Impact of Early Physiotherapy on Pain, Quality of Life, Pelvic Floor Function, and Sexual Health Post-Episiotomy

Brno University Hospital

Status: Enrolling

Conditions: Gynecological; Surgery (Previous), Causing Obstructed Labor

Treatments: Diagnostic Test: Urogynaecology; Procedure: Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06568406

Epi-Fyzio

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

250 participants in 2 patient groups

Scheduled Physiotherapy (Intervention)

Experimental group

Description:

The mothers in the group A will be referred to the physiotherapist's office at predetermined intervals (intervention group) compared to the current care system.

Treatment:

Procedure: Physiotherapy

Diagnostic Test: Urogynaecology

Standard Care (Control)

Active Comparator group

Description:

The mothers included in the group B will undergo standard care in the established manner at the Department of Obstetrics and Gynecology of the Faculty Hospital in Brno, which consists of routine treatment of the perineum and inspection of the perineum by a doctor that by rule occurs the 3rd day after delivery and by the end of the hospitalization

Treatment:

Diagnostic Test: Urogynaecology