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Microarray Expression Profiling to Identify Stereotypic mRNA Profiles for Preterm Delivery in Order to Unravel the Biological Mechanisms
This study is currently recruiting participants.
Study NCT00342277   Information provided by National Institutes of Health Clinical Center (CC)
First Received: June 19, 2006   Last Updated: October 24, 2009   History of Changes

June 19, 2006
October 24, 2009
December 1999
November 2014   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00342277 on ClinicalTrials.gov Archive Site
 
 
 
Microarray Expression Profiling to Identify Stereotypic mRNA Profiles for Preterm Delivery in Order to Unravel the Biological Mechanisms
Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

The understanding of the biological mechanisms underlying preterm birth is very limited, making prevention of preterm birth difficult. The incidence of preterm birth worldwide varies between 6% to 11% in singleton pregnancies and 64-93% of preterm deliveries occur after the spontaneous onset of labor (preterm labor) (1). The risk factors associated with preterm birth include demographic variables such as ethnic group, past obstetric history, and complications of the current pregnancy such as infection and fetal congenital anomalies. The current study aims to investigate the basic mechanisms of preterm labor by systematically cataloging the changes in expression levels of all expressed genes whose sequences are available. The goals will be accomplished by using microarray technology followed by quantitative real-time PCR, in situ PCR, in situ hybridization and proteomics.

The understanding of the biological mechanisms underlying preterm birth is very limited, making prevention of preterm birth difficult. The incidence of preterm birth worldwide varies between 6% to 11% in singleton pregnancies and 64-93% of preterm deliveries occur after the spontaneous onset of labor (preterm labor) (1). The risk factors associated with preterm birth include demographic variables such as ethnic group, past obstetric history, and complications of the current pregnancy such as infection and fetal congenital anomalies. The current study aims to investigate the basic mechanisms of preterm labor by systematically cataloging the changes in expression levels of all expressed genes whose sequences are available. The goals will be accomplished by using microarray technology followed by subsequent confirmative or complementary analyses.

 
Observational
 
Preterm Birth
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
6628
 
November 2014   (final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:

Consecutive patients admitted with the following diagnoses from four different ethnic groups (Hispanic, African American, Asian, and Caucasian):

  1. Preterm labor with intact membranes and with

    1. acute inflammation;
    2. chronic villitis;
    3. vascular pathology;
    4. no identifiable lesions.
  2. Preterm delivery without labor because of the following reasons:

    1. pre-eclampsia;
    2. abruptio placentae;
    3. fetal anomalies;
    4. Other complications (e.g. automobile accidents) that necessitate immediate delivery.
  3. PROM leading to preterm delivery and with

    1. acute inflammation;
    2. chronic villitis;
    3. vascular pathology;
    4. no identifiable lesions.
  4. Term delivery without labor and no identifiable lesions.
  5. Term delivery in spontaneous labor and no identifiable lesions.
  6. Term delivery with chorioamnionitis.
  7. Term delivery with failed labor leading to ceasarean section.

EXCLUSION CRITERIA:

  1. Refusal of written informed consent
  2. Fetal or maternal conditions mandating immediate delivery (i.e. fetal distress, significant hemorrhage, etc.)
Female
 
Yes
Contact: Roberto Romero, M.D. (313) 993-2700 romeror@mail.nih.gov
United States,   Italy
 
NCT00342277
 
999999056, OH99-CH-N056
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 
 
National Institutes of Health Clinical Center (CC)
August 2009

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