Anticoagulation Profile in Pregnant Women Treated with Three Times a Day of Low Molecular Weight Heparin (LMWH)

Last updated: September 2, 2024
Sponsor: University of California, Irvine
Overall Status: Active - Recruiting

Phase

4

Condition

Drugs

Treatment

Lovenox

Clinical Study ID

NCT04861103
20195544
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Nulliparous or multiparous women with single intrauterine pregnancies who requiretherapeutic low molecular weight heparin during their pregnancy.

  • Participants must be age 18 or older.

Exclusion

Exclusion Criteria:

  • Women with multiples.

  • Women less than age 18

  • History of Heparin Induced Thrombocytopenia (HIT)

  • Allergy to enoxaparin

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Lovenox
Phase: 4
Study Start date:
October 01, 2020
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • University of California Irvine

    Orange, California 92868
    United States

    Active - Recruiting

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