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

June 2, 2026 updated by: Erhan Okuyan,M.D, Batman Training and Research Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In recent years, there has been mounting interest in the application of non-pharmacological modalities during labor and delivery. Pelvic floor muscle training (PFMT) has emerged as one of the most extensively studied antenatal strategies. A systematic review and meta-analysis of randomized clinical trials demonstrated that PFMT during pregnancy significantly reduces the risk of urinary incontinence and third- or fourth-degree perineal tears; however, its effect on episiotomy rates did not reach statistical significance . Another meta-analysis corroborated these findings, showing that antenatal PFMT shortens the second stage of labor and lowers the incidence of severe perineal trauma . A more recent Bayesian network meta-analysis ranked antenatal pelvic floor exercise as the optimal first-line strategy for overall perineal laceration prevention, with a 50% risk reduction (RR = 0.50, 95% CrI 0.28-0.87) .

Perineal massage applied either antenatally or during the second stage-represents another effective non-pharmacological intervention. By increasing the elasticity and distensibility of the perineal tissues, massage facilitates gradual stretching of the birth canal. A meta-analysis of randomized controlled trials reported that antenatal perineal massage was associated with a significantly lower incidence of episiotomies (RR = 0.79, 95% CI 0.72-0.87, p < 0.001) and perineal tears, as well as reduced second-stage duration and improved postpartum outcomes . When applied during labor, perineal massage has also been shown to reduce the risk of severe perineal trauma, although its independent effect on episiotomy remains variable across studies .

The Swiss ball, a widely accessible tool for promoting pelvic mobility and maternal comfort during labor, constitutes a third non-pharmacological option. Active pelvic movements performed on a Swiss ball including pelvic anteversion, retroversion, lateral tilts, and circular hip movements have been shown in a randomized trial to reduce the duration of the first and second stages of labor, decrease pain intensity, diminish maternal fatigue and anxiety, and lower the risk of cesarean section and vulvar swelling . An updated meta-analysis of randomized controlled trials further confirmed that birthing ball exercises significantly reduce cesarean section rates and alleviate labor pain, supporting their use as a safe and effective intervention in low-risk labor management .

The present study was designed to address this knowledge gap. Investigators hypothesized that in pregnant women who completed nurse-led pelvic floor education sessions at least once weekly until delivery, the addition of Swiss ball exercises or perineal massage during labor would reduce episiotomy requirements. The primary objective was to compare the effects of four non-pharmacological interventions pelvic floor muscle training, combined PFMT and Swiss ball exercises, combined PFMT and perineal massage, and standard care on delivery outcomes and episiotomy-related parameters..

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Failure to meet any of the above inclusion criteria
  • Declining to provide written informed consen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Other Names:
  • The education program
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
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.
Other Names:
  • The education program
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
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.
Other Names:
  • The education program
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
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.
Other Names:
  • The education program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Episiotomy rate
Time Frame: 7 days

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
Time Frame: 7 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Batman Training and Research Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Batman University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erhan Okuyan, Batman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Date: January 8, 2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to ethical restrictions and the absence of explicit participant consent for public data sharing, individual participant data cannot be made publicly available. Data may be shared upon reasonable request, subject to approval by the institutional ethics committee and a data sharing agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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