Trials / Completed
CompletedNCT00721591
Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 14 (actual)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- Female
- Age
- 18 Years – 44 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Recurrent Pregnancy Loss
- Fetal Demise
- Abortion, Habitual
- Antiphospholipid Antibodies
- Inherited Thrombophilia
Timeline
- Start date
- 2005-03-01
- Primary completion
- 2013-01-01
- Completion
- 2014-07-01
- First posted
- 2008-07-24
- Last updated
- 2016-11-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00721591. Inclusion in this directory is not an endorsement.