Recruiting

Lovenox

Sponsor:

UCLA

Code:

NCT04861103

Conditions

Pregnancy, High Risk

Anticoagulants

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Lovenox

Study Details

Brief 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.

Conditions

Pregnancy, High Risk

Anticoagulants

Study ID

NCT04861103

Start date

Oct 1, 2020

Status verified date

Sep, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Lovenox

Three times a day dosing and measuring Xa peak and trough levels

Primary outcome measure

  • Factor Xa levels [ Time Frame: 4 hours after injection ]

Central Contacts and Locations

Central contacts

Locations

University of California Irvine

Recruiting

Orange, California, United States, 92868

Contacts

More Information

Sponsor

University of California, Irvine

Last update posted

Oct 29, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2025-10-29.