Malformation BrainCNS_2021NCT06788808
The Role of Ultrasonography in Pregnancy in the Study of Fetal Central Nervous System Malformations
An observational study of Malformation Brain, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The aim of this observational study is to evaluate the correlation between new ultrasound patterns and fetal central nervous system (CNS) malformations. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Malformation Brain
- What is being tested?
- Comparison between groups
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 11 Oct 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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).
Who may be able to join
- 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).
Who cannot join
- Twin pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Gianluigi Pilu, MD, 0512143493, gianluigi.pilu@aosp.bo.it
About this study
The aim of this observational study is to evaluate the correlation between new ultrasound patterns and fetal central nervous system (CNS) malformations.
Read the detailed description
During fetal life, the CNS undergoes major changes, so it is important to study the evolution of brain morphology serially during intrauterine life.
Despite numerous data in the literature, prenatal ultrasound diagnosis of CNS malformations is often difficult due to the presence of imaging pictures that are nondiagnostic or difficult to interpret. Moreover, only some of the sonographic features of CNS malformations have been described in detail. Therefore, it is essential to study and describe the ultrasound pictures in order to identify new ultrasound patterns useful to identify the fetal malformation more clearly. Therefore, this study aims to retrospectively analyze the ultrasound images of fetuses with established brain malformations and compare them with those of healthy fetuses in order to highlight the presence of new ultrasound patterns, which may more clearly define the malformative pathology.
Ultrasound images routinely performed in pregnancy in fetuses with brain malformation and in healthy fetuses will be reviewed.
For each patient, information will be collected on:
- Age
- Previous pregnancies and their outcome
- Pregnancy arising spontaneously or through Medically Assisted Procreation techniques
- Family history of congenital malformation
- Type of central nervous system malformation (neural tube defects, holoprosencephaly, corpus callosum agenesis, cerebellar malformations, posterior cranial fossa cysts, other malformations)
- Gestational age at the time of diagnostic suspicion
- Gestational epoch at the time of diagnosis
- Pregnancy outcome (miscarriage, voluntary termination of pregnancy, spontaneous delivery or cesarean section)
- Presence of associated abnormalities affecting other anatomical districts
For each newborn, information will be collected on:
- Sex
- Weight
- Umbilical artery pH
- APGAR index at 5 and 10 minutes
- Neurological assessment in the immediate postpartum period
- Perinatal mortality
- Conditions
- Malformation Brain
- Being tested
- Comparison between groups
- Keywords
- Prenatal ultrasounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison between groupsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Fetus with CNS malformations | Evaluation of ultrasound images routinely performed during pregnancy in fetuses with brain malformation Receives: Other: Comparison between groups | |
| Fetus withous CNS malformations | Evaluation of ultrasound images routinely performed during pregnancy in healthy fetuses Receives: Other: Comparison between groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between new ultrasound patterns and fetal CNS malformations
Retrospectively analyze ultrasound images of fetuses with established brain malformations
Measured: up to 100 weeks
Secondary outcomes (1)
Comparison of ultrasound patterns found in fetuses with and without CNS malformations
Comparison of ultrasound scans of fetuses with and without CNS malformation to discover of new ultrasound patterns, which may more clearly define the malformative pathology.
Measured: up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start11 Oct 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malformation BrainStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianluigi Pilu, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788808
- Sponsor's protocol ID
- CNS_2021
- Acronym
- CNS_2021
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ultrasonography in Pregnancy in the Study of Fetal Central Nervous System Malformations
- ClinicalTrials.gov ID
- NCT06788808
- Acronym / sponsor ID
- CNS_2021 / CNS_2021
- Conditions
- Malformation Brain
- Keywords
- Prenatal ultrasounds
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this observational study is to evaluate the correlation between new ultrasound patterns and fetal central nervous system (CNS) malformations.
Detailed description
During fetal life, the CNS undergoes major changes, so it is important to study the evolution of brain morphology serially during intrauterine life.
Despite numerous data in the literature, prenatal ultrasound diagnosis of CNS malformations is often difficult due to the presence of imaging pictures that are nondiagnostic or difficult to interpret. Moreover, only some of the sonographic features of CNS malformations have been described in detail. Therefore, it is essential to study and describe the ultrasound pictures in order to identify new ultrasound patterns useful to identify the fetal malformation more clearly. Therefore, this study aims to retrospectively analyze the ultrasound images of fetuses with established brain malformations and compare them with those of healthy fetuses in order to highlight the presence of new ultrasound patterns, which may more clearly define the malformative pathology.
Ultrasound images routinely performed in pregnancy in fetuses with brain malformation and in healthy fetuses will be reviewed.
For each patient, information will be collected on:
- Age
- Previous pregnancies and their outcome
- Pregnancy arising spontaneously or through Medically Assisted Procreation techniques
- Family history of congenital malformation
- Type of central nervous system malformation (neural tube defects, holoprosencephaly, corpus callosum agenesis, cerebellar malformations, posterior cranial fossa cysts, other malformations)
- Gestational age at the time of diagnostic suspicion
- Gestational epoch at the time of diagnosis
- Pregnancy outcome (miscarriage, voluntary termination of pregnancy, spontaneous delivery or cesarean section)
- Presence of associated abnormalities affecting other anatomical districts
For each newborn, information will be collected on:
- Sex
- Weight
- Umbilical artery pH
- APGAR index at 5 and 10 minutes
- Neurological assessment in the immediate postpartum period
- Perinatal mortality
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fetus with CNS malformations | – | Other: Comparison between groupsEvaluation of ultrasound images routinely performed during pregnancy in fetuses with brain malformation |
| Fetus withous CNS malformations | – | Other: Comparison between groupsEvaluation of ultrasound images routinely performed during pregnancy in healthy fetuses |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Twin pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison between groupsUltrasound 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). | Other | Fetus with CNS malformations, Fetus withous CNS malformations |
Primary outcome
Correlation between new ultrasound patterns and fetal CNS malformations
Time frame: up to 100 weeks
Retrospectively analyze ultrasound images of fetuses with established brain malformations
1 secondary outcome
Comparison of ultrasound patterns found in fetuses with and without CNS malformations
Time frame: up to 100 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gianluigi Pilu, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malformation Brain, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianluigi Pilu, MD (0512143493, gianluigi.pilu@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between new ultrasound patterns and fetal CNS malformations (time frame: up to 100 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.