Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery

Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06118957
• Other study ID #: IRB_00167480
• Status: Recruiting
• Phase: Phase 2
• Start date: October 11, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: Emily Powers
• Phone: 801-587-0670
• Email: Emily.Powers[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 Weeks
Secondary	Rate of venous thromboembolism	Objectively (by imaging) diagnosed deep vein thrombosis or pulmonary embolism	6 Weeks
Secondary	Rate of wound hematoma or infection	Clinically diagnosed	6 Weeks
Secondary	Rate of bleeding complications	Clinically diagnosed as readmission to hospital for bleeding or delayed postpartum hemorrhage (>24 hours after delivery)	6 Weeks