Summary

Eligibility
for females ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Orange, California
Dates
study started
completion around
Principal Investigator
by Afshan Hameed

Description

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.

Keywords

Pregnancy, High Risk, Anticoagulants, Enoxaparin, Lovenox

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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.

You CAN'T join if...

  • Women with multiples.
  • Women less than age 18
  • History of Heparin Induced Thrombocytopenia (HIT)
  • Allergy to enoxaparin

Location

  • University of California Irvine accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Afshan Hameed
    Health Sciences Professor, Obstetrics and Gynecology, School of Medicine. Authored (or co-authored) 56 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT04861103
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 12 study participants
Last Updated