Status:
COMPLETED
Fetal Anatomy by Three-Dimensional Ultrasound
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Preterm Birth
Pregnancy
Eligibility:
FEMALE
18+ years
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 postn...
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 postn...
Eligibility Criteria
Inclusion
- 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 suspected by 2DUS.
- Excellent visualization of normal fetal anatomy by 2DUS.
- Accurate dating criteria by 1st trimester scan 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 in 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 fetal visualization from technical factors (e.g. obesity or decreased amniotic fluid).
- FETAL MRI STUDIES:
- Inability of the patient to fit in 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.
Exclusion
Key Trial Info
Start Date :
November 26 1997
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 18 2016
Estimated Enrollment :
3650 Patients enrolled
Trial Details
Trial ID
NCT00340002
Start Date
November 26 1997
End Date
November 18 2016
Last Update
February 24 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hutzel Women's Hospital
Detroit, Michigan, United States, 48201
2
William Beaumont Hospital
Royal Oak, Michigan, United States