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

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT04861103
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Anticoagulants
  • Pregnancy, High Risk

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Lovenox — DRUG
    Three times a day dosing and measuring Xa peak and trough levels

Study Details

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.

Key Dates

Start date
Oct 1, 2020
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California IrvineOrangeCalifornia92868
Lizette Spears
[email protected]
714.456.5694
Phuong Linh L Huynh
[email protected]
714.456.6155

Find similar trials in Orange, CA

By research site
University of California Irvine· Orange, CA

Related Studies