Trial intelligence / Profile preview

Enoxaparin vs No Treatment Post-Cesarean

NCT06118957Phase 2

Key facts

Status: Completed
Start: Oct 2023
Primary completion: Jul 2024
Countries: 1
Sponsor: University of Utah
Modality: Recombinant Proteins and Enzymes

Drugs: enoxaparin
Conditions: venous thromboembolism (VTE)

Overview

Phase 2, randomised, open-label trial of enoxaparin in venous thromboembolism (VTE) (2 arms), sponsored by University of Utah. Primary endpoint: Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures at 6 weeks. Started Oct 2023; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Enoxaparin Arm
Enoxaparin 0.5 mg/kg q12h for 14 days
No Treatment Arm
No anticoagulant prophylaxis

Who it enrols

Postpartum individuals who underwent cesarean delivery at the University of Utah Health, excluding those with contraindications to anticoagulation, renal dysfunction, history of VTE, or high-risk thrombophilia.

Endpoints

Primary

Rate of Eligible Individuals Enrolled and Retained Through Full Study Procedures6 weeks

Secondary

Rate of Venous Thromboembolism6 weeks
Rate of Wound Hematoma or Infection6 weeks
Rate of Bleeding Complications6 weeks

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