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

NCT ID: NCT06568406

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-12-31

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.

Conditions

Gynecological; Surgery (Previous), Causing Obstructed Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Scheduled Physiotherapy (Intervention)

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.

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: PROCEDURE

Examination by a physiotherapist: the first check-up with an examination and a therapeutic intervention with the patient is performed within 24-72 hours after delivery. This is followed by two regular outpatient check-ups by a physiotherapist for the purpose of therapy and education. The second check takes place after 6-8 weeks. And the third check occurs after 10-14 weeks after childbirth. In these three checks, data collection is carried out simultaneously (in order to complete the secondary objective). The patients are examined and monitored by the same physiotherapist.

Urogynaecology

Intervention Type: DIAGNOSTIC_TEST

Examination by a urogynaecologist this is carried out in the period of 14-18 weeks after childbirth in order to complete the primary objective. Data collection in order to complete the primary objective is done in the period of 14-18 weeks and 12-14 months after delivery (the online method without the need for a physical visit is preferred).

Standard Care (Control)

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

Group Type: ACTIVE_COMPARATOR

Urogynaecology

Intervention Type: DIAGNOSTIC_TEST

Examination by a urogynaecologist this is carried out in the period of 14-18 weeks after childbirth in order to complete the primary objective. Data collection in order to complete the primary objective is done in the period of 14-18 weeks and 12-14 months after delivery (the online method without the need for a physical visit is preferred).

Interventions

Physiotherapy

Examination by a physiotherapist: the first check-up with an examination and a therapeutic intervention with the patient is performed within 24-72 hours after delivery. This is followed by two regular outpatient check-ups by a physiotherapist for the purpose of therapy and education. The second check takes place after 6-8 weeks. And the third check occurs after 10-14 weeks after childbirth. In these three checks, data collection is carried out simultaneously (in order to complete the secondary objective). The patients are examined and monitored by the same physiotherapist.

Intervention Type: PROCEDURE

Urogynaecology

Examination by a urogynaecologist this is carried out in the period of 14-18 weeks after childbirth in order to complete the primary objective. Data collection in order to complete the primary objective is done in the period of 14-18 weeks and 12-14 months after delivery (the online method without the need for a physical visit is preferred).

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ladislav Batalik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lukáš Hruban, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Brno, Czechia

Locations

University Hospital

Brno, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Lukáš Hruban, PhD

Role: CONTACT

hruban.lukas@fnbrno.cz

00420532238306

Marika Bajerová, MSc

Role: CONTACT

bajerova.marika@fnbrno.cz

00420532238359

Facility Contacts

Marika Bajerová, MSc.

Role: primary

Bajerova.Marika@fnbrno.cz

Other Identifiers

Epi-Fyzio

Identifier Type: -

Identifier Source: org_study_id