Clinical trial NCT00342277: Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition
Official title: Microarray Expression Profiling to Identify Stereotypic mRNA Profiles in Human Parturition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Premature Rupture of Membranes
Keywords: Genetic Risk Factors
Tissue Specific Expression
Quantitative Real Time PCR
Preterm Birth
Expression Profiling
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 6838
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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.)

Primary outcomes:
measure: To identify genes that are up- or down-regulated in preterm delivery and preterm PROM using microarray expression profiling.
timeFrame: After the study is closed to accrual
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Puente Alto
country: Chile
facility: Sotero del Rio Hospital
city: Padova
country: Italy
facility: Padova Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Roberto Romero, M.D.
role: PRINCIPAL_INVESTIGATOR
References: