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Anticoagulant

Low Molecular Weight Heparin for Blood Clot Prevention Post-Cesarean

Phase 2

Recruiting

Led By Ann Bruno, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial will compare low dose heparin to no treatment after C-section to see which is more effective. 35% of participants will take part and complete the trial. #medicine #cesarean #heparin

Who is the study for?

This trial is for individuals who have had a cesarean delivery at the University of Utah Health. It's not suitable for those with kidney issues (creatinine clearance <30mL/minute), a history of blood clots, severe thrombophilia, long-term anticoagulation treatment during pregnancy (>2 weeks), or any contraindication to blood-thinning medication.Check my eligibility

What is being tested?

The study is testing whether giving low molecular weight heparin (Enoxaparin) after a cesarean delivery is feasible compared to no treatment. Participants will be randomly assigned to either receive Enoxaparin or no postoperative intervention.See study design

What are the potential side effects?

Possible side effects of Enoxaparin include bleeding complications, bruising at injection sites, and allergic reactions. Since it's an anticoagulant, there's also an increased risk of prolonged bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of eligible individuals enrolled and retained through full study procedures

Secondary outcome measures

Rate of bleeding complications

Rate of venous thromboembolism

Rate of wound hematoma or infection

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EnoxaparinExperimental Treatment1 Intervention

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 II: No treatmentActive Control1 Intervention

Participants will receive no enoxaparin treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enoxaparin

2017

Completed Phase 4

~32400

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,539 Total Patients Enrolled

Ann Bruno, MDPrincipal InvestigatorUniversity of Utah

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there available positions in this medical experiment for individuals to join?

"As evidenced by the clinicaltrials.gov listing, this research is actively enrolling individuals. The initial posting of 10/12/2023 was recently modified on 10/31/2023."

Answered by AI

How many individuals are being qualified for the clinical trial?

"Affirmative. Clinicaltrials.gov records show that this research trial, which was initially uploaded on 10/12/2023, is currently open for recruitment. 150 participants are needed from 1 location."

Answered by AI

Are there any risks associated with Enoxaparin treatments?

"After careful consideration, our team at Power evaluated enoxaparin's safety levels to be a 2. This is because Phase 2 trials suggest that there are data points supporting the drug's security but none backing its effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery

Ann Bruno 2023. "Low Molecular Weight Heparin or no Treatment Following Cesarean Delivery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06118957.

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