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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.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-6c3bvm
Date of registration: 01/09/2011
Primary sponsor: Faculdade de Medicina de Ribeirão Preto - Brazil
Public title: Physical therapy protocol on normal birth puerperium
Scientific title: Physical therapy protocol on normal birth puerperium
Date of first enrolment: 01/08/2011
Target sample size: 80
Recruitment status: not yet recruiting
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-6c3bvm/
Study type: 
Study design:  Clinical trial, randomized controlled of prevention with two parallel arms, masking single blinded .  
Countries of recruitment
Brazil
Contacts
Name: Daniella  Aita
Address:  Av. Bandeirantes, 3900 - Monte Alegre 14049-900 Ribeirão Preto/SP Brazil
Telephone: 3446-4433
Email: daniellaleiros@usp.br
Affiliation:  FMRP
Name: Daniella  Aita
Address:  Av. Bandeirantes, 3900 - Monte Alegre 14049-900 Ribeirão Preto/SP Brazil
Telephone: 3446-4433
Email: daniellaleiros@usp.br
Affiliation:  FMRP
Key inclusion & exclusion criteria
Inclusion criteria: Being resident in the city of Ribeirao Preto, housewife for at least six months, being between 20 and 35 years old, weight between 60 and 70 pounds in the puerperium, height between 146 and 160 centimeters, having had an adequate weight gain during pregnancy (7 to 12 pounds), primigravida, vaginal delivery without episiotomy with laceration until 1 degree, having at least 6 hours after delivery and a maximum of 24 hours on the first visit, present abdominal diastasis larger than 2 centimeters (in caliper) and want to participate in the research
Exclusion criteria: Perineal laceration greater than or equal to grade 2, forceps delivery, episiotomy, cesarean birth, abdominal diastasis under two centimeters or any pathology that would contraindicate a physical exercise


Age minimum: 20Y
Age maximum: 35Y
Gender: F
Health Condition(s) or Problem(s) studied
O00-O99
Primiparous immediately post vaginal delivery
G08.686.702
Z00-Z99
Intervention(s)
The study will be of an experimental nature, where 80 volunteers will be allocated into two groups, group activity (GA) and control group (CG). The group activity will be subject to application of a protocol of physiotherapy during the postpartum period. The protocol consists of breathing exercises, circulatory, abdominal, pelvic floor, stretching, abdominal massage, posture and walking directions. During the immediate postpartum period (first 10 days) the protocol will be conducted in individual sessions and supervised the volunteers daily at home. From the eleventh day after delivery, the protocol will be applied in supervised group sessions once a week at the Reference Center on Women's Health in Ribeirão Preto after meetings of the group of mothers that occurs daily. The protocol is adapted according to the recovery phase of post-partum. The subjects in the control group will not be met following the exercise protocol, but will be guided, informed and followed the same way that the Group Activity.
Primary Outcome(s)
Measure: centimeters (abdominal diastasis postpartum by perineometer)
Pparameter used: ideal measure less than 2 centimeters
Secondary Outcome(s)
As secondary aim: to find reliability and trustworthiness of the caliper (according to the examination of the gold standard - musculoskeletal ultrasound) measured in centimeters; increase in body satisfaction scores in the postpartum period (scores from 1 to 5 on Body Satisfaction Situational Scale, adapted from Hirata and Pilati, 2010); increase in scores related to "positive affect" and "life satisfaction" and reduction of scores related to "negative affect" and "dissatisfaction with life" in relation to psychological well-being of postpartum women (scores from 1 to 5 on Scale of Subjective Well-Being and Trocoli Albuquerque, 2004), reduction in signs of postpartum depression (maximum score of 30 on the Edinburgh Postnatal Depression Scale from Santos et al., 2007) reduction to below 13 points, find related improvement in body satisfaction (score increases), the psychological well-being (increase and / or reduction of scores) and reducing the signs of postpartum depression (reduction of score) with the practice of physical exercise; finding regarding the presence of bodily discomfort (sum of sites according to the map of the body segments of discomfort Corlett and Bishop, 1976) with non-postpartum exercises, find greater reduction abdominal diastasis (cm), greater psychological well-being (score of 1 to 5) and greater body satisfaction (score of 1 to 5) in the immediate postpartum period (exercises daily).
Secondary ID(s)
10472/2008
U1111-1122-6599
Source(s) of Monetary Support
Faculdade de Medicina de Ribeirão Preto - Brazil
Secondary Sponsor(s)
Faculdade de Medicina de Ribeirão Preto - Brazil
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