Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-03

Study Completion Date

2023-03-13

Brief Summary

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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

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Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Enoxaparin

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

Group Type EXPERIMENTAL

Enoxaparin

Intervention Type DRUG

Prophylactic dose of enoxaparin once daily for 10 days after delivery.

No treatment

No treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enoxaparin

Prophylactic dose of enoxaparin once daily for 10 days after delivery.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No