Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy

NCT00721591 | Completed

• 1 other identifier: 13677B
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Recurrent Pregnancy Loss; Habitual abortion; Fetal demise; Antiphospholipid antibodies; Inherited thrombophilia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

A

Subjects opting for treatment with unfractionated heparin

B

Subjects opting for treatment with low molecular weight heparin

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 15 subjects prescribed dalteparin and 15 subjects prescribed unfractionated heparin, who are identified through the University of Chicago Recurrent Pregnancy Loss Program.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• University of British Columbia: collaborator

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma from subjects to obtain concentrations of heparin will be retained

MeSH Terms

Conditions

Fetal Death; Abortion, Habitual

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Abortion, Spontaneous

Study Officials

• Mary D. Stephenson, MD, MSc

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: March 1, 2005
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2014
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

US (1)