Perineal Massage During Labor for the Prevention of Perineal Trauma

August 19, 2025 updated by: Gabriela Plentz Stein, Federal University of Rio Grande do Sul

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

466

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perineal Massage Group
The perineal massage group will receive the intervention during labor.
Procedure: Perineal massage

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.
No Intervention: Control Group
The control group will receive the standard care provided by the obstetric center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of perineal trauma (laceration or episiotomy) during vaginal delivery
Time Frame: At the time of 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2024

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

July 25, 2025

First Submitted That Met QC Criteria

July 25, 2025

First Posted (Actual)

August 1, 2025

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstetric; Injury Pelvic Floor

Clinical Trials on Perineal massage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe