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Proteomic Assessment of Preterm Birth (PAPR)

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ClinicalTrials.gov Identifier: NCT01371019
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : June 11, 2015
Sponsor:
Information provided by (Responsible Party):
Sera Prognostics, Inc.

Brief 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.

Condition or disease
Preterm Birth

Study Type : Observational
Actual Enrollment : 5500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Proteomic Assessment of Preterm Birth
Study Start Date : April 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : April 2015

Group/Cohort
Women with preterm delivery
Women without preterm delivery



Primary Outcome Measures :
  1. Spontaneous Preterm Birth [ Time Frame: August 2015 ]

Biospecimen Retention:   Samples Without DNA
Serum, plasma


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371019


Locations
United States, Arizona
Maricopa Integrated Health System
Phoenix, Arizona, United States, 85008
United States, California
San Diego Perinatal Clinic
San Diego, California, United States, 92123
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19713-4248
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 25599-1651
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Regional Obstetrical Consultants
Chattanooga, Tennessee, United States, 37403
United States, Texas
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555-0156
United States, Utah
Intermountain Medical Center Suite 100, 5121 S. Cottonwood Street ,
Murray, Utah, United States, 84107-5701
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
LDS Hospital
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.

Publications:
Responsible Party: Sera Prognostics, Inc.
ClinicalTrials.gov Identifier: NCT01371019     History of Changes
Other Study ID Numbers: Sera - 004
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015

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

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