Perineal Massage During Labor for the Prevention of Perineal Trauma

Federal University of Rio Grande do Sul

Status: Enrolling

Conditions: Obstetric; Injury Pelvic Floor

Treatments: Procedure: Perineal massage

Study type: Interventional

Funder types: Other

Identifiers

NCT07099690

2023-0514

Details and patient eligibility

About

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.

Enrollment: 466 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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466 participants in 2 patient groups

Perineal Massage Group

Experimental group

Description:

The perineal massage group will receive the intervention during labor.

Treatment:

Procedure: Perineal massage

Control Group

No Intervention group

Description:

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