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Cervical Volume by Three-Dimensional Ultrasound as a Predictor of Preterm Delivery
This study is ongoing, but not recruiting participants.
Study NCT00342550   Information provided by National Institutes of Health Clinical Center (CC)
First Received: June 19, 2006   Last Updated: October 16, 2009   History of Changes

June 19, 2006
October 16, 2009
March 1998
November 1999   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00342550 on ClinicalTrials.gov Archive Site
 
 
 
Cervical Volume by Three-Dimensional Ultrasound as a Predictor of Preterm Delivery
Cervical Volume by Three-Dimensional Ultrasound as a Predictor of Preterm Delivery

Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators have reported that ultrasound evaluation of the cervix can predict the risk of preterm delivery. Three-dimensional ultrasound may provide additional information about how to best counsel parents about the chances of premature birth. This technology has the capability for accurate volume measurements of irregular structures that is superior to conventional ultrasound. Therefore, it is possible that three-dimensional ultrasound methods may better characterize cervical changes and the risk for preterm delivery.

Our protocol will attempt to identify prognostic indicators of adverse pregnancy outcome by three-dimensional ultrasound. A maximum of 680 pregnant women with the diagnosis of preterm labor will be prospectively studied to characterize cervical morphology and volume as predictors of preterm delivery risk. These results will be correlated with placental pathology and pregnancy outcome. We will also compare the performance of conventional two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings. This information is expected to improve our understanding about the nature and timing of cervical volume changes in relation to pregnancy outcome.

Preterm labor is a leading cause of perinatal morbidity and mortality. Several investigators have reported that ultrasound evaluation of the cervix can predict the risk of preterm delivery. Three-dimensional ultrasound may provide additional information about how to best counsel parents about the chances of premature birth. This technology has the capability for accurate volume measurements of irregular structures that is superior to conventional ultrasound. Therefore, it is possible that three-dimensional ultrasound methods may better characterize cervical changes and the risk for preterm delivery.

Our protocol will attempt to identify prognostic indicators of adverse pregnancy outcome by three-dimensional ultrasound. A maximum of 680 pregnant women with the diagnosis of preterm labor will be prospectively studied to characterize cervical morphology and volume as predictors of preterm delivery risk. These results will be correlated with maternal and fetal biological markers, placental pathology and pregnancy outcome. We will also compare the performance of conventional two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings. This information is expected to improve our understanding about the nature and timing of cervical volume changes in relation to pregnancy outcome.

 
Observational
 
  • Pregnancy
  • Preterm Delivery
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
680
 
November 1999   (final data collection date for primary outcome measure)
  • INCLUSION CRITERIA - PRETERM LABOR AND INTACT MEMBRANES:

Singleton gestation;

Estimated gestational age between 20 and 35 weeks' gestation;

Intact membranes;

Signed informed consent for voluntary participation and serial endovaginal scans.

EXCLUSION CRITERIA - PRETERM LABOR AND INTACT MEMBRANES:

Absent fetal cardiac activity;

Desire not to have vaginal ultrasound scans.

INCLUSION CRITERIA - PATIENTS AT RISK FOR PRETERM DELIVERY:

Estimated gestational age between 16 and less than 24 weeks gestation;

Planned cerclage placement due to increased preterm labor risk (i.e., short cervix or dilated cervix);

Intact membranes;

Signed informed consent for voluntary participation and serial endovaginal scans.

EXCLUSION CRITERIA - PATIENTS AT RISK FOR PRETERM DELIVERY:

Absent fetal cardiac activity;

Desire not to have vaginal ultrasound scans.

INCLUSION CRITERIA - PATIENTS IN SPONTANEOUS LABOR AT TERM:

Term gestation (greater than 37 weeks);

Intact membranes;

Cervical dilatation less than 2 cm;

Signed informed consent for voluntary participation and serial endovaginal scans.

EXCLUSION CRITERIA - PATIENTS IN SPONTANEOUS LABOR AT TERM:

Absent fetal cardiac activity;

Desire not to have vaginal ultrasound scans.

INCLUSION CRITERIA - PATIENTS UNDERGOING ELECTIVE INDUCTION OF LABOR:

Term gestation (greater than 37 weeks);

Intact membranes;

Signed informed consent for voluntary participation and serial endovaginal scans.

EXCLUSION CRITERIA - PATIENTS UNDERGOING ELECTIVE INDUCTION OF LABOR:

Absent fetal cardiac activity;

Desire not to have vaginal ultrasound scans.

Female
 
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00342550
 
999998016, OH98-CH-N016
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 
 
National Institutes of Health Clinical Center (CC)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP