Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001364763
Ethics application status
Approved
Date submitted
1/12/2013
Date registered
13/12/2013
Date last updated
13/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The comparison of the imaging with 2D, 3D and 4D Volume Contrast Imaging in Plane C (VCI-C) ultrasound methods for the fetal brain structures
Scientific title
The comparison of the imaging with 2D, 3D and 4D Volume Contrast Imaging in Plane C (VCI-C) ultrasound methods for the fetal midbrain and posterior fossa structures in healthy pregnant women.
Secondary ID [1] 283664 0
'nil'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetal cranial structures 290618 0
Condition category
Condition code
Reproductive Health and Childbirth 291009 291009 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The evaluation of fetal midbrain and posterior fossa stuctures with ultrasound after their second trimester fetal anatomic survey is done. The ultrasound evaluation will be done using 2D, 3D and 4D modalities. Fetal intracranial structures(midbrain and posterior fossa structures) will be the point of interest. It will be done only once and will take approximately 20 min.The 3D and 4D VCI-C ultrasound methods are the intervention methods studied in this trial. 3D is a record of the image in three dimensions whereas 4D VCI-C is a real time evaluation of these dimensions.
Intervention code [1] 288364 0
Other interventions
Intervention code [2] 288458 0
Diagnosis / Prognosis
Comparator / control treatment
The comparison is made between 2D, 3D and 4D VCI-C ultrasound methods.2D evaluation will be the control. It will be done only once and will take approximately 20 min.
Control group
Active

Outcomes
Primary outcome [1] 290991 0
Comparison of the results of 3D and 4D with 2D in the visualization,length and the thickness of corpus callosum, calculations of brainstem-tentorium angle and brainstem-vermis angle and visualization of primary and secondary cerebellar fissures and visualization and length of cerebellar vermis. The results will be compared with parametric and nonparametric statistical tests. Composite outcome.
Timepoint [1] 290991 0
Assessed at 18 months from baseline
Secondary outcome [1] 305761 0
Comparison of the results of 3D and 4D with 2D for the differences in the results with fetal presentation, gestational age, maternal body mass index and previous number of ceserean sectionsThe results will be compared with parametric and nonparametric statistical tests. Composite outcome.
Timepoint [1] 305761 0
Assessed at 18 months from baseline

Eligibility
Key inclusion criteria
Patients whose fetal anatomic survey with ultrasound revealed no anatomic anomaly
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
fetal anomaly( structural or genetic)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Sample size was determined from previous studies.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/12/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 5658 0
Turkey
State/province [1] 5658 0

Funding & Sponsors
Funding source category [1] 288353 0
Self funded/Unfunded
Name [1] 288353 0
Country [1] 288353 0
Primary sponsor type
Individual
Name
cihan cetin
Address
Cukurova University School of Medicine Department of Obstetrics and Gynecology, Division of Perinatology, 01330 Adana
Country
Turkey
Secondary sponsor category [1] 287061 0
None
Name [1] 287061 0
Address [1] 287061 0
Country [1] 287061 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The comparison of the imaging with 2D, 3D and 4D VCI-C ultrasound methods for the fetal midbrain and posterior fossa structures. These structures include corpus callosum, brainstem-tentorium angle, brainstem-vermis angle, cerebellar fissures and vermis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44610 0
Dr Cihan Cetin
Address 44610 0
Cukurova University School of Medicine Department of Obstetrics and Gynecology, Division of Perinatology, 01330 Adana
Country 44610 0
Turkey
Phone 44610 0
+905332241033
Fax 44610 0
Email 44610 0
cihancetin00@yahoo.com
Contact person for public queries
Name 44611 0
Dr Cihan Cetin
Address 44611 0
Cukurova University School of Medicine Department of Obstetrics and Gynecology, Division of Perinatology, 01330 Adana
Country 44611 0
Turkey
Phone 44611 0
+905332241033
Fax 44611 0
Email 44611 0
cihancetin00@yahoo.com
Contact person for scientific queries
Name 44612 0
Dr Cihan Cetin
Address 44612 0
Cukurova University School of Medicine Department of Obstetrics and Gynecology, Division of Perinatology, 01330 Adana
Country 44612 0
Turkey
Phone 44612 0
+905332241033
Fax 44612 0
Email 44612 0
cihancetin00@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.