EpisiotomyNCT07626333
Pelvic Floor Training Combined With Perineal Massage Reduces Episiotomy to 5.7%
A study testing Standart antenatal care, Pelvic Floor Muscle Exercises (PMFE) and Swiss Ball in people with Episiotomy and Episiotomy Extended by Laceration, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy, Episiotomy Extended by Laceration, Pelvic Floor Awareness
- What is being tested?
- Standart antenatal care, Pelvic Floor Muscle Exercises (PMFE) and Swiss Ball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2024to 5 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Failure to meet any of the above inclusion criteria
- Declining to provide written informed consen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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..
- Being tested
- Standart antenatal care, Pelvic Floor Muscle Exercises (PMFE), Swiss Ball, Perineal Massage, Education program
- Keywords
- Episiotomy, pelvic floor muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standart antenatal careOther
Standart antenatal care
Pelvic Floor Muscle Exercises (PMFE)Behavioural
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.
Swiss BallBehavioural
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.
Perineal MassageBehavioural
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.
Education programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1/ Standart antenatal care | Active comparator | 1/ The control group received standard antenatal care without any additional intervention. Receives: 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 Receives: 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 Receives: 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. Receives: Behavioral: Pelvic Floor Muscle Exercises (PMFE); Behavioral: Education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start5 Jan 2024
- Primary completion5 Jan 2025
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Batman University
- Responsible party
- Principal investigator, Erhan Okuyan,M.D, Batman Training and Research Hospital
- Investigators
- Erhan Okuyan, Principal investigator, Batman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626333
- Sponsor's protocol ID
- Date: January 8, 2026
- Status last verified
- Sep 2026
- First submitted
- 28 May 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Training Combined With Perineal Massage Reduces Episiotomy to 5.7%: A Four Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07626333
- Acronym / sponsor ID
- Date: January 8, 2026
- Keywords
- Episiotomy, pelvic floor muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Batman Training and Research HospitalOther government
- Collaborators
- Batman University
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1/ Standart antenatal care | Active comparator | Other: Standart antenatal care1/ The control group received standard antenatal care without any additional intervention. |
| 2/PMFE+PERİNEAL MASSAGE | Active comparator | Behavioral: Perineal Massage, Behavioral: Education programArm 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 |
| 3/PMFE+SWISS BALL | Active comparator | Behavioral: Swiss Ball, Behavioral: Education programThe 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 |
| 4/PMFE | Active comparator | Behavioral: Pelvic Floor Muscle Exercises (PMFE), Behavioral: Education programIThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Failure to meet any of the above inclusion criteria
- Declining to provide written informed consen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standart antenatal careStandart antenatal care | Other | 1/ Standart antenatal care |
| 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. | Behavioural | 4/PMFE |
| Swiss BallSwiss 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. | Behavioural | 3/PMFE+SWISS BALL |
| Perineal MassageDigital 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. | Behavioural | 2/PMFE+PERİNEAL MASSAGE |
| Education programThe 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. | Behavioural | 2/PMFE+PERİNEAL MASSAGE, 3/PMFE+SWISS BALL, 4/PMFE |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erhan Okuyan principal investigator
Batman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standart antenatal care, Pelvic Floor Muscle Exercises (PMFE) and Swiss Ball in people with Episiotomy and Episiotomy Extended by Laceration, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episiotomy rate (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.