RecruitingNot ApplicableNCT06568406

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

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


Sponsor

Brno University Hospital

Enrollment

250 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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

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Interventions

PROCEDUREPhysiotherapy

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.

DIAGNOSTIC_TESTUrogynaecology

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).


Locations(1)

University Hospital

Brno, Czechia

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NCT06568406