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- Ensayo clínico NCT07626333
Pelvic Floor Training Combined With Perineal Massage Reduces Episiotomy to 5.7%
Pelvic Floor Training Combined With Perineal Massage Reduces Episiotomy to 5.7%: A Four Arm Randomized Controlled Trial
Descripción general del estudio
Estado
Descripción detallada
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..
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Batman, Turquía (Türkiye)
- Okuyan
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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1/Control
The control group received standard antenatal care without any additional intervention.
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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.
Otros nombres:
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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
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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.
Otros nombres:
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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
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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.
Otros nombres:
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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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Episiotomy rate
Periodo de tiempo: 7 days
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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
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Degree of perineal laceration
Periodo de tiempo: 7 days
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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
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Erhan Okuyan, Batman Training and Research Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Date: January 8, 2026
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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