Deirdre J. Lyell, M.D.
Prophylactic Enoxaparin dosing for prevention of venous thromboembolism in pregnancy ? a prospective randomized trial
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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. We hope to compare 2 different Enoxaparin dosing strategies for prevention of VTE in pregnancy, to find out whether 40mg once daily is inferior to, equally efficacious to, or superior to a dosing strategy of 1mg/kg daily. This knowledge would be very important in helping medical care providers choose the best dosing strategy for their pregnant patients at increased risk of VTE.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Enoxaparin 40mg once daily vs. 1mg/kg daily
Phase:
Phase 2/Phase 3Eligibility
Ages Eligible for Study:
18 years to 55 yearsGenders Eligible for Study:
FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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: ??3 pregnancy losses in the 1st trimester, ??2 pregnancy losses/stillbirth in 2nd
trimester, ??1 pregnancy loss/IUFD in the 3rd trimester, IUGR, abruptio placentae, or severe
pre-Eclampsia prior to 34 weeks gestation.
Key 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
Additional Study Details
Official Title:
Prophylactic Enoxaparin dosing for prevention of venous thromboembolism in pregnancy ? a prospective randomized trialAnticipated start date:
5/1/2009Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
PreventionAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- Proportion of patients in each arm who have anti-XA levels within appropriate prophylactic range
Secondary Outcomes:
- Corrolation of anti-XA levels with renal function. Adverse outcomes including bleeding events, thromboembolic events, side effects, tolerability.
Total Number to be Enrolled:
64Total Number to be Enrolled at Stanford:
64More Information
Secondary ID(s):
- 15957
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/27/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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