Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342550
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2006-06-19
Brief Title:
Cervical Volume by Three-Dimensional Ultrasound as a Predictor of Preterm Delivery
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cervical Volume by Three-Dimensional Ultrasound as a Predictor of Preterm Delivery
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH98-CH-N016 | None | None | None |