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

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status and phase

Enrolling
Phase 4

Conditions

Anticoagulants
Pregnancy, High Risk

Treatments

Drug: Lovenox

Study type

Interventional

Funder types

Other

Identifiers

NCT04861103
20195544

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Factor Xa levels in pregnant women with therapeutic Lovenox divided into three times a day dosing
Experimental group
Description:
Therapeutic Lovenox dosing split into three times a day dosing for 5 day. Xa levels a measured.
Treatment:
Drug: Lovenox

Trial contacts and locations

1

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Central trial contact

Lizette Spears

Data sourced from clinicaltrials.gov

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