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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04861103
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : April 27, 2021
Information provided by (Responsible Party):
Afshan B. Hameed, M.D., University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Pregnancy, High Risk Anticoagulants Drug: Lovenox Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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

Primary Outcome Measures :
  1. Factor Xa levels [ Time Frame: 4 hours after injection ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04861103

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Contact: Lizette Spears 714.456.5694

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United States, California
University of California Irvine Recruiting
Orange, California, United States, 92868
Contact: Lizette Spears    714-456-5694   
Contact: Phuong Linh L Huynh    714.456.6155   
Sponsors and Collaborators
University of California, Irvine
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Principal Investigator: Afshan Hameed University of California, Irvine
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Responsible Party: Afshan B. Hameed, M.D., Maternal Fetal Medicine Physician, University of California, Irvine Identifier: NCT04861103    
Other Study ID Numbers: HS# 2019-5544
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action