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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

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

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Factor Xa levels in pregnant women with therapeutic Lovenox divided into three times a day dosing 		Therapeutic Lovenox dosing split into three times a day dosing for 5 day. Xa levels a measured.
  • Drug: Lovenox
    Three times a day dosing and measuring Xa peak and trough levels

Recruiting Locations

University of California Irvine
Orange, California 92868
Contact:
Lizette Spears
714.456.5694
lspiers@hs.uci.edu

More Details

NCT ID
NCT04861103
Status
Recruiting
Sponsor
University of California, Irvine

Study Contact

Lizette Spears
714.456.5694
lspiers@hs.uci.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center