Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial

Venous Thromboembolism Clinical Trial

— PP-HEP  

Official title:

Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05878899
• Other study ID #: UGeneva 2021-02350
• Status: Completed
• Phase: Phase 3
• Start date: May 3, 2022
• Est. completion date: March 13, 2023

Study information

• Verified date: May 2023
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 13, 2023
• Est. primary completion date: March 13, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Enoxaparin
Prophylactic dose of enoxaparin once daily for 10 days after delivery.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneve

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitement rate	Number of study inclusion per month	6 months
Primary	Study participation	Proportion of eligible women who are presented the study and who accept to participate	Within 48 hours after delivery
Secondary	Venous thromboembolism	Pulmonary embolism and deep vein thrombosis	Within 90 day after delivery
Secondary	Bleeding	Major and clinically relevant non-major bleeding	Within 90 day after delivery
Secondary	Surgical site complication	Cesarean section site complication	Within 90 day of delivery
Secondary	Heparin-induced thrombocytopenia		Within 90 day of delivery
Secondary	Septic pelvic thrombophlebitis		Within 90 day of delivery
Secondary	All-cause mortality		Within 90 day of delivery
Secondary	Satisfaction with study intervention	Satisfaction based on TSQMII questionnaire	After completion of the 10 days of study drug