Condition: Episiotomy · Lacerations Perineal · Obstetric Anal Sphincter Injury · Sponsor: University of Sao Paulo
The aim of this study is to assess the effectiveness of a pelvic floor muscle training (PFMT) protocol associated with cryotherapy initiated in the immediate postpartum period in relieving pain in primiparous women who suffered perineal trauma during vaginal delivery. This is a hybrid effectiveness-implementation type 1 randomized controlled trial with economic evaluation, which will include 82 primiparous women who suffered a perineal tear of grade 2 or above or episiotomy during vaginal delivery. The study participants will be selected from among the women who gave birth at the Hospital das Clínicas in Ribeirão Preto and will be randomly assigned to participate in one of two study groups: the Control Group will receive the usual maternity care, that includes suturing the injury and analgesic medication, and the Intervention Group will receive the usual care combined with a physiotherapy protocol of PFMT and cryotherapy, starting in the immediate postpartum period and lasting 3 months. The primary outcome of the study will be the change in perineal pain intensity assessed using an 11-point Numerical Rating Scale; and the secondary outcomes will be self-reported pelvic floor dysfunction, recovery from injury, functionality, health-related quality of life, use of pain medication, genital self-image and implementation outcomes (satisfaction, acceptability, adequacy, feasibility, equity and adherence to the protocol). Assessments will be carried out by a group of health professi…
This description comes directly from the study's public registry record.
Caroline Soares de Paula · +55 19 996307633 · carolinesoarespaula@gmail.com
Cristine Homsi Jorge · +55 16 996217919 · cristine@fmrp.usp.br
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| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | Ribeirão Preto, São Paulo, Brazil | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07170007