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.
Cervical Length Measurement
|Study Design:||Time Perspective: Prospective|
|Official Title:||Cervical Volume by Three-Dimensional Ultrasound as a Predictor of Preterm Delivery|
- Document cervical volume and funneling changes in women with preterm labor. Determine the relationship between cervical volume and funneling changes to the risk of preterm delivery. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Study inter- and intraobserver agreement for cervical and funnel volume measurements by 3DUS. Describe the sonographic anatomy of the cervix with 3DUS. Describe the changes in cervix anatomy and dimensions during normal labor at term with 3DUS. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Determine the effect of cervical cerclage on cervical and cervical funnel volume as assessed by 3DUS. Determine diagnostic value of cervical 3DUS in assessing risk of preterm delivery improved with information provided by biological markers. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
|Study Start Date:||March 1998|
The studies conducted from data obtained under this protocol have been used to identify prognostic indicators of pregnancy complications by three-dimensional ultrasound (3DUS). Pregnant women were prospectively studied to characterize cervical morphology and volume as predictors of preterm delivery risk. We will continue to correlate these results with maternal and fetal biological markers, placental pathology and pregnancy outcome. The performance of conventional two-dimensional endovaginal ultrasound with three-dimensional ultrasound findings has been examined. The information derived from this protocol is expected to improve our understanding of the nature and timing of cervical change in relation to normal and adverse pregnancy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00342550
|United States, Michigan|
|Hutzel Women's Hospital|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Roberto Romero, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|