Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001005246
Ethics application status
Approved
Date submitted
10/10/2009
Date registered
20/11/2009
Date last updated
20/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of pelvic floor muscle training in pregnant women
Scientific title
Effects of pelvic floor muscle training on pelvic floor muscle function in women during their first pregnancies measured by perineometer.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
healthy pregnant women 243893 0
pelvic floor muscle function 252060 0
Condition category
Condition code
Physical Medicine / Rehabilitation 252068 252068 0 0
Physiotherapy
Renal and Urogenital 252263 252263 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
pelvic floor muscle training in healthy pregnant women in four different positions during 16 weeks/sessions (the sessions duration was 30 minutes, once a week), beginning at 20 th week of gestation, one-on-one training with a physiotherapist to analyze the effect during the pregnancyand post partum. Pelvic floor muscle training is a training for the pelvic floor muscle to improve the strength and the function of these muscles thet support the abdominal organs and realize the continence (fecal and urinary)
Intervention code [1] 241322 0
Prevention
Comparator / control treatment
the same number of healthy pregnant women who do not practice the pelvic floor training during this period
Control group
Active

Outcomes
Primary outcome [1] 252962 0
pelvic floor muscle function of evaluated by perineometry and digital palpation
Timepoint [1] 252962 0
20 weeks of pregnancy
Primary outcome [2] 253128 0
pelvic floor muscle function during pregnancy and after delivery
Timepoint [2] 253128 0
24th and 36th week of pregnancy and 6 weeks after delivery
Secondary outcome [1] 257700 0
self-related-incontinence asking if she lose urine in the last month by interview with participant
Timepoint [1] 257700 0
36th week of pregnancy and 6 weeks after delivery

Eligibility
Key inclusion criteria
woman in the first pregnancy, without complications and who can contract correctly the pelvic floor
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
complications during the pregnancy

Study design
Purpose of the study
Prevention
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 2149 0
Brazil
State/province [1] 2149 0
SP

Funding & Sponsors
Funding source category [1] 243858 0
Self funded/Unfunded
Name [1] 243858 0
Daniella Leiros Cunha Cavalcanti
Country [1] 243858 0
Brazil
Primary sponsor type
Individual
Name
Daniella Leiros Cunha Cavalcanti
Address
Rua Arnaldo Victaliano, 881 bl5 ap 31A
CEP 14091-220 Ribeirao Preto/SP
Country
Brazil
Secondary sponsor category [1] 237207 0
Charities/Societies/Foundations
Name [1] 237207 0
Fundacao e Amparo a Pesquisa do Estado de Sao Paulo
Address [1] 237207 0
R. Pio XI, 1500 - Alto da Lapa - CEP 05468-901 - Sao Paulo/SP
Country [1] 237207 0
Brazil
Other collaborator category [1] 889 0
Hospital
Name [1] 889 0
Faculdade de Medicina de Ribeirao Preto
Address [1] 889 0
Av. Bandeirantes, 3900 - Monte Alegre - CEP: 14049-900 Ribeirao Preto/SP
Country [1] 889 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243981 0
Comissao de Etica e Pesquisa da Faculdade de Medicina de Ribeirao Preto Universidade de Sao Paulo
Ethics committee address [1] 243981 0
Ethics committee country [1] 243981 0
Brazil
Date submitted for ethics approval [1] 243981 0
Approval date [1] 243981 0
Ethics approval number [1] 243981 0
13756-2006

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

Contacts
Principal investigator
Name 30316 0
Address 30316 0
Country 30316 0
Phone 30316 0
Fax 30316 0
Email 30316 0
Contact person for public queries
Name 13563 0
Daniella Leiros Cunha Cavalcanti
Address 13563 0
Rua Arnaldo Victaliano, 881 bl5 ap 31A CEp 14091-220 Ribeirão Preto/SP
Country 13563 0
Brazil
Phone 13563 0
55 16 9177-4433
Fax 13563 0
Email 13563 0
[email protected]
Contact person for scientific queries
Name 4491 0
Cristine Homsi Jorge Ferreira
Address 4491 0
Av. Bandeirantes, 3900 - Monte Alegre - CEP: 14049-900 Ribeirão Preto/SP
Country 4491 0
Brazil
Phone 4491 0
55 16 3206-3058
Fax 4491 0
Email 4491 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.