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Anticoagulant

Low Molecular Weight Heparin for Blood Clot Prevention in Pregnancy

Phase 4
Recruiting
Led By Afshan Hameed
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Nulliparous or multiparous women with single intrauterine pregnancies who require therapeutic low molecular weight heparin during their pregnancy.
Participants must be age 18 or older.
Must not have
Women less than age 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
All Individual Drugs Already Approved

Summary

This trial looks at how split dosing of Lovenox in pregnant women may reduce their risk of blood clots.

Who is the study for?
This trial is for pregnant women aged 18 or older who need blood thinners to prevent clots and have a single baby in the womb. It's not for those under 18, with multiple babies, a history of bad reactions to heparin (HIT), or allergies to enoxaparin.
What is being tested?
The study tests if taking Lovenox three times daily instead of twice can maintain safer levels in pregnant women due to their body changes. The goal is consistent anticoagulation to reduce clot risks without over-thinning the blood.
What are the potential side effects?
Lovenox may cause bleeding, bruising at injection sites, irritation, and rarely allergic reactions. In pregnancy, it's chosen because it's less likely to harm the baby compared to other blood thinners.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am pregnant and need low molecular weight heparin for treatment.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am a woman under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Factor Xa levels in pregnant women with therapeutic Lovenox divided into three times a day dosingExperimental Treatment1 Intervention
Therapeutic Lovenox dosing split into three times a day dosing for 5 day. Xa levels a measured.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enoxaparin
FDA approved

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
563 Previous Clinical Trials
1,932,550 Total Patients Enrolled
Afshan HameedPrincipal InvestigatorUniversity of California, Irvine

Media Library

Lovenox (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04861103 — Phase 4
Pregnancies Research Study Groups: Factor Xa levels in pregnant women with therapeutic Lovenox divided into three times a day dosing
Pregnancies Clinical Trial 2023: Lovenox Highlights & Side Effects. Trial Name: NCT04861103 — Phase 4
Lovenox (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04861103 — Phase 4
~3 spots leftby Dec 2025
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