Ignite Creation Date:
2024-05-05 @ 10:00 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01009723
Status:
UNKNOWN
Last Update Posted:
2012-06-08
First Post:
2009-11-05
Brief Title:
Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers
Sponsor:
Esoterix Genetic Laboratories LLC
Organization:
Esoterix Genetic Laboratories LLC
Study Overview
Official Title:
Early Prediction Of Preterm Delivery By Measurement Of Maternal Serum Markers
Status:
UNKNOWN
Status Verified Date:
2012-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients risk of preterm delivery
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None