Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers

Preterm Delivery Clinical Trial

Official title:

Early Prediction Of Preterm Delivery By Measurement Of Maternal Serum Markers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01009723
• Other study ID #: GGPS0001
• Status: Active, not recruiting
• Phase: N/A
• First received: November 5, 2009
• Last updated: June 7, 2012
• Start date: March 2010
• Est. completion date: July 2012

Study information

• Verified date: June 2012
• Source: Esoterix Genetic Laboratories, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Preterm Delivery

Locations

Country	Name	City	State
United States	Integrated Genetics	Santa Fe	New Mexico
United States	Integrated Genetics	Westborough	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Esoterix Genetic Laboratories, LLC

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chitayat D, Farrell SA, Huang T, Meier C, Wyatt PR, Summers AM. Double-positive maternal serum screening results for down syndrome and open neural tube defects: An indicator for fetal structural or chromosomal abnormalities and adverse obstetric outcomes. Am J Obstet Gynecol. 2002 Sep;187(3):758-63. — View Citation

Lepage N, Chitayat D, Kingdom J, Huang T. Association between second-trimester isolated high maternal serum maternal serum human chorionic gonadotropin levels and obstetric complications in singleton and twin pregnancies. Am J Obstet Gynecol. 2003 May;188(5):1354-9. — View Citation