Proteomic Assessment of Preterm Birth (PAPR)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sera Prognostics, Inc.
ClinicalTrials.gov Identifier:
NCT01371019
First received: June 8, 2011
Last updated: October 9, 2013
Last verified: October 2013
  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: 5500
Study Start Date: April 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 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 60 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  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: October 9, 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 August 20, 2014