Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers

• Conditions: Preterm Delivery

• Registration Number: NCT01009723
• Lead Sponsor: Esoterix Genetic Laboratories, LLC

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 patient's 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.

Study Timeline

• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-06
• Study First Posted: 2009-11-09
• Study Start: 2010-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-08
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

• The participant understands the nature of the study and its requirements. To this end, we will require that the participants have command of the English language.
• The participant consents to and signs the approved consent form.
• The participant is 18 years of age or older.
• The participant has a singleton pregnancy.
• The participant is planning on continuing the pregnancy.
• The participant has intent to clinically test for Down syndrome risk.
• The participant consents to the study at the first trimester of her pregnancy.
• The participant understands the nature of the study and its requirements. To this end, we will require that the participants have command of either the English or Spanish language.

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Integrated Genetics; 🇺🇸 Santa Fe, New Mexico, United States