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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04861103
Other study ID # HS# 2019-5544
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 1, 2020
Est. completion date July 31, 2026

Study information

Verified date May 2023
Source University of California, Irvine
Contact Lizette Spears
Phone 714.456.5694
Email lspiers@hs.uci.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pregnancy is associated with a increased risk of developing blood clots. There is nearly a 5 times greater risk of developing a blood clot in pregnancy. Lovenox is a medication that helps to prevent the body from developing clots. It is safe to use in pregnancy. Previous studies have demonstrated that despite recommendation of Lovenox, to prevent blood clots, the majority of patient's (70 to 90%) did not receive adequate levels of Lovenox at times throughout the day, which likely increases the risk of developing clots. The increase in blood volume and increase in kidney function that occurs in pregnancy may contribute to the inadequate levels. Currently the recommendation for pregnant and nonpregnant patients requiring Lovenox, is to calculate the daily dose of Lovenox and split the dose, giving half in the morning and the other half in the evening. This research study proposes that due to changes in the body during pregnancy that the daily Lovenox dosing be split into three times a day to achieve more consistent levels of Lovenox than twice a day in pregnant women.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date July 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Women with multiples. - Women less than age 18 - History of Heparin Induced Thrombocytopenia (HIT) - Allergy to enoxaparin

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lovenox
Three times a day dosing and measuring Xa peak and trough levels

Locations

Country Name City State
United States University of California Irvine Orange California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Factor Xa levels 4 hours after injection
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