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Clinical trial

A Pilot Randomized Controlled Trial of Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery

ID
Name
IRB_00167480
Description
The aim of this study is to evaluate the feasibility of randomizing individuals to low molecular weight heparin (enoxaparin) or no treatment following cesarean delivery. The investigators hypothesize that among eligible individuals, at least 35% will enroll, undergo randomization, and complete the allocated treatment group.
Trial arms
Trial start
2023-10-11
Estimated PCD
2024-07-01
Trial end
2024-07-01
Status
Recruiting
Phase
Early phase I
Treatment
Enoxaparin
Participants will receive weight-based dosing of enoxaparin at 0.5 mg/kg rounded to the nearest 10 mg every 12 hours based on delivery admission weight. Participants will receive therapy for 14 days.
Arms:
Enoxaparin
Size
150
Primary endpoint
Rate of eligible individuals enrolled and retained through full study procedures
6 Weeks
Eligibility criteria
Inclusion Criteria: * Cesarean delivery at the University of Utah Health Exclusion Criteria: * Contraindication to anticoagulation * Plan for therapeutic anticoagulation * Known renal dysfunction (creatinine clearance \<30mL/minute) * History of venous thromboembolism * High risk thrombophilia * Receipt of antepartum anticoagulation for \>2 weeks
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2024-05-08

1 organization

1 product

1 indication

Organization
University of Utah
Product
Enoxaparin
Indication
Thromboembolism