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Completed

NCT Number: NCT03420001

Vaginal Birth After Caesarean Section and Levator Ani Avulsion

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

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Key information

Conditions

Birth Injuries Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Levator ani avulsion

    Time frame: 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

  2. Genital hiatus ballooning

    Time frame: at least 6 months after the delivery

    Area of the urogenital hiatus over 25cm2 during maximal Valsalva

Secondary outcomes

  1. Pelvic floor dysfunction

    Time frame: 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)

  2. Anal incontinence

    Time frame: 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.

  3. Sexuality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2018
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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