Vaginal Birth After Caesarean Section and Levator Ani Avulsion

Birth Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420001
• Other study ID #: 10101010
• Status: Completed
• Start date: August 2, 2017
• Est. completion date: December 10, 2020

Study information

• Verified date: August 2021
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 469
• Est. completion date: December 10, 2020
• Est. primary completion date: August 30, 2020
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Injuries

Locations

Country	Name	City	State
Czechia	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

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levator ani avulsion	Presence of levator ani avulsion diagnosed by offline tomographic ultrasound imaging of an ultrasound volume of the pelvic floor	at least 6 months after the delivery
Primary	Genital hiatus ballooning	Area of the urogenital hiatus over 25cm2 during maximal Valsalva	at least 6 months after the delivery
Secondary	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)	at time of the ultrasound examination
Secondary	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.	at time of the ultrasound examination
Secondary	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.	at time of the ultrasound examination