Vaginal Birth After Caesarean Section and Levator Ani Avulsion

Completed

• Conditions: Birth Injuries

• Registration Number: NCT03420001
• Lead Sponsor: Charles University, Czech Republic

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.

Study Timeline

• Study Start: 2017-08-02
• Study First Submitted: 2018-01-27
• Study First Submitted QC: 2018-01-27
• Study First Posted: 2018-02-05
• Primary Completion: 2020-08-30
• Study Completion: 2020-12-10
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 469

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pelvic floor dysfunction	at time of the ultrasound examination	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)
Anal incontinence	at time of the ultrasound examination	Scoring of the severity of anal incontinence using the St. Mark's score - scoring system (0 - perfect continence, maximum score 24 - totally incontienent.
Sexuality	at time of the ultrasound examination	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.

Trial Locations

Locations (2)

Department of Obstetrics and Gynecology, Medical Faculty in Pilsen, Charles University Hospital; 🇨🇿 Pilsen, Czechia

Department of Obstetrics and Gynecology, 1st Medical Faculty, Charles University Hospital; 🇨🇿 Prague, Czechia