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Prophylactic Enoxaparin Dosing for Prevention of Venous Thromboembolism in Pregnancy.
Not Recruiting
Trial ID: NCT00878826
Purpose
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 dangerous and even life-threatening effects on the mother and fetus.
Enoxaparin is the preferred medicine to prevent clotting in pregnant patients who are at risk
for VTE, because it has been studied to be safe and effective in pregnancy without any harms
to the fetus. Although this medication is routinely used and is recommended by several
prominent medical groups, the optimal dosing for prevention of VTE is still unclear. The
range of standardly prescribed dosing regimens of Enoxaparin includes 40mg daily and 1mg/kg
daily, but these two dosing strategies have never been compared in a head to head fashion.
Official Title
Prophylactic Enoxaparin Dosing for Prevention of Venous Thromboembolism in Pregnancy.
Stanford Investigator(s)
Maurice L. Druzin
Professor of Obstetrics and Gynecology (Maternal Fetal Medicine) and, by courtesy, of Pediatrics
Eligibility
Inclusion Criteria:
1. >18 years of age
2. 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 Criteria:
1. Need for therapeutic-level anticoagulation as determined by physician
2. Renal disease as defined by serum creatinine >1.0
3. Weight >90kg
4. Allergy to enoxaparin
Intervention(s):
drug: Enoxaparin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mara Greenberg
4158672051