Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000330943
Ethics application status
Approved
Date submitted
18/03/2011
Date registered
29/03/2011
Date last updated
29/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Neuromotor assessment in patients with myelomeningocele submitted to intrauterine surgery
Scientific title
Neuromotor assessment in patients with myelomeningocele submitted to intrauterine surgery
Secondary ID [1] 259813 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal malformation 265395 0
Condition category
Condition code
Physical Medicine / Rehabilitation 265549 265549 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational Study
Period: four years
It was observed neuromotor development in patientes that submitted to inrtauterine surgery by Hoffer Classification. It was analyzed the cognitive level by Columbia Mental Scale and the socioeconomic level by Brazilian Economic Classification Test.
Intervention code [1] 264243 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262357 0
The results showed that six cases(100%) that underwent intrauterine surgical repair demonstrated better functional motor development in relation to the anatomic lesion by Hoffer Classification.
Timepoint [1] 262357 0
In three years after born
Secondary outcome [1] 273622 0
Only two patients (33,33%) that underwent intrauterine surgery developed hydrocephalia. It was observed by ressonance magnetic test.
Timepoint [1] 273622 0
In one month after birth

Eligibility
Key inclusion criteria
Patients with clinical diagnosis of myelomeningocele
Patients submitted to intrauterine surgery
Children born by cesarean section
Minimum age
3 Years
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with myelomeningocele no submitted to intrauterine surgery

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 3304 0
Brazil
State/province [1] 3304 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 264695 0
University
Name [1] 264695 0
Federal University of Sao Paulo
Country [1] 264695 0
Brazil
Primary sponsor type
University
Name
Federal University of Sao Paulo
Address
Napoleao de Barro, 715 6 andar
Vila Clementino
Sao Paulo
Zip code 04039900
Country
Brazil
Secondary sponsor category [1] 263827 0
None
Name [1] 263827 0
Address [1] 263827 0
Country [1] 263827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266686 0
Committee Ethic of Federal University of Sao Paulo
Ethics committee address [1] 266686 0
Ethics committee country [1] 266686 0
Brazil
Date submitted for ethics approval [1] 266686 0
Approval date [1] 266686 0
03/04/2006
Ethics approval number [1] 266686 0
1/04/0864

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32359 0
Address 32359 0
Country 32359 0
Phone 32359 0
Fax 32359 0
Email 32359 0
Contact person for public queries
Name 15606 0
Tereza Cristina Carbonari de Faria
Address 15606 0
Adolfo Figueiredo Rodrigues, 682 Mogi das Cruzes SP zip code 08770555
Country 15606 0
Brazil
Phone 15606 0
55 11 47901747
Fax 15606 0
55 11 4790 1747
Email 15606 0
[email protected]
Contact person for scientific queries
Name 6534 0
Tereza Cristina Carbonari de Faria
Address 6534 0
Adolfo Figueiredo Rodrigues, 682 Mogi das Cruzes SP zip code 08770555
Country 6534 0
Brazil
Phone 6534 0
55 11 4790 1747
Fax 6534 0
55 11 4790 1747
Email 6534 0
[email protected]

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.