Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth; Premature Rupture of Membranes

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). 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.

• Study Type: Observational
• Enrollment (Actual): 6838

Contacts and Locations

Study Locations

• Chile
  • Puente Alto, Chile
    • Sotero del Rio Hospital
• Italy
  • Padova, Italy
    • Padova Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University
• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

• INCLUSION CRITERIA:

Consecutive patients admitted with the following diagnoses from four different ethnic groups (Hispanic, African American, Asian, and Caucasian):

1. Preterm labor with intact membranes and with

   1. acute inflammation;
   2. chronic villitis;
   3. vascular pathology;
   4. no identifiable lesions.

2. 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.

3. PROM leading to preterm delivery and with

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

EXCLUSION CRITERIA:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 1999
• Primary Completion (Actual): May 5, 2016
• Study Completion (Actual): May 5, 2016

Study Registration Dates

• First Submitted: June 19, 2006
• First Submitted That Met QC Criteria: June 19, 2006
• First Posted (Estimate): June 21, 2006

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Natural History; Preterm Birth; Genetic Risk Factors; Tissue Specific Expression; Quantitative Real Time PCR; Expression Profiling
• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Rupture; Premature Birth; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: 999999056; OH99-CH-N056