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Microarray Expression Profiling to Identify Stereotypic mRNA Profiles for Preterm Delivery in Order to Unravel the Biolo...

This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), December 2007

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00342277
  Purpose

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.


Condition
Preterm Birth

U.S. FDA Resources

Study Type:   Observational
Official Title:   Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   6628
Study Start Date:   December 1999

Detailed Description:

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.

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria
  • 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.)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00342277

Contacts
Contact: Roberto Romero, M.D.     (313) 993-2700     romeror@mail.nih.gov    

Locations
United States, Michigan
Hutzel Women's Hospital     Recruiting
      Detroit, Michigan, United States, 48201
Chile
Sotero del Rio Hospital     Recruiting
      Santiago, Chile
Italy
Padova Hospital, Obsterics/Gynecology Unit     Recruiting
      Padova, Italy
Korea, Republic of
Seoul National University     Recruiting
      Seoul, Korea, Republic of

Sponsors and Collaborators
  More Information

Study ID Numbers:   999999056, OH99-CH-N056
First Received:   June 19, 2006
Last Updated:   July 18, 2008
ClinicalTrials.gov Identifier:   NCT00342277
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Premature Rupture of Membranes  
Genetic Risk Factors  
Tissue Specific Expression  
Quantitative Real Time PCR  
Preterm Birth
Expression Profiling
Microarrays

Study placed in the following topic categories:
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Rupture
Fetal Membranes, Premature Rupture
Premature Birth

ClinicalTrials.gov processed this record on September 05, 2008




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