Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00342277

Collaborator

(none)

6,838

Enrollment

Locations

1709.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth Premature Rupture of Membranes

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

6838 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

Actual Study Start Date :

Dec 21, 1999

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

To identify genes that are up- or down-regulated in preterm delivery and preterm PROM using microarray expression profiling. [After the study is closed to accrual]
Investigate the basic mechanisms of preterm labor by systematically cataloging the changes in expression levels of all expressed genes whose sequences are available.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
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;
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

Locations

	Site	City	State	Country	Postal Code
1	Wayne State University	Detroit	Michigan	United States	48201
2	Sotero del Rio Hospital	Puente Alto		Chile
3	Padova Hospital	Padova		Italy
4	Seoul National University	Seoul		Korea, Republic of