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| 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 |
| Study Type: | Observational |
| Official Title: | Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition |
| Estimated Enrollment: | 6628 |
| Study Start Date: | December 1999 |
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 |
Consecutive patients admitted with the following diagnoses from four different ethnic groups (Hispanic, African American, Asian, and Caucasian):
Preterm labor with intact membranes and with
Preterm delivery without labor because of the following reasons:
PROM leading to preterm delivery and with
EXCLUSION CRITERIA:
Contacts and Locations| Contact: Roberto Romero, M.D. | (313) 993-2700 | romeror@mail.nih.gov |
| 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 | |||||
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 |
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