Clinical trial NCT06568406: Impact of Early Physiotherapy on Pain, Quality of Life, Pelvic Floor Function, and Sexual Health Post-Episiotomy
Official title: Definition of the Effect of Early Individual Physiotherapy on Evaluation of Pain, Quality of Life, Function of the Pelvic Floor Muscles, and on the Sexual Functions in Women Following an Episiotomy During a Delivery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecological; Surgery (Previous), Causing Obstructed Labor
Keywords: Episiotomy
physiotherapy
pelvic floor
scar
pain
dyspareunia
sexual dysfunction
quality of life
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgical incision of the perineum and the posterior vaginal wall during a vaginal delivery (episiotomy) is among the most common surgical procedures performed in obstetrics. On the condition of having been performed correctly and in certain situations, episiotomy can be beneficial for a mother in decreasing the risk of a serious perineum injury. The benefit for a foetus can lie in acceleration of the final stage of delivery in the event of acute foetal distress. Many adverse effects are however connected to episiotomy. The morbidity connected to episiotomy can affect physical, mental, and social well-being of women during immediate as well as long-term post-partum periods. Currently, there are no universal standards that would describe and recommend physiotherapy for women following episiotomy during the first days, weeks, and months after a delivery. Care about the wound and the resulting scar after giving birth with episiotomy is an important topic because clinical experience shows that scars in the perineal area can have negative effects on the function of the pelvic floor muscles, on perineum pains, sexual health, and on mental well-being of a woman. Treatment of women with perineal wounds therefore requires a multidisciplinary approach, in which doctors, physiotherapists, and other medical professionals should be aware of the impact of a perineal scar on the quality of woman's life. Treatment or perineal scars, external genitalia, and the pelvic floor together with a targeted education of women in individual care after their scars should be part of evidence-based practice.

Detailed description: Project Objectives Evaluate the benefits, advantages, and disadvantages of early individual physiotherapy on the selected parameters in women following a performed uncomplicated episiotomy during a vaginal delivery.

Primary objective: Specification of the differences between two groups of expectant mothers following an uncomplicated episiotomy based on the results of a survey. The comparison is carried out between a group of mothers who underwent individual postnatal physiotherapy treatment and another group of mothers that were treated in a standard way.

Secondary objective: Evaluation of the functional changes in mothers that underwent individual physiotherapeutic treatment following an uncomplicated episiotomy.

Eligibility criteria: Inclusion Criteria:

* female aged 18 to 40
* following an uncomplicated mediolateral episiotomy
* primipara at term with the cephalic occiput anterior position of the foetus
* signature of the informed consent and understanding of the study protocol

Exclusion Criteria:

* premature birth prior to 37+0
* other presentation than the cephalic occiput anterior position
* a performed vaginal extraction
* an associated vaginal rupture
* an injury of the anal sphincter
* paravaginal haematoma immediately after birth and before inclusion in the study
* multiple sclerosis
* serious neurological disorders
* connective tissue diseases
* chronic inflammatory bowel diseases
* congenital developmental disorders of the external genitalia

Primary outcomes:
measure: Pain in the perineal space
timeFrame: Change from baseline to 14-18 weeks and 12-14 months
measure: Complications of healing of birth trauma
timeFrame: Change from baseline to 14-18 weeks and 12-14 months
measure: Pain in the perineum in relation to bodily and motor functions
timeFrame: Change from baseline to 14-18 weeks and 12-14 months
Secondary outcomes:
measure: The quality of sexual functions
timeFrame: Change from baseline to 14-18 weeks and 12-14 months
measure: Quality of life of people with urinary incontinence
timeFrame: Change from baseline to 14-18 weeks and 12-14 months
measure: Health related quality of life
timeFrame: Change from baseline to 14-18 weeks and 12-14 months
measure: The functions of the pelvic floor muscles by palpation per vaginam and records them using the OXFORD SCALE
timeFrame: Change from baseline to 10-14 weeks
measure: The functions of the pelvic floor muscles by palpation per vaginam and records them using the PERFECT SCHEME
timeFrame: Change from baseline to 10-14 weeks
measure: The presence of possible motion synkinesis
timeFrame: Change from baseline to 10-14 weeks
measure: The condition of the wound
timeFrame: Change from baseline to 10-14 weeks
measure: The condition of the scar
timeFrame: Change from baseline to 10-14 weeks
measure: The presence of the abdominal separation
timeFrame: Change from baseline to 10-14 weeks
measure: Hypermobility
timeFrame: Change from baseline to 10-14 weeks
measure: Satisfaction with physiotherapy
timeFrame: Change from baseline to 10-14 weeks
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital
Study officials:
affiliation: University Hospital Brno, Czechia
name: Lukáš Hruban, PhD
role: PRINCIPAL_INVESTIGATOR
References: