Vaginal Birth After Caesarean Section and Levator Ani Avulsion

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03420001

Enrollment

469

Registered

2018-02-05

Start date

2017-08-02

Completion date

2020-12-10

Last updated

2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Injuries

Keywords

VBAC, levator ani avulsion, quality of life

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Czechia

Outcome results