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Fetal Anatomy by Three-Dimensional Ultrasound
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), October 2008
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00340002
  Purpose

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 1,400 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.


Condition
Congenital Anomalies
Imaging
Prenatal Care

MedlinePlus related topics: Anatomy Prenatal Care Ultrasound
U.S. FDA Resources
Study Type: Observational
Official Title: Fetal Anatomy by Three-Dimensional Ultrasound

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 3000
Study Start Date: November 1997
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 3,000 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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

All pregnant subjects will be recruited under informed consent at either Hutzel or William Beaumont Hospitals.

The study population for both arms of this protocol will involve pregnant women greater than or equal to 15 years.

CROSS-SECTIONAL ARM OF PROTOCOL - NORMAL FETUS SUBJECTS:

3DUS STUDIES:

No fetal anomalies suspect by 2DUS.

Excellent visualization of normal fetal anatomy by 2DUS.

Accurate dating criteria by 1st trimester scam and/or menstrual history.

FETAL MRI STUDIES:

Gestational age between 18-42 menstrual weeks.

No known fetal abnormalities.

CROSS-SECTIONAL ARM OF PROTOCOL - ABNORMAL FETUSES:

3DUS STUDIES:

Congenital anomaly suspected by 2DUS.

Accurate dating criteria by 1st trimester scan and/or menstrual history.

FETAL MRI STUDIES:

Gestational age between 18-42 menstrual weeks.

Suspected fetal abnormalities.

POSTMORTEM STUDIES:

Suspected fetal abnormalities by prenatal ultrasound.

EXCLUSION CRITERIA:

CROSS-SECTIONAL ARM OF PROTOCOL - NORMAL FETUS SUBJECTS:

3DUS STUDIES:

Poor visualization of the fetus due to technical factors (e.g. obesity, surgical scar).

History of noncompliance with prenatal visits with the current or prior pregnancy.

FETAL MRI STUDIES:

Inability of the patient to fit on bore of MRI system.

Metallic implants that would increase risk to patient.

Previous occupational exposure to metal shop.

History of claustrophobia.

CROSS-SECTIONAL ARM OF PROTOCOL - ABNORMAL FETUSES:

3DUS STUDIES:

Poor visualization from technical factors (e.g. obesity or decreased amniotic fluid).

FETAL MRI STUDIES:

Inability of the patient to fit on bore of MRI system.

Metallic implants that would increase risk to patient.

Previous occupational exposure to metal shop.

History of claustrophobia.

POSTMORTEM STUDIES:

Refusal to sign informed consent for postmortem imaging studies.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00340002

Contacts
Contact: Roberto Romero, M.D. (313) 993-2700 romeror@mail.nih.gov

Locations
United States, Michigan
Hutzel Women's Hospital Recruiting
Detroit, Michigan, United States, 48201
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States
Sponsors and Collaborators
  More Information

No publications provided

Study ID Numbers: 999997065, OH97-CH-N065
Study First Received: June 19, 2006
Last Updated: November 4, 2008
ClinicalTrials.gov Identifier: NCT00340002  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Congenital Anomalies
Embryology
Imaging
Prenatal Diagnosis

Study placed in the following topic categories:
Congenital Abnormalities

ClinicalTrials.gov processed this record on February 12, 2009