An observational study in Preterm Birth and Premature Rupture of Membranes, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 4 sites in 4 countries. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Observational
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.
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 6,838 is above the median of 112 across 777 observational studies indexed under Premature Birth.
Browse Premature Birth studies →Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.
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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
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
Preterm delivery without labor because of the following reasons:
PROM leading to preterm delivery and with
EXCLUSION CRITERIA:
Consecutive pregnant women admitted with either: Preterm labor/delivery/PROM. Termdelivery without labor/spontaneous labor /chorioamnionitis/failed labor leading to c-section
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.
Time frame: After the study is closed to accrual
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)