Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery

University of Utah64 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Thromboembolism

Interventions

EnoxaparinDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Utah

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures

Feasibility as defined by ≥35% enrollment of eligible individuals and retention ≥85% of enrolled individuals through all study procedures

Time frame: A pilot randomized controlled trial of low molecular weight heparin or no treatment following cesarean delivery NCT06118957 July 30, 2025 6 weeks

Secondary Outcomes

Rate of Venous Thromboembolism

Objectively (by imaging) diagnosed deep vein thrombosis or pulmonary embolism

Time frame: 6 Weeks

Rate of Wound Hematoma or Infection

Clinically diagnosed

Time frame: 6 Weeks

Rate of Bleeding Complications

Clinically diagnosed as readmission to hospital for bleeding or delayed postpartum hemorrhage (\>24 hours after delivery)

Time frame: 6 Weeks

Data from ClinicalTrials.gov

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