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

Pregnancy, High Risk Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04861103
• Other study ID #: HS# 2019-5544
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: July 31, 2026

Study information

• Verified date: May 2023
• Source: University of California, Irvine
• Contact: Lizette Spears
• Phone: 714.456.5694
• Email: lspiers[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulants
• Pregnancy, High Risk

Intervention

Drug:
• Lovenox
Three times a day dosing and measuring Xa peak and trough levels

Locations

Country	Name	City	State
United States	University of California Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Factor Xa levels		4 hours after injection