New moms may get pain relief from pelvic floor therapy after birth tears
NCT ID NCT07170007
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding a physiotherapy protocol—pelvic floor muscle training and cold therapy—to standard care can reduce perineal pain in first-time mothers who had tears or an episiotomy during vaginal delivery. 82 women will be randomly assigned to either usual care (stitches and painkillers) or usual care plus the physiotherapy program starting right after birth and lasting 3 months. The main goal is to see if pain levels improve, with secondary checks on pelvic floor function, quality of life, and recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pelvic floor muscle training and cryotherapy
- What this could lead to
- If it works, this could offer a simple, drug-free way to reduce pain and improve recovery after childbirth injuries.
- What could go wrong
- This is a small, early-stage trial with only 82 participants, so results may not apply to all women. The benefit over usual care may be small or none.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 82 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
RECRUITINGRibeirão Preto, São Paulo, 14049-900, Brazil
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gel vs ointment: which helps new mothers heal faster after episiotomy?
- A new weapon against birth tears? pelvic floor training put to the test
- Could a boric acid dressing soothe Post-Birth pain and speed healing?
- A quick ultrasound during labor may predict perineal tears and C-Section risk
- Radiofrequency waves tested as a Drug-Free pain relief for new mothers
- A shot of your own blood may heal birth tears faster