Perineal Massage During Labor for the Prevention of Perineal Trauma

NCT07099690 | Recruiting DMC

• 1 other identifier: 2023-0514
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric; Injury Pelvic Floor

Keywords

Perineal trauma; Episiotomy; Perineal massage; Laceration

Outcome Measures

Primary Outcomes (1)

• Incidence of perineal trauma (laceration or episiotomy) during vaginal delivery

  The 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.

  At the time of delivery

Study Arms (2)

Perineal Massage Group

EXPERIMENTAL

The perineal massage group will receive the intervention during labor.

Procedure: Perineal massage

Control Group

NO INTERVENTION

The control group will receive the standard care provided by the obstetric center.

Interventions

Perineal massage PROCEDURE

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.

Perineal Massage Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients currently in labor
• Gestational age between 37 and 42 weeks
• Fetus presenting in cephalic position
• No prior perineal massage performed during prenatal care

You may not qualify if:

• Patients who progress to cesarean delivery
• Diagnosis of HELLP syndrome
• Unstable vital signs of the laboring woman or fetus

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Gabriela Plentz Stein

CONTACT

+55 51997710248; gabrielaplentz.fisio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: April 2, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

BR (1)