Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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Recurrent Pregnancy Loss Habitual abortion Fetal demise Antiphospholipid antibodies Inherited thrombophilia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Subjects opting for treatment with unfractionated heparin

No interventions assigned to this group

B

Subjects opting for treatment with low molecular weight heparin

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary D. Stephenson, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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13677B

Identifier Type: -

Identifier Source: org_study_id