An interventional study of Perineal massage in Obstetric; Injury Pelvic Floor, sponsored by Federal University of Rio Grande do Sul. Recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Prevention
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.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 466 is above the median of 65 across 128 interventional studies indexed under Lacerations.
Browse Lacerations studies →Federal University of Rio Grande do Sul is the lead sponsor of 121 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
The perineal massage group will receive the intervention during labor.
Procedure: Perineal massage
The control group will receive the standard care provided by the obstetric center.
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.
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started Apr 2024 (actual). Primary completion is estimated for Jul 2026, 27 months after the start.
Of 46 non-industry interventional studies with no phase under Lacerations, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 72. This study's planned 27 months is above that.
Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 12 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
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