Vaginal Birth After Caesarean Section and Levator Ani Avulsion

N/ACompletedNCT03420001

Charles University, Czech Republic469 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

469

Conditions

Birth Injuries

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Levator ani avulsion

Presence of levator ani avulsion diagnosed by offline tomographic ultrasound imaging of an ultrasound volume of the pelvic floor

Time frame: at least 6 months after the delivery

Genital hiatus ballooning

Area of the urogenital hiatus over 25cm2 during maximal Valsalva

Time frame: at least 6 months after the delivery

Secondary Outcomes

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)

Time frame: 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.

Time frame: 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.

Time frame: at time of the ultrasound examination

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.