Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy

Recurrent Pregnancy Loss Clinical Trial

Official title:

Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721591
• Other study ID #: 13677B
• Status: Completed
• Phase: N/A
• First received: July 22, 2008
• Last updated: October 31, 2016
• Start date: March 2005
• Est. completion date: July 2014

Study information

• Verified date: October 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abortion, Habitual
• Antiphospholipid Antibodies
• Fetal Death
• Fetal Demise
• Inherited Thrombophilia
• Recurrent Pregnancy Loss
• Thrombophilia

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	University of British Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No