Anticoagulants, Pregnancy, High Risk
Conditions
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.
Interventions
DRUGLovenox
Three times a day dosing and measuring Xa peak and trough levels
Sponsors
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Factor Xa levels | 4 hours after injection |
Countries
United States
Contacts
Primary ContactLizette Spears
Outcome results
None listed