Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568406
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Impact of Early Physiotherapy on Pain Quality of Life Pelvic Floor Function and Sexual Health Post-Episiotomy
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womans 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None