Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial
PP-HEP
1 other identifier
interventional
77
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2022
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 3, 2022
CompletedFirst Submitted
Initial submission to the registry
March 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2023
CompletedFirst Posted
Study publicly available on registry
May 26, 2023
CompletedMay 26, 2023
May 1, 2023
10 months
March 6, 2023
May 24, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Recruitement rate
Number of study inclusion per month
6 months
Study participation
Proportion of eligible women who are presented the study and who accept to participate
Within 48 hours after delivery
Secondary Outcomes (7)
Venous thromboembolism
Within 90 day after delivery
Bleeding
Within 90 day after delivery
Surgical site complication
Within 90 day of delivery
Heparin-induced thrombocytopenia
Within 90 day of delivery
Septic pelvic thrombophlebitis
Within 90 day of delivery
- +2 more secondary outcomes
Study Arms (2)
Enoxaparin
EXPERIMENTALEnoxaparin 20-60mg o.d., according to bodyweight, for 10 days postpartum.
No treatment
NO INTERVENTIONNo treatment.
Interventions
Eligibility Criteria
You may qualify if:
- ≥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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Geneva University Hospitals
Geneva, 1205, Switzerland
Related Publications (1)
Blondon M, Claver M, Celetta E, Righini M, de Tejada BM. Preventing Postpartum Venous Thromboembolism With Low-Molecular-Weight Heparin: The PP-HEP Pilot Randomised Controlled Trial. BJOG. 2025 Jan;132(1):35-43. doi: 10.1111/1471-0528.17943. Epub 2024 Sep 5.
PMID: 39238110DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 6, 2023
First Posted
May 26, 2023
Study Start
May 3, 2022
Primary Completion
March 13, 2023
Study Completion
March 13, 2023
Last Updated
May 26, 2023
Record last verified: 2023-05