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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy, High Risk; Anticoagulants
• Intervention / Treatment: Drug: Lovenox

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lizette Spears; Phone Number: 714.456.5694; Email: lspiers@hs.uci.edu

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • University of California Irvine
      • Contact: Lizette Spears; Phone Number: 714-456-5694; Email: lspiers@hs.uci.edu
      • Contact: Phuong Linh L Huynh; Phone Number: 714.456.6155; Email: plhuynh@hs.uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Lovenox; Three times a day dosing and measuring Xa peak and trough levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Factor Xa levels	4 hours after injection

Collaborators and Investigators

• Sponsor: University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): July 31, 2026

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin
• Other Study ID Numbers: HS# 2019-5544

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No