Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

Preterm Birth Clinical Trial

Official title:

Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00342277
• Other study ID #: 999999056
• Secondary ID: OH99-CH-N056
• Status: Completed
• Start date: December 21, 1999
• Est. completion date: May 5, 2016

Study information

• Verified date: February 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6838
• Est. completion date: May 5, 2016
• Est. primary completion date: May 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

• 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.)

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Premature Rupture of Membranes
• Preterm Birth
• Rupture

Locations

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

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Chile,  Italy,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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