Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery

Phase 2

Completed

• Conditions: Thromboembolism
• Interventions: Drug: Enoxaparin

• Registration Number: NCT06118957
• Lead Sponsor: University of Utah

Brief 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.

Study Timeline

• Study Start: 2023-10-11
• Study First Submitted: 2023-10-31
• Study First Submitted QC: 2023-10-31
• Study First Posted: 2023-11-07
• Status Verified: 2024-07
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxaparin	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.

Primary Outcome Measures

Name	Time	Method
Rate of eligible individuals enrolled and retained through full study procedures	6 Weeks	Feasibility as defined by ≥35% enrollment of eligible individuals and retention ≥85% of enrolled individuals through all study procedures

Secondary Outcome Measures

Name	Time	Method
Rate of venous thromboembolism	6 Weeks	Objectively (by imaging) diagnosed deep vein thrombosis or pulmonary embolism
Rate of wound hematoma or infection	6 Weeks	Clinically diagnosed
Rate of bleeding complications	6 Weeks	Clinically diagnosed as readmission to hospital for bleeding or delayed postpartum hemorrhage (\>24 hours after delivery)

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States