Clinical Research Details

Clinical Research

Collection of Bio-fluid Samples from Pregnant Women for the Evaluation of Biomarkers for Preeclampsia Protocol: DLS Pregnant Women 2014

Study Description

The purpose of this research project is to improve the testing methods for the detection and management of Preeclampsia. Your sample(s) will be used to compare the performance of existing assays or tests to new ones being developed for patient use regarding this disease.

Your participation in this study may require you to have approximately 40mL of your blood drawn according to routine, universal blood collection procedures. You may also be asked to provide a urine sample. The specimen collection techniques that will be used are not experimental. Since this research project requires testing your bio-fluid for bio-markers of Preeclampsia, the collection of your bodily fluid is a mandatory component of the research. Once your sample has been collected, the specimen will be sent to the researcher and stored frozen until use. It is possible that specimens donated for this study may also be used in mandatory FDA studies that compare the effectiveness of the test with others currently being used for Preeclampsia detection and management. You will also need to answer several questions regarding your medical history. You may also be asked to provide additional clinical data from your scheduled future visits with your doctor up through delivery of your baby.

Inclusion/Exclusion Criteria

Willing to participate and agree to a one-time blood sample.

Investigators


Erin H. Burnett, M.D., FACOG
Obstetrics and Gynecology