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Microarray Expression Profiling to Identify Stereotypic mRNA Profiles for Preterm Delivery in Order to Unravel the Biological Mechanisms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier:
NCT00342277
First received: June 19, 2006
Last updated: December 7, 2016
Last verified: October 2016

June 19, 2006
December 7, 2016
December 1999
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Complete list of historical versions of study NCT00342277 on ClinicalTrials.gov Archive Site
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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%-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
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Preterm Birth
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11128
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  • 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
15 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Italy
Chile,   Korea, Republic of
 
NCT00342277
999999056, OH99-CH-N056
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Roberto Romero, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health Clinical Center (CC)
October 2016

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