Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery

Sponsor

University of Utah (Other)

Overall Status

Recruiting

CT.gov ID

NCT06118957

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thromboembolism	Drug: Enoxaparin	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 12, 2023

Anticipated Primary Completion Date :

Oct 12, 2028

Anticipated Study Completion Date :

Oct 12, 2029

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rate of eligible individuals enrolled and retained through full study procedures [6 Weeks]
Feasibility as defined by ≥35% enrollment of eligible individuals and retention ≥85% of enrolled individuals through all study procedures

Secondary Outcome Measures

Rate of venous thromboembolism [6 Weeks]
Objectively (by imaging) diagnosed deep vein thrombosis or pulmonary embolism
Rate of wound hematoma or infection [6 Weeks]
Clinically diagnosed
Rate of bleeding complications [6 Weeks]
Clinically diagnosed as readmission to hospital for bleeding or delayed postpartum hemorrhage (>24 hours after delivery)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator: Ann Bruno, MD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ann Bruno, Assistant Professor Obstetrics And Gynecology, University of Utah

ClinicalTrials.gov Identifier:

NCT06118957

Other Study ID Numbers:

IRB_00167480

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 9, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Ann Bruno, Assistant Professor Obstetrics And Gynecology, University of Utah

Thromboembolism

Enoxaparin

Cesarean delivery

Additional relevant MeSH terms:

Thromboembolism

Enoxaparin

Study Results

No Results Posted as of Nov 9, 2023