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Trials / Recruiting

RecruitingNCT07099690

Perineal Massage During Labor for the Prevention of Perineal Trauma

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
466 (estimated)
Sponsor
Federal University of Rio Grande do Sul · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDUREPerineal massagePerineal 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.

Timeline

Start date
2024-04-02
Primary completion
2026-07-30
Completion
2026-12-15
First posted
2025-08-01
Last updated
2025-08-26

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT07099690. Inclusion in this directory is not an endorsement.