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Completed

NCT Number: NCT07626333

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Okuyan

Batman, Turkey (Türkiye)

About this study

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..

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: The education program

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Batman Training and Research Hospital

Other Gov

Collaborators

  • Batman University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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