Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340002
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2006-06-19
Brief Title:
Fetal Anatomy by Three-Dimensional Ultrasound
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:
Fetal Anatomy by Three-Dimensional Ultrasound
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:
A major goal of perinatal care is to accurately diagnose fetal anomalies prior to birth This capability allows clinicians to make prudent decisions regarding antepartum care delivery site and postnatal therapy Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the fetus This technique allows one to scan through a digital ultrasound volume dataset visualize organs from different perspectives measure volumes and render anatomical features through computer processing However the accurate characterization of fetal anomalies by this technique must be interpreted in relation to normal fetal anatomy at different stages of pregnancy
We are continuing to develop an image reference library of fetal anatomy by identifying key diagnostic features by three-dimensional ultrasound A cross-sectional observational study of up to 1400 fetuses will catalog a broad spectrum of congenital malformations at various gestational ages The protocol will include up to 400 examples of normal fetal anatomy by three-dimensional ultrasonography
All cases will be placed into a digital image database For each anomaly category volume reconstructions will be compared to normal anatomy at specific gestational ages Key diagnostic findings will be documented and correlated with postnatal outcome We anticipate that our results will permit improved diagnostic interpretation of congenital defects throughout pregnancy
We are continuing to develop an image reference library of fetal anatomy by identifying key diagnostic features by three-dimensional ultrasound A cross-sectional observational study of up to 1400 fetuses will catalog a broad spectrum of congenital malformations at various gestational ages The protocol will include up to 400 examples of normal fetal anatomy by three-dimensional ultrasonography
All cases will be placed into a digital image database For each anomaly category volume reconstructions will be compared to normal anatomy at specific gestational ages Key diagnostic findings will be documented and correlated with postnatal outcome We anticipate that our results will permit improved diagnostic interpretation of congenital defects throughout pregnancy
Detailed Description:
A major goal of perinatal care is to accurately diagnose fetal anomalies prior to birth This capability allows clinicians to make prudent decisions regarding antepartum care delivery site and postnatal therapy Three-dimensional ultrasound is a recent technology that provides a new way to evaluate the fetus This technique allows one to scan through a digital ultrasound volume dataset visualize organs from different perspectives measure volumes and render anatomical features through computer processing However the accurate characterization of fetal anomalies by this technique must be interpreted in relation to normal fetal anatomy at different stages of pregnancy
We are continuing to develop an image reference library of fetal anatomy by identifying key diagnostic features by three-dimensional ultrasound A cross-sectional observational study of up to 7000 fetuses will catalog a broad spectrum of congenital malformations at various gestational ages A subset of the fetuses enrolled in this protocol will also be examined by Magnetic Resonance Imaging MRI to identify potential advantages and limitations of this imaging modality when compared to 3DUS for the diagnosis of congenital anomalies The protocol will include up to 400 examples of normal fetal anatomy by three-dimensional ultrasonography
All cases will be placed into a digital image database For each anomaly category volume data will be acquired at specific gestational ages Key diagnostic features will be documented and correlated with postnatal outcome Postnatal correlative studies may include ultrasound MRI X-ray computerized tomography CT and photography We anticipate that our results will permit improved diagnostic interpretation of congenital defects throughout pregnancy
We are continuing to develop an image reference library of fetal anatomy by identifying key diagnostic features by three-dimensional ultrasound A cross-sectional observational study of up to 7000 fetuses will catalog a broad spectrum of congenital malformations at various gestational ages A subset of the fetuses enrolled in this protocol will also be examined by Magnetic Resonance Imaging MRI to identify potential advantages and limitations of this imaging modality when compared to 3DUS for the diagnosis of congenital anomalies The protocol will include up to 400 examples of normal fetal anatomy by three-dimensional ultrasonography
All cases will be placed into a digital image database For each anomaly category volume data will be acquired at specific gestational ages Key diagnostic features will be documented and correlated with postnatal outcome Postnatal correlative studies may include ultrasound MRI X-ray computerized tomography CT and photography We anticipate that our results will permit improved diagnostic interpretation of congenital defects throughout pregnancy
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 |
|---|---|---|---|
| OH97-CH-N065 | None | None | None |