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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00342277
First received: June 19, 2006
Last updated: June 19, 2014
Last verified: June 2014
  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

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: 11128
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%-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:   Yes
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Italy
Padova Hospital Recruiting
Padova, Italy
Sponsors and Collaborators
Investigators
Principal Investigator: Roberto Romero, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00342277     History of Changes
Other Study ID Numbers: 999999056, OH99-CH-N056
Study First Received: June 19, 2006
Last Updated: June 19, 2014
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

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on October 23, 2014