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Trial registered on ANZCTR


Registration number
ACTRN12609001083280
Ethics application status
Approved
Date submitted
15/12/2009
Date registered
18/12/2009
Date last updated
3/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of muscle strength and perinatal and maternal effects resulting from the strengthening exercises of the pelvic floor in pregnancy
Scientific title
Assessment and training of the pelvic floor muscles in low-risk pregnant and with gestational diabetes mellitus
Secondary ID [1] 1208 0
None
Universal Trial Number (UTN)
U1111-1112-9030
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The effect of pelvic floor muscles strength in healthy pregnancy volunteers 252390 0
The effect of pelvic floor muscles strength in gestacional diabetes mellitus volunteers 252391 0
Condition category
Condition code
Reproductive Health and Childbirth 256572 256572 0 0
Normal pregnancy
Reproductive Health and Childbirth 256573 256573 0 0
Fetal medicine and complications of pregnancy
Physical Medicine / Rehabilitation 256591 256591 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Participants of the training group will participate in individual weekly 20 minutes sessions of pelvic flor muscle training (PFMT) supervise by two physiotherapists with the same background during 12 or 17 weeks. The number of sessions during pregnany will be determined according to the gestational age at which it is in the first evaluation
Intervention code [1] 255694 0
Prevention
Intervention code [2] 255711 0
Rehabilitation
Comparator / control treatment
The participants of the control group will be evaluated at 20, 25 and 36 weeks of gestational age and 6 weeks after the labor. The volunters in the control group do not training the pelvic floor muscles weekly.
Control group
Active

Outcomes
Primary outcome [1] 257463 0
Evaluate the efficiency of the pelvic floor muscle training on reducing clinical signs of urinary incontinence by validated questionaries.
Timepoint [1] 257463 0
The questionaries will be aplicated with 20, 25, 28 and 36 weeks of gestational age and 6 weeks after labor
Primary outcome [2] 257464 0
Assess the impact of the pelvic floor muscle training on electromyographic activity using a eletromyograph device and on a pelvic floor muscle strenght assessed by a perineometer.
Timepoint [2] 257464 0
The assessment with the eletromyograpy and perineometer devices will be done with 20, 25 and 36 of gestational age and with 6 weeks after the labor.
Secondary outcome [1] 262637 0
Assess the rates of urinary incontinence during pregnancy and the postpartum period by a validaded questionnaire.
Timepoint [1] 262637 0
The questionaries will be aplicated with 25, 28 and 36 weeks of gestational age and 6 weeks after labor
Secondary outcome [2] 262638 0
Glucose levels before and after exercise of contraction of the pelvic floor muscles by a glucometer.
Timepoint [2] 262638 0
The analyses of the glucose levels will be done in each session of supervised training getting a total of 12 measures
Secondary outcome [3] 262639 0
Hemodynamic responses maternal and fetal resulting from implementation of the contraction of the pelvic floor muscles evaluating the blood pressure, temperature, heart rate maternal and the fetal condition by ultrasound examinations during the exercise
Timepoint [3] 262639 0
The maternal responses will be evaluated in each supervised pelvic floor training and the ultrasound examinations will be done with the participants with 20, 25, 28, 32 and 36 weeks of gestational age
Secondary outcome [4] 262640 0
The impact of the exercise of contraction of the pelvic floor in relation to variables related to childbirth and the newborn. The medical records will be assessed after labor to collected this data and a blinded assessor will be collected this.
Timepoint [4] 262640 0
The assessement of the medical records will be done at new labor.
Secondary outcome [5] 262641 0
Histomorphometric features of the levator ani muscle in postpartum women who were treated or not a program to strengthen the pelvic floor muscles during pregnancy. The women who will have a vaginal delivery with episiotomy will have a sample of the pelvic floor muscle collected and this sample will be analyzed histologically.
Timepoint [5] 262641 0
The collect of the sample of the pelvic floor muscle will be done during the labor.
Secondary outcome [6] 262644 0
The quality of life of pregnant women of control or training group will be evaluated by a validade questionnarie.
Timepoint [6] 262644 0
The assessment of the quality of life will be done with the participants with 25, 28 and 36 weeks of gestational age and 6 weeks after labor.
Secondary outcome [7] 262664 0
Heart rate, blood pressure and temperature through the implementation of PFMT will be evaluated with especifics equipaments like a frequencimeter, sphygmomanometer and thermometer.
Timepoint [7] 262664 0
These measures will be implemented in all supervisioned pelvic floor muscle training (once a week) with a total of 12 or 17 measures
Secondary outcome [8] 262665 0
The sexual functions between the participants of training or control group will be assessed by a validaded questionnarie.
Timepoint [8] 262665 0
The application of the questionnaires will be held with 25, 28 and 36 of gestational age and 6 weeks after labor

Eligibility
Key inclusion criteria
Will be included in the study low risk pregnant women with gestational diabetes and pregnant women under 20 weeks of gestational age using the following criteria: nulliparity, older than 18 years of age, pregnancy topical single fetus, no own disease or concomitant with pregnancy against -recommend exercise or limit the physical exercise
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Be excluded from the study women who perform regular exercise considering the following criteria: frequency of twice a week lasted more than thirty minutes. Will be excluded also those who do not submit proper adherence to the regime of physical activity or to planned visits, the development of diseases that contraindicate or limit the exercise, intolerance and perineometer use of allergy to latex condoms.

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)
with the volunteers with 20 or 25 weeks of gestation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
It generated a sequence of random numbers by a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2366 0
Brazil
State/province [1] 2366 0
Sao Paulo/Ribeirao Preto

Funding & Sponsors
Funding source category [1] 256178 0
Charities/Societies/Foundations
Name [1] 256178 0
Foundation of Research State of Sao Paulo
Country [1] 256178 0
Brazil
Primary sponsor type
Charities/Societies/Foundations
Name
Foundation of Research State of Sao Paulo
Address
Pio XI Street, 1500 - Alto da Lapa - Zip code 05468-901 - Sao Paulo/SP
Country
Brazil
Secondary sponsor category [1] 251517 0
None
Name [1] 251517 0
Address [1] 251517 0
Country [1] 251517 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258281 0
Ethics Committee of the Hospital das Clinicas, Faculty of Medicine of Ribeirao Preto, University of Sao Paulo
Ethics committee address [1] 258281 0
Ethics committee country [1] 258281 0
Brazil
Date submitted for ethics approval [1] 258281 0
Approval date [1] 258281 0
04/12/2006
Ethics approval number [1] 258281 0
9528/2006

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

Contacts
Principal investigator
Name 30616 0
Address 30616 0
Country 30616 0
Phone 30616 0
Fax 30616 0
Email 30616 0
Contact person for public queries
Name 13863 0
Cristine Homsi Jorge Ferreira
Address 13863 0
Paineiras Street, House 2, Monte Alegre. Zip code: 14.049-900, Ribeirao Preto – Sao Paulo, Brasil.
Country 13863 0
Brazil
Phone 13863 0
+55 16 3602 3058
Fax 13863 0
Email 13863 0
cristine@fmrp.usp.br
Contact person for scientific queries
Name 4791 0
Leticia Alves Rios Dias
Address 4791 0
Campos Salles Street, 183, Ap 143, Centro, Zip code: 14015-110. Ribeirao Preto-SP
Country 4791 0
Brazil
Phone 4791 0
+55 16 3877 1725
Fax 4791 0
Email 4791 0
le.rios@uol.com.br

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

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