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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 19, 2006 | ||||
| Last Updated Date | October 24, 2009 | ||||
| Start Date ICMJE | December 1999 | ||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00342277 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Microarray Expression Profiling to Identify Stereotypic mRNA Profiles for Preterm Delivery in Order to Unravel the Biological Mechanisms | ||||
| Official Title ICMJE | Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition | ||||
| 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% 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE | Preterm Birth | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 6628 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Consecutive patients admitted with the following diagnoses from four different ethnic groups (Hispanic, African American, Asian, and Caucasian):
EXCLUSION CRITERIA:
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| Gender | Female | ||||
| Ages | |||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Italy | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00342277 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 999999056, OH99-CH-N056 | ||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE | |||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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