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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pregnancy, High Risk Anticoagulants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lovenox

Intervention Type DRUG

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

Interventions

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Lovenox

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

Intervention Type DRUG

Eligibility Criteria

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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.