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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05832268
Other study ID # 2019/654
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 19, 2023
Est. completion date March 1, 2027

Study information

Verified date October 2023
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 900
Est. completion date March 1, 2027
Est. primary completion date March 1, 2025
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
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

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury. Number of participants with previous OASI who had a new vaginal delivery will be compared to participants with similar parity, without previous OASI. Differences in anal incontinence symptom score and quality of life will be measured by study questionnaires (St. Marks score, PFDI-20 and PFIQ-7). 5- 20 years
Secondary Prevalence of urinary incontinence among women with previous OASI compared to women with similar parity without obstetric anal sphincter injury Number of participants who report complaints about urinary incontinence, measured by study questionnaires (PFIQ-7, NFIR, PFDI-20). 5-20 years
Secondary The risk of long- term dyspareunia and sexual dysfunction after previous obstetric anal sphincter injury compared to women with similar parity without obstetric anal sphincter injury. Number of participants who report complaints about sexual dysfunction, the degree and type og dysfunction will be measured by study questionnaires (PISQ-12) 5-20 years
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