Prophylactic Enoxaparin Dosing for Prevention of Venous Thromboembolism in Pregnancy.

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Enoxaparin

Criteria

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