Menu
Recruiting NCT07099690

Perineal Massage During Labor for the Prevention of Perineal Trauma

No phase Interventional Obstetric; Injury Pelvic Floor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Perineal massage.
Who it may be relevant to
Registry conditions: Obstetric; Injury Pelvic Floor. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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 per

Primary outcome measures

  • Incidence of perineal trauma (laceration or episiotomy) during vaginal delivery [Time frame: At the time of delivery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Brazil · 1 center
  • Hospital de Clínicas de Porto Alegre — Porto Alegre

Identifiers

NCT: NCT07099690 · 2023-0514

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗