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

NCT04861103 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 20195544
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Factor Xa levels

  4 hours after injection

Study Arms (1)

Factor Xa levels in pregnant women with therapeutic Lovenox divided into three times a day dosing

EXPERIMENTAL

Therapeutic Lovenox dosing split into three times a day dosing for 5 day. Xa levels a measured.

Drug: Lovenox

Interventions

Lovenox DRUG

Three times a day dosing and measuring Xa peak and trough levels

Factor Xa levels in pregnant women with therapeutic Lovenox divided into three times a day dosing

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Afshan Hameed

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lizette Spears

CONTACT

714.456.5694; lspiers@hs.uci.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medicine Physician

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: October 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-09

Locations

US (1)