Proteomic Assessment of Preterm Birth (PAPR)

June 9, 2015 updated by: Sera Prognostics, Inc.
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

5500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Maricopa Integrated Health System
    • California
      • San Diego, California, United States, 92123
        • San Diego Perinatal Clinic
    • Delaware
      • Newark, Delaware, United States, 19713-4248
        • Christiana Care Health System
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 25599-1651
        • University of North Carolina At Chapel Hill
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Regional Obstetrical Consultants
    • Texas
      • Galveston, Texas, United States, 77555-0156
        • University of Texas Medical Branch at Galveston
    • Utah
      • Murray, Utah, United States, 84107-5701
        • Intermountain Medical Center Suite 100, 5121 S. Cottonwood Street ,
      • Ogden, Utah, United States, 84403
        • McKay-Dee Hospital Center
      • Salt Lake City, Utah, United States, 84143-0001
        • LDS Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women who are receiving prenatal care.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Women with preterm delivery
Women without preterm delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spontaneous Preterm Birth
Time Frame: August 2015
August 2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sera Prognostics, Inc.

Investigators

  • Study Director: Durlin E Hickok, MD, MPH, Sera Prognostics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

June 8, 2011

First Posted (ESTIMATE)

June 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sera - 004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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