Skip to main content
OpenTrials
Completed

NCT Number: NCT00342277

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Sotero del Rio Hospital, Puente Alto, Chile

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.)

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Important dates

Study start
1999
Primary completion
2016
Study completion
2016
First posted
Jun 21, 2006
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.