Status:
RECRUITING
Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma
Lead Sponsor:
University of Sao Paulo
Conditions:
Episiotomy
Lacerations Perineal
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 pri...
Detailed Description
This study is a type 1 hybrid randomised controlled clinical trial of effectiveness-implementation, with economic evaluation and blinded assessor, which aims to assess the effectiveness and cost-effec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2029
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT07170007
Start Date
November 11 2025
End Date
March 20 2029
Last Update
November 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil, 14049-900