Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers

NCT01009723 | Unknown

• 1 other identifier: GGPS0001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Preterm Delivery

Keywords

Preterm delivery; preterm labor; maternal-fetal care; maternal serum screening biomarkers; alphafetoprotein; AFP; human chorionic gonadotropin; hCG; unconjugated estriol; Inhibin A; pregnancy associated plasma protein; PAPP-A; maternal screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population of the US

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Esoterix Genetic Laboratories, LLC: lead

Study Sites (2)

Integrated Genetics

Westborough, Massachusetts, 01581, United States

Location

Integrated Genetics

Santa Fe, New Mexico, 87505, United States

Location

Related 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. doi: 10.1067/mob.2002.125240.

  PMID: 12237660 BACKGROUND

• 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. doi: 10.1067/mob.2003.278.

  PMID: 12748511 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples from the study subjects

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Medical Monitor

  Esoterix Genetic Laboratories, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 9, 2009
• Study Start: March 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 8, 2012

Record last verified: 2012-06

Locations

US (2)