Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers
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|ClinicalTrials.gov Identifier: NCT01009723|
Recruitment Status : Unknown
Verified June 2012 by Esoterix Genetic Laboratories, LLC.
Recruitment status was: Active, not recruiting
First Posted : November 9, 2009
Last Update Posted : June 8, 2012
|Condition or disease|
The study will investigate whether the levels of individual maternal serum screening biomarkers, their combinations or temporal changes in the level can be associated with an increased risk of preterm delivery. Blood samples at three time points in pregnancy will be collected from the study participants. The first two blood draws will be timed to coincide with the first and second trimester maternal serum testing. The third blood draw will coincide with the screening for gestational diabetes. Pregnancy outcome information will be collected from the physicians and linked to the subject samples.
Subject samples from a case-control patient group will be analyzed by the serum screening biochemical assay. Statistical analyses will be performed to achieve the study objectives.
NOTE: This study is recruiting in Florida, USA. The laboratory data coordination is being performed in Massachusetts, USA and New Mexico, USA. New study locations will be identified on an ongoing basis.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Early Prediction Of Preterm Delivery By Measurement Of Maternal Serum Markers|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||July 2012|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009723
|United States, Massachusetts|
|Westborough, Massachusetts, United States, 01581|
|United States, New Mexico|
|Santa Fe, New Mexico, United States, 87505|
|Study Director:||Medical Monitor||Esoterix Genetic Laboratories, LLC|