Preterm Delivery Clinical Trial
Official title:
Early Prediction Of Preterm Delivery By Measurement Of Maternal Serum Markers
This protocol seeks to longitudinally collect blood samples from a cohort of pregnant women. The biological specimens will be used to determine the predictive power of biochemical markers routinely used in Down syndrome screening in the assessment of patient's risk of preterm delivery.
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.
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Observational Model: Case Control, Time Perspective: Prospective
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