Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-11

Study Completion Date

2024-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Prophylactic Low-molecular Weight Heparin Dosing on Clotting Parameters Following Cesarean Delivery

NCT04305756

Thromboembolism Postpartum DVT Thrombosis

COMPLETED NA

Prophylactic Methylergonovine for Twin Cesarean

NCT05772156

Twin; Complicating Pregnancy Postpartum Hemorrhage

COMPLETED PHASE4

Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean

NCT03364491

Obstetrical Complications Hemorrhage Labor and Delivery

COMPLETED PHASE3

Impact of Intraoperative Cell Salvage

NCT06240117

Peripartum Anemia

TERMINATED NA

Coagulation Factor Changes Associated With Postpartum Hysterectomies

NCT00456547

Obstetric Labor Complications Hemorrhage Complications; Cesarean Section

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thromboembolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Enoxaparin

Intervention Type 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.

No treatment

Participants will receive no enoxaparin treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes