Physiotherapy and cold‑pack treatment for first-time mothers with perineal tears after vaginal delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, hybrid effectiveness–implementation trial will enroll 82 primiparous women with grade ≥2 perineal lacerations or episiotomy at a single university hospital. Participants will be randomly assigned to usual maternity care (sutures and analgesics) or usual care plus a physiotherapy protocol consisting of one in-person session with 20 minutes of cryotherapy and pelvic floor muscle instruction followed by 12 weekly remote pelvic floor training sessions. Pain intensity is the primary outcome and will be measured repeatedly from hours after delivery through 3 and 6 months postpartum; a blinded assessor and an economic evaluation are included. The intervention emphasizes early initiation of pelvic floor exercises and as‑needed cryotherapy to address acute perineal pain and support recovery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
  Ribeirão Preto, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Caroline Soares de Paula
• Email: carolinesoarespaula@gmail.com
• Phone: +55 19 996307633

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.