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

NCT07626333 | Completed

• 1 other identifier: Date: January 8, 2026
• Study Type: interventional
• Target: 431
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Episiotomy; Episiotomy Extended by Laceration; Pelvic Floor Awareness

Keywords

Episiotomy; pelvic floor muscle training

Outcome Measures

Primary Outcomes (2)

• Episiotomy rate

  Outcome Measure 1: Episiotomy rate. The presence of episiotomy (yes/no) was recorded on a clinical follow-up form. Between-group comparisons were performed using this binary outcome. Time Frame: 7 days after delivery.

  7 days

• Degree of perineal laceration

  Outcome Measure 2: Degree of perineal laceration. The severity of perineal trauma was classified as 1st, 2nd, 3rd, or 4th degree laceration based on clinical examination and recorded on the same form. Between-group comparisons were performed for this ordinal outcome. Time Frame: 7 days after delivery

  7 days

Study Arms (4)

1/ Standart antenatal care

ACTIVE COMPARATOR

1/ The control group received standard antenatal care without any additional intervention.

Other: Standart antenatal care

2/PMFE+PERİNEAL MASSAGE

ACTIVE COMPARATOR

Arm 2/PMFE+Perineal Massage: The education program, PMFE, Perineal Massage . All participants were taught digital perineal massage to be performed at least once daily from the 34th gestational week until delivery

Behavioral: Perineal Massage; Behavioral: Education program

3/PMFE+SWISS BALL

ACTIVE COMPARATOR

The education program, PMFE, Swiss Ball Exercises. All participants additionally performed active pelvic movements on a Swiss ball during labor, including pelvic anteversion, retroversion, lateral pelvic tilts, and circular hip movements, according to individual obstetric evaluation

Behavioral: Swiss Ball; Behavioral: Education program

4/PMFE

ACTIVE COMPARATOR

IThe education program, PMFE. Pelvic floor muscle exercises were performed by a nurse at least once a week for at least one hour from week 34 onward.

Behavioral: Pelvic Floor Muscle Exercises (PMFE); Behavioral: Education program

Interventions

Standart antenatal care OTHER

Standart antenatal care

1/ Standart antenatal care

Pelvic Floor Muscle Exercises (PMFE) BEHAVIORAL

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.

4/PMFE

Swiss Ball BEHAVIORAL

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.

3/PMFE+SWISS BALL

Perineal Massage BEHAVIORAL

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.

2/PMFE+PERİNEAL MASSAGE

Education program BEHAVIORAL

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.

2/PMFE+PERİNEAL MASSAGE; 3/PMFE+SWISS BALL; 4/PMFE

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Age ≥ 18 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• No prior exposure to any of the study interventions
• Gestational age between 20 and 36 weeks at the time of enrollment
• No history of previous episiotomy
• Estimated fetal weight between 3,000 and 4,000 grams
• No labor induction
• Absence of any systemic disease complicating the current pregnancy
• No regular use of medications or supplements other than multivitamins
• Pre-pregnancy body mass index within the range of 18-25 kg/m²

You may not qualify if:

• Declining to provide written informed consen

Sponsors & Collaborators

• Batman University: collaborator
• Batman Training and Research Hospital: lead

Study Sites (1)

Okuyan

Batman, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Erhan Okuyan

  Batman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof. M.D

Model Details: This study tested the hypothesis that, among pregnant women completing weekly nurse-led pelvic floor education until delivery, adding Swiss ball exercises or perineal massage would reduce episiotomy rates. The primary objective was to compare the four interventions, PFMT alone, PFMT + Swiss ball exercises, PFMT + perineal massage, and standard care, on episiotomy and related obstetric outcomes.

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 4, 2026
• Study Start: January 5, 2024
• Primary Completion: January 5, 2025
• Study Completion: April 5, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)