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

2 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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..

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

520

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
1/Control
The control group received standard antenatal care without any additional intervention.
Behawioralne: 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.
Inne nazwy:
  • 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
Behawioralne: 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.
Inne nazwy:
  • 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
Behawioralne: 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.
Inne nazwy:
  • 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.
Behawioralne: 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.
Inne nazwy:
  • The education program

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Episiotomy rate
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Batman Training and Research Hospital

Współpracownicy

Batman University

Śledczy

  • Główny śledczy: Erhan Okuyan, Batman Training and Research Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

5 lutego 2026

Zakończenie podstawowe (Rzeczywisty)

5 kwietnia 2026

Ukończenie studiów (Rzeczywisty)

5 kwietnia 2026

Daty rejestracji na studia

Pierwszy przesłany

28 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

4 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 czerwca 2026

Ostatnia weryfikacja

1 stycznia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Date: January 8, 2026

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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