Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT00340002
Eligibility 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 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00340002
Study Brief:
Protocol Section:
NCT00340002