Status:
COMPLETED
Prophylactic Enoxaparin Dosing for Prevention of Venous Thromboembolism in Pregnancy.
Lead Sponsor:
Stanford University
Conditions:
Venous Thrombosis
Eligibility:
FEMALE
18-55 years
Phase:
PHASE2
PHASE3
Brief Summary
Enoxaparin is a type of low molecular weight heparin (LMWH), or anticoagulant, used to prevent and treat blood clots. Formation of blood clots, or venous thromboemboli (VTE) in pregnancy can have dang...
Detailed Description
When pregnant patients are diagnosed by their physician as being at risk for VTE, or when they enter the perinatology practice on a previously-prescribed prophylactic enoxaparin regimen, they will be ...
Eligibility Criteria
Inclusion
- \>18 years of age
- Warrants prophylaxis against venous thromboembolism in pregnancy according to American College of
- Obstetrics and Gynecology Practice Bulletin 2000, reaffirmed in 2008:
- history of idiopathic thrombosis
- history of thrombosis related to pregnancy or oral contraceptive use
- history of thrombosis accompanied by an underlying thrombophilia other than homozygous for the factor V Leiden mutation, heterozygous for both the factor V Leiden and the prothrombin G20210A mutation, or AT-III deficiency
- without a history of thrombosis but who have an underlying thrombophilia and a strong family history of thrombosis
- Known thrombophilia except for those listed above, with a history of adverse pregnancy outcome (APO) as defined by: ¡Ý3 pregnancy losses in the 1st trimester, ¡Ý2 pregnancy losses/stillbirth in 2nd trimester, ¡Ý1 pregnancy loss/intrauterine fetal demise (IUFD) in the 3rd trimester, intrauterine growth restriction (IUGR), abruptio placentae, or severe pre-Eclampsia prior to 34 weeks gestation.
Exclusion
- Need for therapeutic-level anticoagulation as determined by physician
- Renal disease as defined by serum creatinine \>1.0
- Weight \>90kg
- Allergy to enoxaparin
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00878826
Start Date
May 1 2009
End Date
October 1 2014
Last Update
December 16 2016
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305