Clinical trial NCT03420001: Vaginal Birth After Caesarean Section and Levator Ani Avulsion
Official title: Do Women With Vaginal Birth After Caesarean Section Have an Increased Risk of Levator Avulsion?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birth Injuries
Keywords: VBAC, levator ani avulsion, quality of life
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 469
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women at least 6 months after the first vaginal delivery with or without a caesarean section in their history.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Levator ani avulsion
timeFrame: at least 6 months after the delivery
measure: Genital hiatus ballooning
timeFrame: at least 6 months after the delivery
Secondary outcomes:
measure: Pelvic floor dysfunction
timeFrame: at time of the ultrasound examination
measure: Anal incontinence
timeFrame: at time of the ultrasound examination
measure: Sexuality
timeFrame: at time of the ultrasound examination
Other outcomes:
Locations:
city: Pilsen
country: Czechia
facility: Department of Obstetrics and Gynecology, Medical Faculty in Pilsen, Charles University Hospital
city: Prague
country: Czechia
facility: Department of Obstetrics and Gynecology, 1st Medical Faculty, Charles University Hospital
Study officials:
References:
citation: Horak TA, Guzman-Rojas RA, Shek KL, Dietz HP. Pelvic floor trauma: does the second baby matter? Ultrasound Obstet Gynecol. 2014 Jul;44(1):90-4. doi: 10.1002/uog.13252. Epub 2014 May 23.
citation: Albrich SB, Laterza RM, Skala C, Salvatore S, Koelbl H, Naumann G. Impact of mode of delivery on levator morphology: a prospective observational study with three-dimensional ultrasound early in the postpartum period. BJOG. 2012 Jan;119(1):51-60. doi: 10.1111/j.1471-0528.2011.03152.x. Epub 2011 Oct 10.
citation: Dietz HP, Bernardo MJ, Kirby A, Shek KL. Minimal criteria for the diagnosis of avulsion of the puborectalis muscle by tomographic ultrasound. Int Urogynecol J. 2011 Jun;22(6):699-704. doi: 10.1007/s00192-010-1329-4. Epub 2010 Nov 24.
citation: Dietz HP, Shek C, De Leon J, Steensma AB. Ballooning of the levator hiatus. Ultrasound Obstet Gynecol. 2008 Jun;31(6):676-80. doi: 10.1002/uog.5355.