Pelvic Floor Function After Obstetric Injury to the Anal Sphincter
NCT ID: NCT05832268
Last Updated: 2023-11-02
Study Results
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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ENROLLING_BY_INVITATION
900 participants
OBSERVATIONAL
2023-09-19
2027-03-01
Brief Summary
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The main questions we want to answer is:
* can the burden of a new pregnancy and delivery weaken the function of the repaired musculature in a way that might cause symptoms of anal incontinence later in life?
* can a tear in the anal musculature increase the risk of developing urinary incontinence and long term sexual dysfunction?
* should we recommend these women to have a caesarian section instead of a new vaginal delivery?
Participants will be asked to complete an electronic questionnaire with information regarding their pregnancies, deliveries and potential symptoms from anal incontinence, urinary incontinence and sexual dysfunction.
Researchers will compare these two groups to find out if a new vaginal delivery has a negative effect on the function of the anal musculature.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sphincter damage
Women who suffered an injury to anal sphincter after a vaginal delivery and had a subsequent delivery after this injury
Obstetric Anal Sphincter Injury
We will investigate if a new vaginal delivery in those with a previous obstetric anal sphincter injury affects the function of anal musculature negatively
Controls
Women who have had a at least two vaginal deliveries without suffering an injury to the anal sphincter
Obstetric Anal Sphincter Injury
We will investigate if a new vaginal delivery in those with a previous obstetric anal sphincter injury affects the function of anal musculature negatively
Interventions
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Obstetric Anal Sphincter Injury
We will investigate if a new vaginal delivery in those with a previous obstetric anal sphincter injury affects the function of anal musculature negatively
Eligibility Criteria
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Inclusion Criteria
* control group: Two or more vaginal deliveries without obstetric anal sphincter injury
Exclusion Criteria
* consent incompetency
* Obstetric anal sphincter injury in subsequent pregnancies
* caesarian section in subsequent pregnancy
18 Years
FEMALE
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Sissel Oversand
Principal investigator
Principal Investigators
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Kristine A Kilaas, M.D
Role: STUDY_DIRECTOR
Oslo University Hospital
Rune Svenningsen, Ph.D
Role: STUDY_DIRECTOR
Oslo University Hospital
Sissel Oversand
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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Other Identifiers
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2019/654
Identifier Type: -
Identifier Source: org_study_id
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