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Birth InjuriesNCT03420001

Vaginal Birth After Caesarean Section and Levator Ani Avulsion

An observational study of Birth Injuries, run by Charles University, Czech Republic at 2 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Birth Injuries
How many people
469 participants
Where
2 sitesCzechia
Study dates
2 Aug 2017to 10 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Adult, Older adult

Study population: Women at least 6 months after the first vaginal delivery with or without a caesarean section in their history.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Czechia2 sites

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

    Pilsen, 30460

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

    Prague, 12808

Other trials in Czechia

About this study

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

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

Read the 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.

Conditions
Birth Injuries
Keywords
VBAC, levator ani avulsion, quality of life
Medical subject headings
Birth Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03420001
Study groupRoleWhat they receive
VBACsecundiparous women after one vaginal birth after caesarean section
controlswomen after one vaginal delivery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Levator ani avulsion

    Presence of levator ani avulsion diagnosed by offline tomographic ultrasound imaging of an ultrasound volume of the pelvic floor

    Measured: at least 6 months after the delivery

  2. Genital hiatus ballooning

    Area of the urogenital hiatus over 25cm2 during maximal Valsalva

    Measured: at least 6 months after the delivery

Secondary outcomes (3)

  1. 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)

    Measured: at time of the ultrasound examination

  2. 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.

    Measured: at time of the ultrasound examination

  3. 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.

    Measured: at time of the ultrasound examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2018
  2. Study start2 Aug 2017
  3. Primary completion30 Aug 2020
  4. Study completion10 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
469 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03420001
Sponsor's protocol ID
10101010
Status last verified
Aug 2021
First submitted
27 Jan 2018
Last updated
9 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24311466

  • 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.

    PubMed 21985531

  • 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.

    PubMed 21107811

  • 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.

    PubMed 18470963

Questions about this trial

What is this clinical trial studying?

An observational study of Birth Injuries, run by Charles University, Czech Republic at 2 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Levator ani avulsion (time frame: at least 6 months after the delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03420001, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.

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