Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00721591
First received: July 22, 2008
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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. [ Time Frame: Pre-pregnancy, 1st, 2nd, 3d Trimester and post-partum ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma from subjects to obtain concentrations of heparin will be retained


Enrollment: 14
Study Start Date: March 2005
Estimated Study Completion Date: July 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Subjects opting for treatment with unfractionated heparin
B
Subjects opting for treatment with low molecular weight heparin

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.
  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721591

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
University of British Columbia
Investigators
Principal Investigator: Mary D. Stephenson, MD, MSc University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00721591     History of Changes
Other Study ID Numbers: 13677B
Study First Received: July 22, 2008
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Recurrent Pregnancy Loss
Habitual abortion
Fetal demise
Antiphospholipid antibodies
Inherited thrombophilia

Additional relevant MeSH terms:
Abortion, Habitual
Thrombophilia
Abortion, Spontaneous
Pregnancy Complications
Hematologic Diseases
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 26, 2014