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Proteomic Assessment of Preterm Birth (PAPR)

This study is currently recruiting participants.
Verified August 2012 by Sera Prognostics, Inc.
Sponsor:
Information provided by (Responsible Party):
Sera Prognostics, Inc.
ClinicalTrials.gov Identifier:
NCT01371019
First received: June 8, 2011
Last updated: February 26, 2013
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
Preterm Birth

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Proteomic Assessment of Preterm Birth

Further study details as provided by Sera Prognostics, Inc.:

Primary Outcome Measures:
  • Spontaneous Preterm Birth

Biospecimen Retention:   Samples Without DNA

Serum, plasma


Estimated Enrollment: 5000
Study Start Date: April 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women with preterm delivery
Women without preterm delivery

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Pregnant women who are receiving prenatal care.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371019

Contacts
Contact: Angela Fox, MS, LCGC 206-465-0905 afox@seraprognostics.com
Contact: Durlin E Hickok, MD, MPH (206) 323-7071 dhickok@seraprognostics.com

Locations
United States, Arizona
Maricopa Integrated Health System Recruiting
Phoenix, Arizona, United States, 85008
United States, California
San Diego Perinatal Clinic Recruiting
San Diego, California, United States, 92123
United States, Delaware
Christiana Care Health System Recruiting
Newark, Delaware, United States, 19713-4248
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 25599-1651
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
Regional Obstetrical Consultants Recruiting
Chattanooga, Tennessee, United States, 37403
United States, Texas
University of Texas Medical Branch at Galveston Recruiting
Galveston, Texas, United States, 77555-0156
United States, Utah
Intermountain Medical Center Suite 100, 5121 S. Cottonwood Street , Active, not recruiting
Murray, Utah, United States, 84107-5701
McKay-Dee Hospital Center Active, not recruiting
Ogden, Utah, United States, 84403
LDS Hospital Active, not recruiting
Salt Lake City, Utah, United States, 84143-0001
Sponsors and Collaborators
Sera Prognostics, Inc.
Investigators
Study Director: Durlin E Hickok, MD, MPH Sera Prognostics, Inc.
  More Information

Publications:

Responsible Party: Sera Prognostics, Inc.
ClinicalTrials.gov Identifier: NCT01371019     History of Changes
Other Study ID Numbers: Sera - 004
Study First Received: June 8, 2011
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sera Prognostics, Inc.:
Preterm Birth, Proteomics

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 16, 2013