Clinical Trials Logo

Clinical Trial 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 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.


Clinical Trial 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 7,000 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00340002
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase
Start date November 26, 1997
Completion date November 18, 2016

See also
  Status Clinical Trial Phase
Completed NCT03442582 - Afluria Pregnancy Registry
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04548102 - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman N/A
Completed NCT03218956 - Protein Requirement During Lactation N/A
Completed NCT02191605 - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy N/A
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting NCT06049953 - Maternal And Infant Antipsychotic Study
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting NCT05412238 - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months N/A
Not yet recruiting NCT05028387 - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed NCT02783170 - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women Phase 4
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting NCT02619188 - Nutritional Markers in Normal and Hyperemesis Pregnancies N/A
Recruiting NCT02564250 - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women N/A
Completed NCT02379728 - Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth N/A