Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

NCT00342277 | Completed

• 2 other identifiers: 999999056OH99-CH-N056
• Study Type: observational
• Target: 6,838
• Locations: 4 countries
• Sites: 4

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.

Conditions

Preterm Birth; Premature Rupture of Membranes

Keywords

Genetic Risk Factors; Tissue Specific Expression; Quantitative Real Time PCR; Preterm Birth; Expression Profiling; Natural History

Outcome Measures

Primary Outcomes (1)

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

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

  After the study is closed to accrual

Study Arms (1)

Pregnant Women

Consecutive pregnant women admitted with either: Preterm labor/delivery/PROM. Termdelivery without labor/spontaneous labor /chorioamnionitis/failed labor leading to c-section

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant women aged 15 years and older at 18 - 36 weeks of gestation admitted with the following diagnoses:@@@1) preterm labor with intact membranes@@@2) preterm delivery without labor@@@3) PROM leading to preterm delivery@@@4) Term deliveries without labor/spontaneous labor/with chorioamnionitis/with failed labor leading to cesarean section

You may qualify if:

• 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
• acute inflammation;
• chronic villitis;
• vascular pathology;
• no identifiable lesions.
• Preterm delivery without labor because of the following reasons:
• pre-eclampsia;
• abruptio placentae;
• fetal anomalies;
• Other complications (e.g. automobile accidents) that necessitate immediate delivery.
• PROM leading to preterm delivery and with
• acute inflammation;
• chronic villitis;
• vascular pathology;

You may not qualify if:

• Refusal of written informed consent
• Fetal or maternal conditions mandating immediate delivery (i.e. fetal distress, significant hemorrhage, etc.)

Sponsors & Collaborators

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

Study Sites (4)

Wayne State University

Detroit, Michigan, 48201, United States

Location

Sotero del Rio Hospital

Puente Alto, Chile

Location

Padova Hospital

Padua, Italy

Location

Seoul National University

Seoul, South Korea

Location

MeSH Terms

Conditions

Premature Birth; Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Roberto Romero, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: December 21, 1999
• Primary Completion: May 5, 2016
• Study Completion: May 5, 2016
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

US (1); IT (1); CL (1); KR (1)