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

• Sponsor: University of California, Irvine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04861103
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 21.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Jul 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Factor Xa levels [4 hours after injection]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Irvine	Orange	California	United States	92868

Sponsors and Collaborators

• University of California, Irvine

Investigators

• Principal Investigator: Afshan Hameed, University of California, Irvine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Afshan B. Hameed, M.D., Maternal Fetal Medicine Physician, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT04861103
• Other Study ID Numbers: HS# 2019-5544
• First Posted: Apr 27, 2021
• Last Update Posted: Apr 27, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Enoxaparin

Study Results

No Results Posted as of Apr 27, 2021