Proteomic Assessment of Preterm Birth (PAPR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sera Prognostics, Inc.
ClinicalTrials.gov Identifier:
NCT01371019
First received: June 8, 2011
Last updated: June 9, 2015
Last verified: June 2015

June 8, 2011
June 9, 2015
April 2011
December 2014   (final data collection date for primary outcome measure)
Spontaneous Preterm Birth [ Time Frame: August 2015 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01371019 on ClinicalTrials.gov Archive Site
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Proteomic Assessment of Preterm Birth
Proteomic Assessment of Preterm Birth
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Serum, plasma
Probability Sample
Pregnant women who are receiving prenatal care.
Preterm Birth
Not Provided
  • Women with preterm delivery
  • Women without preterm delivery
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5500
April 2015
December 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01371019
Sera - 004
Yes
Not Provided
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Sera Prognostics, Inc.
Sera Prognostics, Inc.
Not Provided
Study Director: Durlin E Hickok, MD, MPH Sera Prognostics, Inc.
Sera Prognostics, Inc.
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP