneva

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)

May 3, 2022

Primary Completion (Actual)

March 13, 2023

Study Completion (Actual)

March 13, 2023

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UGeneva 2021-02350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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