Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy

Completed

• Conditions: Recurrent Pregnancy Loss; Abortion, Habitual; Fetal Demise; Inherited Thrombophilia; Antiphospholipid Antibodies

• Registration Number: NCT00721591
• Lead Sponsor: University of Chicago

Brief Summary

To determine, through pharmacokinetic parameters, the ideal dosing protocol for dalteparin (a low molecular weight heparin) and unfractionated heparin for women desiring pregnancy who have evidence of an acquired (specifically, antiphospholipid syndrome) or inherited thrombophilia.

Detailed Description

This study's specific objectives include:

1. Evaluating pharmacokinetic (concentration-time) and pharmacodynamic (concentration- effect) parameters for dalteparin and UFH prior to pregnancy, during the 1st, 2nd and 3rd trimesters and postpartum, using revised dosing protocols based on previous study.

2. Determining therapeutic response to the heparins, i.e. live birth rate and lack of maternal or fetal complications, in relation to drug exposure, based on AUC.

3. Documenting maternal and fetal complications during pregnancy for dalteparin and UFH, using the revised dosing protocols.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2008-07-22
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-24
• Primary Completion: 2013-01
• Study Completion: 2014-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

Inclusion Criteria

• Two or more consecutive, otherwise unexplained miscarriages under 10 weeks of gestation, or, an otherwise unexplained intrauterine fetal demise of at least 10 weeks of gestation, and,
• Persistently positive antiphospholipid antibodies, or, presence of Factor V Leiden, or, Prothrombin 20210A, or, antithrombin, protein S, or protein C deficiency, or, hyperhomocysteinemia associated with the methylenetetrahydrofolate reductase (MTHFR) polymorphism.

Exclusion Criteria

• Inability or refusal to give written informed consent.
• Inability or refusal to self-administer heparin throughout pregnancy.
• Hemoglobin value below 9.5 g/dL
• Heparin use is contraindicated.
• Renal disease.
• Documented history of thrombosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The best dosing strategy for either unfractionated or low molecular weight heparin will be the one exhibiting the best balance between a modified Akaike information criterion value, residual sum of squares, and coefficient of determination.	Pre-pregnancy, 1st, 2nd, 3d Trimester and post-partum

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States