NCT04861103

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Lovenox	Three times a day dosing and measuring Xa peak and trough levels

Timeline

• Start date: 2020-10-01
• Primary completion: 2026-12-31
• Completion: 2027-07-31
• First posted: 2021-04-27
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study