By InvitationNot Applicable

Pelvic Floor Function After Obstetric Injury to the Anal Sphincter

Norway900 participantsStarted 2023-09-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.

Timeframe: 5- 20 years

Trial details

NCT IDNCT05832268

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-01

View on ClinicalTrials.gov More Obstetric Anal Sphincter Injury trials