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

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.

Study Overview

• Status: Completed
• Conditions: Thromboembolism
• Intervention / Treatment: Drug: Enoxaparin

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: No treatment; Participants will receive no enoxaparin treatment.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Venous Thromboembolism	Objectively (by imaging) diagnosed deep vein thrombosis or pulmonary embolism	6 Weeks
Rate of Wound Hematoma or Infection	Clinically diagnosed	6 Weeks
Rate of Bleeding Complications	Clinically diagnosed as readmission to hospital for bleeding or delayed postpartum hemorrhage (>24 hours after delivery)	6 Weeks

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Ann Bruno, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Enoxaparin; Thromboembolism; Cesarean delivery
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thromboembolism; Carbohydrates; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Enoxaparin
• Other Study ID Numbers: IRB_00167480

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes