Pelvic Floor Function After Obstetric Injury to the Anal Sphincter

NCT ID: NCT05832268

Last Updated: 2023-11-02

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

ENROLLING_BY_INVITATION

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-19

Study Completion Date

2027-03-01

Brief Summary

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The goal of this observational study is to learn more about the effect a pregnancy and delivery has on the function of the anal musculature.We will compare women who had a new delivery after suffering a severe tear in the anal musculature in their first pregnancy, with women who had two or more vaginal deliveries, but did not suffer such an injury.

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.

Detailed Description

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Conditions

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Obstetric Anal Sphincter Injury Anal Incontinence Urinary Incontinence Sexual Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Sphincter group: Previous obstetric anal sphincter injury during vaginal childbirth in 2002-2018 and having a subsequent vaginal delivery without such injury
* control group: Two or more vaginal deliveries without obstetric anal sphincter injury

Exclusion Criteria

* under 18 years
* consent incompetency
* Obstetric anal sphincter injury in subsequent pregnancies
* caesarian section in subsequent pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sissel Oversand

Principal investigator

Responsibility Role 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

Site Status

Countries

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Norway

Other Identifiers

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2019/654

Identifier Type: -

Identifier Source: org_study_id

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