Physiotherapy and cold‑pack treatment for first-time mothers with perineal tears after vaginal delivery
Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Postpartum Primiparas After Perineal Trauma: A Type 1 Hybrid Effectiveness-Implementation Randomized Controlled Trial With Economic Evaluation
This will test whether pelvic floor muscle exercises plus cryotherapy started right after birth reduce perineal pain for first-time mothers who had a grade 2 or higher tear or an episiotomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (Ribeirão Preto, São Paulo) |
| Trial ID | NCT07170007 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Primiparous women aged 18 or older at ≥37 weeks gestation who delivered vaginally at the study hospital and sustained a grade 2 or higher perineal tear or an episiotomy, belonging to Robson group 1 or 2a and without neurological disease, active infection, or prior pelvic‑floor surgery are ideal candidates.
Not a fit: Women with minor perineal injuries (below grade 2), cesarean delivery, severe pre‑eclampsia or active infection, significant neurological disease, prior pelvic‑floor surgery, or conditions preventing participation in remote sessions are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the combined pelvic floor training and cryotherapy approach could reduce acute perineal pain and improve postpartum pelvic floor recovery for first-time mothers.
How similar studies have performed: Pelvic floor muscle training has shown benefits for postpartum pelvic function in other studies, but initiating PFMT immediately after delivery combined with cryotherapy for acute perineal pain is a relatively novel approach with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ribeirão Preto, São Paulo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.