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NCT01371019 Clinical Trial

Proteomic Assessment of Preterm Birth

Preterm Birth Clinical Trial

— PAPR  

Official title:
Proteomic Assessment of Preterm Birth

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01371019
Other study ID # Sera - 004
Secondary ID
Status Completed
Phase N/A
First received June 8, 2011
Last updated June 9, 2015
Start date April 2011
Est. completion date April 2015

Study information
Verified date June 2015
Source Sera Prognostics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to to collect and store blood samples that will be utilized to develop a multimarker test to predict preterm delivery.

Recruitment information / eligibility
Status Completed
Enrollment 5500
Est. completion date April 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Subject is 18 years or older.

- Subject has a singleton pregnancy.

- Subject is able to provide consent.

Exclusion Criteria:

- Subject is pregnant with more than one fetus.

- There is a known or suspected fetal anomaly.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Regional Obstetrical Consultants Chattanooga Tennessee
United States Ohio State University Columbus Ohio
United States University of Texas Medical Branch at Galveston Galveston Texas
United States Intermountain Medical Center Suite 100, 5121 S. Cottonwood Street , Murray Utah
United States Christiana Care Health System Newark Delaware
United States McKay-Dee Hospital Center Ogden Utah
United States Maricopa Integrated Health System Phoenix Arizona
United States Oregon Health and Science University Portland Oregon
United States LDS Hospital Salt Lake City Utah
United States San Diego Perinatal Clinic San Diego California
United States Baystate Medical Center Springfield Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Sera Prognostics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Esplin MS, Merrell K, Goldenberg R, Lai Y, Iams JD, Mercer B, Spong CY, Miodovnik M, Simhan HN, van Dorsten P, Dombrowski M; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Proteomic identification of serum peptides predicting subsequent spontaneous preterm birth. Am J Obstet Gynecol. 2011 May;204(5):391.e1-8. doi: 10.1016/j.ajog.2010.09.021. Epub 2010 Nov 11. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Spontaneous Preterm Birth August 2015 No
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