Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery

NCT06118957 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB_00167480
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboembolism

Keywords

Thromboembolism; Enoxaparin; Cesarean delivery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of Venous Thromboembolism

  6 Weeks

• Rate of Wound Hematoma or Infection

  6 Weeks

• Rate of Bleeding Complications

  6 Weeks

Study Arms (2)

Enoxaparin

EXPERIMENTAL

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

No treatment

NO INTERVENTION

Participants will receive no enoxaparin treatment.

Interventions

Enoxaparin DRUG

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.

Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cesarean delivery at the University of Utah Health

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Thromboembolism

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Elizabeth Turner, MPH, Senior Regulatory Coordinator
• Organization: University of Utah Obgyn

elizabeth.e.turner@hsc.utah.edu

8012018929

Study Officials

• Ann Bruno, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Obstetrics And Gynecology

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: October 11, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Locations

US (1)