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

Sponsor

University Hospital, Geneva (Other)

Overall Status

Completed

CT.gov ID

NCT05878899

Collaborator

(none)

Enrollment

Location

Arms

10.3

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism	Drug: Enoxaparin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

77 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial

Actual Study Start Date :

May 3, 2022

Actual Primary Completion Date :

Mar 13, 2023

Actual Study Completion Date :

Mar 13, 2023

Arms and Interventions

Arm	Intervention/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.
No Intervention: No treatment No treatment.

Arm

Intervention/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.

No Intervention: No treatment

No treatment.

Outcome Measures

Primary Outcome Measures

Recruitement rate [6 months]
Number of study inclusion per month
Study participation [Within 48 hours after delivery]
Proportion of eligible women who are presented the study and who accept to participate

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geneva University Hospitals	Geneve		Switzerland	1205

Sponsors and Collaborators

University Hospital, Geneva

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marc Blondon, Principal Investigator, University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT05878899

Other Study ID Numbers:

UGeneva 2021-02350

First Posted:

May 26, 2023

Last Update Posted:

May 26, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thromboembolism

Venous Thromboembolism

Enoxaparin

Study Results

No Results Posted as of May 26, 2023