Recruiting

NCT Number: NCT07099690

Perineal Massage During Labor for the Prevention of Perineal Trauma

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.

Recruiting

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Key information

Conditions

Obstetric; Injury Pelvic Floor Lacerations Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

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

Location status: Recruiting

Location contact

Gabriela Stein

CONTACT

[email protected]

+5551997710248

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela Plentz Stein

CONTACT

[email protected]

+55 51997710248

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Aug 1, 2025
Registry last updated: Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed