The Role of Ultrasonography in Pregnancy in the Study of Fetal Central Nervous System Malformations
CNS_2021
CNS_2021
Sponsor study identifier
observational
80
1 country
1
Study Start
October 11, 2021
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The aim of this observational study is to evaluate the correlation between new ultrasound patterns and fetal central nervous system (CNS) malformations.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 11, 2021
Actual (reported)December 3, 2024
Actual (reported)January 23, 2025
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Correlation between new ultrasound patterns and fetal CNS malformations
Retrospectively analyze ultrasound images of fetuses with established brain malformations
up to 100 weeks
Comparison of ultrasound patterns found in fetuses with and without CNS malformations
up to 100 weeks
Evaluation of ultrasound images routinely performed during pregnancy in fetuses with brain malformation
Evaluation of ultrasound images routinely performed during pregnancy in healthy fetuses
Ultrasound images acquired during routine ultrasound scans performed in healthy fetuses and in fetuses found to have CNS malformations will be reviewed. Ultrasound images acquired from January 2000 to May 2021 will be analyzed until a sample size of approximately 80 patients is reached, who will be divided into 2 groups: group A (patients whose fetus has CNS malformations) and group B (healthy patients whose fetus has no anatomical CNS abnormalities).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Participants will be divided into 2 groups: group A (patients whose fetus has central nervous system malformations) and group B (healthy patients whose fetus has no anatomical abnormalities of the central nervous system).
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138, Italy
Gianluigi Pilu, MD
IRCCS Azienda Ospedaliero-Universitaria di Bologna
First Submitted
December 3, 2024
First Posted
January 23, 2025
Study Start
October 11, 2021
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 30, 2025
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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