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Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma

RecruitingNAAges 18 Years - anyFemaleUniversity of Sao Paulo
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In plain words

What the trial is, and whether it could suit you

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 physiotherap

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📋 Eligibility rules (as published)
Inclusion Criteria: * The study will include female at birth aged 18 years or older, primiparous (no previous pregnancy after 16 weeks), who have suffered a perineal laceration of grade ≥2 or episiotomy, with ≥37 weeks of gestation at the time of delivery, who have not used testosterone in the last 6 months, with preserved cognitive ability, no history of neurological diseases, no symptoms of vaginal or urinary tract infection and no perineal diseases such as fistulas, genital mutilation, previous perineal surgery for pelvic floor dysfunction or Crohn's disease. According to the Robson 10-Group Classification System, only women belonging to group 1 (nulliparous women with a single vital cephalic pregnancy, ≥37 weeks of gestation in spontaneous labor) and group 2a (nulliparous women with a single vital cephalic pregnancy, ≥37 weeks of gestation who had labor induced) will be included in the study. Exclusion Criteria: * Women with conditions such as severe pre-eclampsia or infections, sick newborns or women who refuse to take part in the study will not be included. Participation is voluntary and participants can withdraw from the study at any time.
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What it tests

  • Physiotherapeutic protocol
  • Usual maternity care
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Where

1 site
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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