Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00721591

Enrollment

Registered

2008-07-24

Start date

2005-03-31

Completion date

2014-07-31

Last updated

2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 44 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results