Status:
COMPLETED
Evaluation of Pre-dose and Post-dose Anti-factor Xa Levels With Enoxaparin Use During Pregnancy
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
Long Beach Memorial Medical Center
Conditions:
Pregnancy
Eligibility:
FEMALE
18-45 years
Brief Summary
Venous thromboembolism is a condition that causes formation of blood clots in the body. It may have life threatening consequences if the leg veins, lungs or the brain blood vessels are involved. In pr...
Detailed Description
Study Design This is a prospective, non-blinded, pilot study of gravid patients receiving treatment doses of enoxaparin therapy. Subjects Subjects will include pregnant women at all gestational ages ...
Eligibility Criteria
Inclusion
- Nulliparous or multiparous women with intrauterine pregnancies who are receiving twice daily treatment doses of enoxaparin (1 mg/kg ± 20% SC BID).
- Subjects who consent to the study.
Exclusion
- Women who are not pregnant.
- Women who are receiving enoxaparin at prophylactic doses (i.e., 30 mg twice daily or 40 mg daily).
- Women who are currently receiving another LMWH or UFH.
- Women who are receiving other concomitant anticoagulant medications, such as warfarin, lepirudin, or argatroban.
- Subjects who are unable or unwilling to give informed consent.
- Women who, in the judgment of the investigators, would not be in the best interest of the patient to participate in the study.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00319176
Start Date
April 1 2004
End Date
December 1 2007
Last Update
February 8 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806