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Prophylactic Enoxaparin Dosing for Prevention of Venous Thromboembolism in Pregnancy.

NCT00878826 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-12-16

Study results available
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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.

Conditions

  • Venous Thrombosis

Interventions

DRUG

Enoxaparin

Drug: Enoxaparin 40 mg every morning until 36 weeks gestation. Drug: Enoxaparin 1 mg per kg every morning until 36 weeks gestation. Dose will increase at wt. increases. Drug: Enoxaparin dose taken by patient when enrolled until 36 weeks gestation.

Sponsors & Collaborators

Principal Investigators

  • Deirdre Judith Lyell · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-08-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00878826 on ClinicalTrials.gov