Vaginal Birth After Caesarean Section and Levator Ani Avulsion

Study Overview
=================
Brief Summary
-----------------
There is no data regarding the risk of levator ani avulsion in women after a vaginal birth after caesarean although a possible increased risk has been suggested. The aim of the study is to describe the incidence of levator ani avulsion and compare it to primiparous women. In addition, health related quality of life will be evaluated and compared

Detailed Description
-----------------
Levator ani muscle avulsion is a frequent postpartum trauma imposing a considerable risk of pelvic organ prolapse on women in later life. Furthermore, the trauma reduces the effectiveness of pelvic reconstructive surgery and has a detrimental effect of the sexuality of the affected women. The trauma occurs most frequently in the first vaginal delivery with an incidence of 10-30%. However, the risk of levator avulsion in women after vaginal birth after caesarean section (VBAC) is unknown although possible increased risk has been suggested. The aim of the study is to assess the prevalence of levator ani avulsion among women who delivered vaginally after a caesarean section and make a comparison with a primiparous cohort. The secondary aim is to evaluate and compare the health related quality of life regarding pelvic floor disorders and sexuality.

Official Title
-----------------
Do Women With Vaginal Birth After Caesarean Section Have an Increased Risk of Levator Avulsion?

Conditions
-----------------
Birth Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: one term vaginal delivery in obstetric history agreement with the enrollment Exclusion Criteria: Women with a history of repeat VBAC or a vaginal delivery prior to the index caesarean section women with preterm labor epidural analgesia multiple pregnancy dead or malformed fetus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VBAC<br>secundiparous women after one vaginal birth after caesarean section | |
| controls<br>women after one vaginal delivery | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levator ani avulsion | Presence of levator ani avulsion diagnosed by offline tomographic ultrasound imaging of an ultrasound volume of the pelvic floor | at least 6 months after the delivery | 
| Genital hiatus ballooning | Area of the urogenital hiatus over 25cm2 during maximal Valsalva | at least 6 months after the delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic floor dysfunction | Pelvic Floor Distress Inventory - PFDI-20 - shortened form of a validated questionnaire evaluating quality of life with pelvic floor disorders (pelvic organ prolapse, urinary incontinence, anal incontinence) evaluation of subscales POPDI-6, UDI-6, CRADI-8 (scale 0-100 in all subscales, the higher the number the higher the impact) | at time of the ultrasound examination | 
| Anal incontinence | Scoring of the severity of anal incontinence using the St. Mark's score - scoring system (0 - perfect continence, maximum score 24 - totally incontienent. | at time of the ultrasound examination | 
| Sexuality | Evaluation of sexuality using validated Czech translation of the Pelvic Organ Prolapseand incontinence sexual questionnaire - internationally revised (PISQ-IR) - analysis of individual domains via subscores (NSA-CS, NSA-PR, NSA-GQ, NSA-CI or SA-AO, SA-PR, SA-CS, SA-GQ, SA-D, SA-CI. Transformed score 0-100 for each subscore. | at time of the ultrasound examination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VBAC, levator ani avulsion, quality of life