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NCT05832268: PFF
Pelvic Floor Function After Obstetric Injury to the Anal Sphincter
trial testing Obstetric Anal Sphincter Injury in Obstetric Anal Sphincter Injury in 900 participants. Enrolling by invitation.
1 March 2025
Quick facts
| Lead sponsor | Oslo University Hospital |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 900 |
| Start date | 19 September 2023 |
| Primary completion | 1 March 2025 |
| Estimated completion | 1 March 2027 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- Obstetric Anal Sphincter Injury
Conditions studied
- Obstetric Anal Sphincter Injury — all drugs for Obstetric Anal Sphincter Injury →
- Anal Incontinence — all drugs for Anal Incontinence →
- Urinary Incontinence — all drugs for Urinary Incontinence →
- Sexual Dysfunction — all drugs for Sexual Dysfunction →
Sponsor
Oslo University Hospital
Who can join
18 and older, female only, with Obstetric Anal Sphincter Injury or Anal Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05832268
- Europe PMC full search
- ASCO Meeting Library
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Related trials
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Other Oslo University Hospital trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05832268 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Oslo University Hospital
- Last refreshed: 2 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05832268.
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