Vaginal Birth After Caesarean Section and Levator Ani Avulsion

NCT ID: NCT03420001

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

469 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-02

Study Completion Date

2020-12-10

Brief Summary

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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

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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

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Birth Injuries

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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VBAC

secundiparous women after one vaginal birth after caesarean section

No interventions assigned to this group

controls

women after one vaginal delivery

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Zdenek Rusavy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Pilsen, , Czechia

Site Status

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

Prague, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 24311466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21985531 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21107811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18470963 (View on PubMed)

Other Identifiers

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10101010

Identifier Type: -

Identifier Source: org_study_id

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