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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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
566 Previous Clinical Trials
1,933,036 Total Patients Enrolled
Afshan HameedPrincipal InvestigatorUniversity of California, Irvine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am pregnant and need low molecular weight heparin for treatment.I am 18 years old or older.I am pregnant with more than one baby.I am a woman under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Factor Xa levels in pregnant women with therapeutic Lovenox divided into three times a day dosing
Awards:
This trial has 5 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.