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

June 8, 2011
October 9, 2013
April 2011
December 2013   (final data collection date for primary outcome measure)
Spontaneous Preterm Birth
Not Provided
Complete list of historical versions of study NCT01371019 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
 
Active, not recruiting
5500
February 2014
December 2013   (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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01371019
Sera - 004
No
Sera Prognostics, Inc.
Sera Prognostics, Inc.
Not Provided
Study Director: Durlin E Hickok, MD, MPH Sera Prognostics, Inc.
Sera Prognostics, Inc.
October 2013

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