Vaginal Birth After Caesarean Section and Levator Ani Avulsion

NCT03420001 | Completed

• 1 other identifier: 10101010
• Study Type: observational
• Target: 469
• Locations: 1 country
• Sites: 2

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

Conditions

Birth Injuries

Keywords

VBAC, levator ani avulsion, quality of life

Outcome Measures

Primary Outcomes (2)

• 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

• Genital hiatus ballooning

  Area of the urogenital hiatus over 25cm2 during maximal Valsalva

  at least 6 months after the delivery

Secondary Outcomes (3)

• Pelvic floor dysfunction

  at time of the ultrasound examination

• Anal incontinence

  at time of the ultrasound examination

• Sexuality

  at time of the ultrasound examination

Study Arms (2)

VBAC

secundiparous women after one vaginal birth after caesarean section

controls

women after one vaginal delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• one term vaginal delivery in obstetric history
• agreement with the enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (2)

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

Pilsen, 30460, Czechia

Location

Department of Obstetrics and Gynecology, 1st Medical Faculty, Charles University Hospital

Prague, 12808, Czechia

Location

Related Publications (4)

• 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.

  PMID: 24311466 BACKGROUND

• 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.

  PMID: 21985531 BACKGROUND

• 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.

  PMID: 21107811 BACKGROUND

• 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.

  PMID: 18470963 BACKGROUND

MeSH Terms

Conditions

Birth Injuries

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2018
• First Posted: February 5, 2018
• Study Start: August 2, 2017
• Primary Completion: August 30, 2020
• Study Completion: December 10, 2020
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

CZ (2)