Perineal massage during labor to prevent perineal tears
Perineal Massage During Labor for the Prevention of Perineal Trauma
This will test whether perineal massage during labor helps prevent perineal tears or the need for an episiotomy in people at term with a head-down baby.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 466 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Federal University of Rio Grande do Sul Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Trial ID | NCT07099690 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study assigns people in labor to either receive perineal massage during labor or to receive standard care without massage. Eligible participants are at 37–42 weeks' gestation with a cephalic-presenting fetus and no prior antenatal perineal massage, while those who progress to cesarean delivery, develop HELLP syndrome, or have unstable maternal or fetal vital signs are excluded. Perineal massage will be performed at the bedside according to the site's protocol and outcomes will focus on rates of perineal laceration and episiotomy. The trial is conducted at Hospital de Clínicas de Porto Alegre, led by the Federal University of Rio Grande do Sul.
Who should consider this trial
Good fit: Ideal candidates are people in active labor at 37–42 weeks with a head-down (cephalic) fetus who have not done perineal massage during prenatal care.
Not a fit: Patients who require cesarean delivery, have HELLP syndrome, or have unstable maternal or fetal vital signs are unlikely to benefit because they are excluded or cannot receive the intervention.
Why it matters
Potential benefit: If successful, this could reduce perineal tears and the need for episiotomy, improving postpartum recovery and lowering pelvic floor injury risk.
How similar studies have performed: Previous randomized trials and meta-analyses have shown mixed results, with some studies reporting reduced severe tears or episiotomy rates and others showing minimal effect.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients currently in labor * Gestational age between 37 and 42 weeks * Fetus presenting in cephalic position * No prior perineal massage performed during prenatal care Exclusion Criteria: * Patients who progress to cesarean delivery * Diagnosis of HELLP syndrome * Unstable vital signs of the laboring woman or fetus
Where this trial is running
Porto Alegre, Rio Grande do Sul
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
Study contacts
- Study coordinator: Gabriela Plentz Stein
- Email: gabrielaplentz.fisio@gmail.com
- Phone: +55 51997710248
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.