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Clinical Trials/NCT00342277
NCT00342277CompletedNot Applicable

Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)4 sites in 4 countries6,838 target enrollmentStarted: December 21, 1999Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
6,838
Locations
4
Primary Endpoint
To identify genes that are up- or down-regulated in preterm delivery and preterm PROM using microarray expression profiling.

Study Overview

Brief Summary

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). 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.

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). 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To identify genes that are up- or down-regulated in preterm delivery and preterm PROM using microarray expression profiling.

Time Frame: After the study is closed to accrual

Investigate the basic mechanisms of preterm labor by systematically cataloging the changes in expression levels of all expressed genes whose sequences are available.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor Class
Nih
Responsible Party
Sponsor

Study Sites (4)

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