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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-53wq87 |
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Date of registration:
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26/01/2012 |
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Primary sponsor: |
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Public title:
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Orientation of perineal exercises during postpartum to prevent urinary loss
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Scientific title:
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Study about the influence of pelvic floor exercises orientation regarding urinary loss prevention on postpartum period |
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Date of first enrolment:
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15/09/2011 |
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Target sample size:
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300 |
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Recruitment status: |
recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-53wq87/ |
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Study type:
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Study design:
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Clinical trial, randomized controlled, parallel, two arms, open.
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Cinara
Sacomori |
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Address:
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Rua Pascoal Simone, 358, Coqueiros
88080-350
Florianópolis
Brazil |
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Telephone:
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4899688381 |
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Email:
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csacomori@yahoo.com.br |
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Affiliation:
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Universidade do Estado de Santa Catarina |
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Name:
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Fabiana
Sperandio |
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Address:
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Rua Pascoal Simone, 358, Coqueiros
88080-350
Florianópolis
Brazil |
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Telephone:
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4899710572 |
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Email:
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fabi@intercorp.com.br |
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Affiliation:
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Universidade do Estado de Santa Catarina |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women that had a vaginal or cesarean delivery during the study period on Maternidade Carmela Dutra, Florianópolis, SC
Exclusion criteria: Postpartum women that present the following conditions:
- neurologic urinary incontinence
- history of urogenital cancer
- cognitive deficit
- diagnosed neurological diseases
- blindness
- illiterate
- younger than 18 years old
- episiotomy associated with local conditions (important edema and excessive pain)
- drug dependents
- those that do not have a telephone for further contact.
Age minimum:
18Y
Age maximum:
45Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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Self-report of urinary loss, constipation, dyspareunia, female urogenital diseases and pregnancy complications, urinary incontinence C12.777.934.852 C12.294.644.242 C23.888.821.150
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Intervention(s)
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Intervention includes pelvic floor exercise orientation throughout observation. The last one is to verify if the woman is correctly contracting her pelvic floor. In the next step domiciliary pelvic floor muscle exercises will be prescribed according to an adapted protocol of Reilly et al (2002): Practice twice a day the following exercises repeating at least 10 times: - One sustained contraction up to 10 seconds (tonic fibers). Pedagogical analogy: "elevator exercise". - Five quick and strong contractions. Pedagogical analogy: like the rhythm of a baby breastfeeding. - Use the Knack. After this intervention the patients will receive a folder with information about the prescribed exercises, urinary habits and how to prevent constipation.
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Primary Outcome(s)
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The ammount of urinary loss: none, a small, moderate or large quantities. Also evaluated using the International Consultation on Incontinence Questionnaire Short Form.
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The primary outcome will be the frequency of urinary loss: frequent urinary loss episodes, not many urinary loss episodes and no urinary loss. The instrument is the International Consultation on Incontinence Questionnaire Short Form.
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Secondary Outcome(s)
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Constipation considered when there is less than three evacuations per week.
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Frequency of Dyspareunia: always, most times, sometimes, a few times, never. Assessed with the Female Sexual Function Index.
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Intensity of dyspareunia: very high, moderate, low, none. Assessed with the Female Sexual Function Index.
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Secondary ID(s)
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0010.0.233.269-11
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Source(s) of Monetary Support
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Universidade do Estado de Santa Catarina - Brazil
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