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Completed

NCT Number: NCT06118957

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.

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Key information

Conditions

Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Rate of Eligible Individuals Enrolled and Retained Through Full 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

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

Secondary outcomes

  1. Rate of Venous Thromboembolism

    Time frame: 6 Weeks

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

  2. Rate of Wound Hematoma or Infection

    Time frame: 6 Weeks

    Clinically diagnosed

  3. Rate of Bleeding Complications

    Time frame: 6 Weeks

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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2023
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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