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

Sponsor:	Eunice Kennedy Shriver 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

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

Estimated Enrollment:	6628
Study Start Date:	December 1999
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

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:	Yes

Criteria

INCLUSION CRITERIA:

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
1. acute inflammation;
2. chronic villitis;
3. vascular pathology;
4. no identifiable lesions.
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.
PROM leading to preterm delivery and with
1. acute inflammation;
2. chronic villitis;
3. vascular pathology;
4. no identifiable lesions.
Term delivery without labor and no identifiable lesions.
Term delivery in spontaneous labor and no identifiable lesions.
Term delivery with chorioamnionitis.
Term delivery with failed labor leading to ceasarean section.

EXCLUSION CRITERIA:

Refusal of written informed consent
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
Italy
Padova Hospital	Recruiting
Padova, Italy

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information

No publications provided

Study ID Numbers:	999999056, OH99-CH-N056
Study First Received:	June 19, 2006
Last Updated:	October 24, 2009
ClinicalTrials.gov Identifier:	NCT00342277 History of Changes
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:

Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

ClinicalTrials.gov processed this record on November 09, 2009