An observational study in Birth Injuries, sponsored by Charles University, Czech Republic. Completed at 2 sites in Czechia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-09.
Sponsored by Charles University, Czech Republic · Observational
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.
Women at least 6 months after the first vaginal delivery with or without a caesarean section in their history.
Exclusion Criteria:
secundiparous women after one vaginal birth after caesarean section
women after one vaginal delivery
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
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
Plan to share: Undecided
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Charles University, Czech Republic