Proteomic Assessment of Preterm Birth
PAPR
1 other identifier
observational
5,500
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2011
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 8, 2011
CompletedFirst Posted
Study publicly available on registry
June 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJune 11, 2015
June 1, 2015
3.7 years
June 8, 2011
June 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spontaneous Preterm Birth
August 2015
Study Arms (2)
Women with preterm delivery
Women without preterm delivery
Eligibility Criteria
Pregnant women who are receiving prenatal care.
You may qualify if:
- Subject is 18 years or older.
- Subject has a singleton pregnancy.
- Subject is able to provide consent.
You may not qualify if:
- Subject is pregnant with more than one fetus.
- There is a known or suspected fetal anomaly.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Maricopa Integrated Health System
Phoenix, Arizona, 85008, United States
San Diego Perinatal Clinic
San Diego, California, 92123, United States
Christiana Care Health System
Newark, Delaware, 19713-4248, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 25599-1651, United States
Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Regional Obstetrical Consultants
Chattanooga, Tennessee, 37403, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555-0156, United States
Intermountain Medical Center Suite 100, 5121 S. Cottonwood Street ,
Murray, Utah, 84107-5701, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
LDS Hospital
Salt Lake City, Utah, 84143-0001, United States
Related Publications (1)
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.
PMID: 21074133BACKGROUND
Biospecimen
Serum, plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Durlin E Hickok, MD, MPH
Sera Prognostics, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2011
First Posted
June 10, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2014
Study Completion
April 1, 2015
Last Updated
June 11, 2015
Record last verified: 2015-06