Proteomic Assessment of Preterm Birth

NCT ID: NCT01371019

Last Updated: 2015-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with preterm delivery

No interventions assigned to this group

Women without preterm delivery

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sera Prognostics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Durlin E Hickok, MD, MPH

Role: STUDY_DIRECTOR

Sera Prognostics, Inc.

Locations

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Maricopa Integrated Health System

Phoenix, Arizona, United States

Site Status

San Diego Perinatal Clinic

San Diego, California, United States

Site Status

Christiana Care Health System

Newark, Delaware, United States

Site Status

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Regional Obstetrical Consultants

Chattanooga, Tennessee, United States

Site Status

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Site Status

Intermountain Medical Center Suite 100, 5121 S. Cottonwood Street ,

Murray, Utah, United States

Site Status

McKay-Dee Hospital Center

Ogden, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21074133 (View on PubMed)

Other Identifiers

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Sera - 004

Identifier Type: -

Identifier Source: org_study_id

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