Trial Information

Summary: Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Thrombophilia-associated Pregnancy Loss

This trial is supported by the University of Chicago Women's Board and the University of Chicago's National Institute of Health (NIH) General Clinical Research Center (GCRC).

Study Summary

Some women with a history of pregnancy loss are also at risk for developing blood clots in pregnancy (a condition called thrombophilia). A thrombophilia can be acquired, specifically antiphospholipid syndrome (APS), or inherited. The standard treatment in pregnancy is heparin and low dose aspirin, in some cases. The University of Chicago and Dr. Mary Stephenson are conducting a clinical study to further clarify the best doses of heparin that are advisable for use in treating this problem in pregnancy. While heparin has been shown to improve pregnancy success in such women, there has been limited research on how heparins are handled by the body during pregnancy. The evaluation of the body's handling of a drug is called pharmacokinetics.

Participants will be allowed to choose whether they wish to be treated with unfractionated heparin (UFH) or low molecular weight heparin (LMWH). The only study procedure beyond the care that is routinely provided includes 12-13 hour visits to the University of Chicago's General Clinical Research Center once prior to pregnancy, once during each trimester and once after delivery. During these study visits, a small amount of blood will be drawn at specific times to measure the effect of the heparin over time.

Dr. Stephenson and her research staff will monitor the pregnancy closely during the first trimester. The patient will then be transferred back to the referring physician for the remainder of the pregnancy.

There will be no charge for the study-related procedures. The cost of routine care prior to, during and after pregnancy will be the participant’s responsibility. The study procedures will all be performed at the University of Chicago Hospitals.

The benefits of participating in this trial include the possibility of helping Dr. Stephenson better understand how a participant's body handles heparin. This understanding is especially important if/when heparin is given with another pregnancy. Additionally, Dr. Stephenson and her research team will use the data from this study to determine the best dosing for heparin use in pregnancy. This may benefit many other women who require heparin in pregnancy.

Participation Details

Initial selection criteria for the study include:

• Women between 18 and 44 years of age
• Diagnosis of antiphospholipid syndrome or an inherited thrombophilia.
• Able to safely undergo treatment with heparin.

Study Director: Mary D. Stephenson, MD, MSc
Department: Obstetrics and Gynecology

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Trial listings updated: June 1, 2008 at 5:46:19 AM