NCT06568406 Impact of Early Physiotherapy on Pain, Quality of Life, Pelvic Floor Function, and Sexual Health Post-Episiotomy
| NCT ID | NCT06568406 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brno University Hospital |
| Condition | Gynecological; Surgery (Previous), Causing Obstructed Labor |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2024-10-01 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Lukáš Hruban, PhD
PRINCIPAL INVESTIGATOR
University Hospital Brno, Czechia
Frequently Asked Questions
Who can join the NCT06568406 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Gynecological; Surgery (Previous), Causing Obstructed Labor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06568406 currently recruiting?
Yes, NCT06568406 is actively recruiting participants. Contact the research team at hruban.lukas@fnbrno.cz for enrollment information.
Where is the NCT06568406 trial being conducted?
This trial is being conducted at Brno, Czechia.
Who is sponsoring the NCT06568406 clinical trial?
NCT06568406 is sponsored by Brno University Hospital. The principal investigator is Lukáš Hruban, PhD at University Hospital Brno, Czechia. The trial plans to enroll 250 participants.