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COMPLETED
NCT07626333
NA

Pelvic Floor Training Combined With Perineal Massage Reduces Episiotomy to 5.7%

Sponsor: Batman Training and Research Hospital

View on ClinicalTrials.gov

Summary

Episiotomy, a surgical incision of the perineum performed during the second stage of labor, was once widely advocated for the prevention of severe perineal lacerations. However, a growing body of evidence has demonstrated that routine episiotomy is not without consequence: it is associated with increased rates of posterior perineal trauma, dyspareunia, perineal pain, and postpartum hemorrhage. In alignment with this evidence, the World Health Organization now recommends against routine or liberal episiotomy use and endorses a restrictive approach, targeting episiotomy rates below 10%. Despite these recommendations, episiotomy rates remain high in many settings, particularly among nulliparous womenDespite the individual promise of these modalities, few studies have evaluated their combined effects on episiotomy and other perineal outcomes. The different mechanisms through which PFMT, perineal massage, and Swiss ball exercises operate suggest that their concurrent use may yield additive or synergistic benefits. Nevertheless, comparative data examining PFMT alone versus PFMT combined with Swiss ball or perineal massage remain scarce.

Official title: Pelvic Floor Training Combined With Perineal Massage Reduces Episiotomy to 5.7%: A Four Arm Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

431

Start Date

2024-01-05

Completion Date

2026-04-05

Last Updated

2026-09-22

Healthy Volunteers

Yes

Interventions

OTHER

Standart antenatal care

Standart antenatal care

BEHAVIORAL

Pelvic Floor Muscle Exercises (PMFE)

Pelvic floor muscle exercises (Kegel exercises) were taught to pregnant women by a nurse on an individual basis, starting from the 34th gestational week. Each participant received one-to-one instruction during at least three separate visits, and each session lasted at least 10 minutes. The training included identification of the correct pelvic floor muscles, proper contraction and relaxation techniques, and confirmation that the contraction was performed correctly. Participants were instructed to perform the exercises regularly at home until delivery.

BEHAVIORAL

Swiss Ball

Swiss ball (exercise ball) techniques were taught to pregnant women by a nurse on an individual basis, starting from the 34th gestational week. Each participant received one-to-one instruction during at least three separate visits, and each session lasted at least 10 minutes. The training included active pelvic movements on the Swiss ball, such as pelvic anteversion, pelvic retroversion, lateral pelvic tilts, and circular hip movements, according to individual obstetric evaluation. Participants were instructed to perform these movements during labor.

BEHAVIORAL

Perineal Massage

Digital perineal massage was taught to pregnant women by a nurse on an individual basis, starting from the 34th gestational week. Each participant received one-to-one instruction during at least three separate visits, and each session lasted at least 10 minutes. The training included identification of the perineal area, correct massage technique, use of lubricant, and safe application. Participants were instructed to perform perineal massage at least once daily at home from the 34th gestational week until delivery.

BEHAVIORAL

Education program

The education program was delivered to pregnant women by a nurse on an individual basis, starting from the 34th gestational week. Each participant received one-to-one instruction during at least three separate visits, and each session lasted at least 10 minutes. The education program covered pelvic floor anatomy and function, identification of correct pelvic floor muscle contraction, performance of Kegel exercises, and diaphragmatic breathing techniques. All participants in the intervention groups attended nurse-led pelvic floor education sessions at least once per week until delivery.

Locations (1)

Okuyan

Batman, Turkey (Türkiye)