The Role of Ultrasonography in Pregnancy in the Study of Fetal Central Nervous System Malformations

NCT06788808 | Recruiting

• 1 other identifier: CNS_2021
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to evaluate the correlation between new ultrasound patterns and fetal central nervous system (CNS) malformations.

Conditions

Malformation Brain

Keywords

Prenatal ultrasounds

Outcome Measures

Primary Outcomes (1)

• Correlation between new ultrasound patterns and fetal CNS malformations

  Retrospectively analyze ultrasound images of fetuses with established brain malformations

  up to 100 weeks

Secondary Outcomes (1)

• Comparison of ultrasound patterns found in fetuses with and without CNS malformations

  up to 100 weeks

Study Arms (2)

Fetus with CNS malformations

Evaluation of ultrasound images routinely performed during pregnancy in fetuses with brain malformation

Other: Comparison between groups

Fetus withous CNS malformations

Evaluation of ultrasound images routinely performed during pregnancy in healthy fetuses

Other: Comparison between groups

Interventions

Comparison between groups OTHER

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).

Fetus with CNS malformations; Fetus withous CNS malformations

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• Women older than 18 years with single pregnancy and fetus with ultrasound diagnosis of central nervous system malformation (group A)
• Women with single pregnancy and normoconformed fetuses (group B).

You may not qualify if:

• Twin pregnancy

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Study Officials

• Gianluigi Pilu, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluigi Pilu, MD

CONTACT

0512143493; gianluigi.pilu@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 23, 2025
• Study Start: October 11, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 30, 2025

Record last verified: 2024-10

Locations

IT (1)