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

This study is currently recruiting participants.

Verified August 2012 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: December 19, 2012

Last verified: August 2012

History of Changes

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):

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)

Investigators

Principal Investigator:

Roberto Romero, M.D.

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

More Information

Publications:

Romero R, Salafia CM, Athanassiadis AP, Hanaoka S, Mazor M, Sepulveda W, Bracken MB. The relationship between acute inflammatory lesions of the preterm placenta and amniotic fluid microbiology. Am J Obstet Gynecol. 1992 May;166(5):1382-8.

Reilly DE. Preparation of objectives for continuing education programs. Occup Health Nurs. 1976 Dec;24(12):30-3. No abstract available.

Arias F, Rodriquez L, Rayne SC, Kraus FT. Maternal placental vasculopathy and infection: two distinct subgroups among patients with preterm labor and preterm ruptured membranes. Am J Obstet Gynecol. 1993 Feb;168(2):585-91.

ClinicalTrials.gov Identifier:	NCT00342277 History of Changes
Other Study ID Numbers:	999999056, OH99-CH-N056
Study First Received:	June 19, 2006
Last Updated:	December 19, 2012
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, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 22, 2013

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