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Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00342277
Enrollment
6838
Registered
2006-06-21
Start date
1999-12-21
Completion date
2016-05-05
Last updated
2023-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Rupture of Membranes, Preterm Birth

Keywords

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

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.

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.)

Design outcomes

Primary

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

Countries

Chile, Italy, South Korea, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026