Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Chicago.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Chicago
Collaborator:
University of British Columbia
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00721591
First received: July 22, 2008
Last updated: July 2, 2010
Last verified: July 2010
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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:
MedlinePlus related topics:
Blood Thinners
Drug Information available for:
Heparin
U.S. FDA Resources
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
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | March 2010 (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:
- 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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721591
Contacts
| Contact: Mary D. Stephenson, MD, MSc | 773 834-1167 | |
| Contact: Patricia A. Schultz, RN, MHA | 773 834-2106 | pschultz@babies.bsd.uchicago.edu |
Locations
| United States, Illinois | |
| The University of Chicago | Recruiting |
| 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: | Mary D. Stephenson, MD, MSc, The University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00721591 History of Changes |
| Other Study ID Numbers: | 13677B |
| Study First Received: | July 22, 2008 |
| Last Updated: | July 2, 2010 |
| 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 June 18, 2013