search
Back to results

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

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Geneva University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enoxaparin

No treatment

Arm Description

Enoxaparin 20-60mg o.d., according to bodyweight, for 10 days postpartum.

No treatment.

Outcomes

Primary Outcome Measures

Recruitement rate
Number of study inclusion per month
Study participation
Proportion of eligible women who are presented the study and who accept to participate

Secondary Outcome Measures

Venous thromboembolism
Pulmonary embolism and deep vein thrombosis
Bleeding
Major and clinically relevant non-major bleeding
Surgical site complication
Cesarean section site complication
Heparin-induced thrombocytopenia
Septic pelvic thrombophlebitis
All-cause mortality
Satisfaction with study intervention
Satisfaction based on TSQMII questionnaire

Full Information

First Posted
March 6, 2023
Last Updated
May 24, 2023
Sponsor
University Hospital, Geneva
search

1. Study Identification

Unique Protocol Identification Number
NCT05878899
Brief Title
Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial
Acronym
PP-HEP
Official Title
Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
March 13, 2023 (Actual)
Study Completion Date
March 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enoxaparin
Arm Type
Experimental
Arm Description
Enoxaparin 20-60mg o.d., according to bodyweight, for 10 days postpartum.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No treatment.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
Prophylactic dose of enoxaparin once daily for 10 days after delivery.
Primary Outcome Measure Information:
Title
Recruitement rate
Description
Number of study inclusion per month
Time Frame
6 months
Title
Study participation
Description
Proportion of eligible women who are presented the study and who accept to participate
Time Frame
Within 48 hours after delivery
Secondary Outcome Measure Information:
Title
Venous thromboembolism
Description
Pulmonary embolism and deep vein thrombosis
Time Frame
Within 90 day after delivery
Title
Bleeding
Description
Major and clinically relevant non-major bleeding
Time Frame
Within 90 day after delivery
Title
Surgical site complication
Description
Cesarean section site complication
Time Frame
Within 90 day of delivery
Title
Heparin-induced thrombocytopenia
Time Frame
Within 90 day of delivery
Title
Septic pelvic thrombophlebitis
Time Frame
Within 90 day of delivery
Title
All-cause mortality
Time Frame
Within 90 day of delivery
Title
Satisfaction with study intervention
Description
Satisfaction based on TSQMII questionnaire
Time Frame
After completion of the 10 days of study drug

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneve
ZIP/Postal Code
1205
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial

We'll reach out to this number within 24 hrs