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Perineal Massage During Labor for the Prevention of Perineal Trauma

Perineal Massage During Labor for the Prevention of Perineal Trauma

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07099690
Enrollment
466
Registered
2025-08-01
Start date
2024-04-02
Completion date
2026-12-15
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric; Injury Pelvic Floor

Keywords

Perineal trauma, Episiotomy, Perineal massage, Laceration

Brief summary

The purpose of this study is to evaluate whether perineal massage during labor can help prevent perineal trauma, such as lacerations or episiotomies. The study will test two hypotheses: Null hypothesis: Perineal massage during labor does not prevent perineal trauma. Alternative hypothesis: Perineal massage during labor helps prevent perineal trauma. Participants will be randomly assigned to one of two groups: Perineal massage group: Participants will receive perineal massage during labor. Control group: Participants will receive the standard care provided by the labor and delivery unit. A randomization process will be used to assign participants to each group.

Interventions

Perineal massage will be performed during labor, either between or during contractions, regardless of the position chosen by the laboring woman. The researcher, wearing gloves, will insert one or two fingers (index and middle) into the participant's vaginal canal and move them from side to side in a U-shaped motion, for approximately one second in each direction. Light downward pressure will be applied toward the rectum, according to the woman's tolerance, until relaxation of the massaged perineal muscles is observed. A water-based lubricant will be used to facilitate the procedure. The massage will last no longer than 5 minutes.

Sponsors

Federal University of Rio Grande do Sul
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of perineal trauma (laceration or episiotomy) during vaginal deliveryAt the time of deliveryThe presence and degree of perineal trauma will be assessed after delivery by the attending healthcare provider. Trauma will be classified by the presence of spontaneous perineal lacerations (graded I to IV) and/or performance of episiotomy.

Countries

Brazil

Contacts

Primary ContactGabriela Plentz Stein
gabrielaplentz.fisio@gmail.com+55 51997710248

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026