Perineal Massage During Labor for the Prevention of Perineal Trauma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorFederal University of Rio Grande do Sul

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients currently in labor

Gestational age between 37 and 42 weeks

Fetus presenting in cephalic position

No prior perineal massage performed during prenatal care

Disqualifiers

Patients who progress to cesarean delivery

Diagnosis of HELLP syndrome

Unstable vital signs of the laboring woman or fetus

Trial design

Design model

Parallel

Treatments tested in this trial

  • Perineal massage

    Procedure/Surgery

    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.

Treatment groups

466 Participants
are divided into 2 treatment groups
Group A: Perineal Massage GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

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.

Time frame
At the time of delivery

Secondary outcomes

Other outcomes

Sponsors and contacts

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