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

NCT07626333 | Completed

• 1 other identifier: Date: January 8, 2026
• Study Type: observational
• Target: 520
• 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/Control

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

Behavioral: The education program covered pelvic floor anatomy and function, identification of correct muscle contraction, performance of Kegel exercises, and diaphragmatic breathing techniques

2/PMFE+PERİNEAL MASSAGE

All participants were taught digital perineal massage to be performed at least once daily from the 34th gestational week until delivery

Behavioral: The education program covered pelvic floor anatomy and function, identification of correct muscle contraction, performance of Kegel exercises, and diaphragmatic breathing techniques

3/PMFE+SWISS BALL

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: The education program covered pelvic floor anatomy and function, identification of correct muscle contraction, performance of Kegel exercises, and diaphragmatic breathing techniques

4/PMFE

In Group 4, pelvic floor muscle exercises were performed by a nurse at least once a week for at least one hour from week 34 onward.

Behavioral: The education program covered pelvic floor anatomy and function, identification of correct muscle contraction, performance of Kegel exercises, and diaphragmatic breathing techniques

Interventions

The education program covered pelvic floor anatomy and function, identification of correct muscle contraction, performance of Kegel exercises, and diaphragmatic breathing techniques BEHAVIORAL

All participants in the intervention groups attended nurse-led pelvic floor education sessions at least once per week until delivery. The education program covered pelvic floor anatomy and function, identification of correct muscle contraction, performance of Kegel exercises, and diaphragmatic breathing techniques.

Also known as: The education program

1/Control; 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+)
• Sampling Method: Probability Sample

Study Population

The study population consisted of pregnant women who presented to the participating healthcare facility and met the following predefined inclusion criteria. Participants who did not satisfy these criteria or who declined to provide written informed consent were excluded. All participants provided written informed consent prior to enrollment. The study was conducted in accordance with the Declaration of Helsinki and received approval from the institutional ethics committee.

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

Functional Status

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Erhan Okuyan

  Batman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof. M.D

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 4, 2026
• Study Start: February 5, 2026
• Primary Completion: April 5, 2026
• Study Completion: April 5, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)