CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,650 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT00340002
NCT00340002N/ACompleted

Fetal Anatomy by Three-Dimensional Ultrasound

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·observational·Posted Jun 21, 2006·Updated Feb 24, 2023

In Brief

An observational study for Preterm Birth and 2 related conditions. Completed, enrolled 3,650 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 21, 2006
Enrollment StartNov 26, 1997
Primary CompletionNov 18, 2016
TodayJul 2, 2026
Enrollment to primary: 19.0 yearsPosted 20.0 years ago