NCT06118957

Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Venous thromboembolism (VTE) is a major contributor to maternal morbidity and mortality. The first two weeks postpartum are the highest risk period for VTE during pregnancy and the postpartum period. Cesarean delivery is a known risk factor for VTE. In the United States, postpartum prophylaxis with low molecular weight heparin (e.g., enoxaparin) is commonly used during the first 10-14 days after delivery. Enoxaparin has not been demonstrated as an effective intervention to prevent postpartum VTE after cesarean delivery. Before larger scale studies may be completed, a better understanding of ability to randomize individuals to this intervention is needed. This study aims to evaluate the feasibility of randomizing individuals after cesarean delivery to the receipt of enoxaparin prophylaxis or no treatment.

Conditions

• Thromboembolism

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2023-10-11
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2023-11-07
• Last updated: 2025-09-04
• Results posted: 2025-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study