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Enrolling by invitation NCT07646340

Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland

Observational Obstetric Anal Sphincter Injury Sexual Dysfunction and the Mode of Deliveries Pelvic Floor Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries, Pelvic Floor Disorders. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this observational study is to understand long-term pelvic floor symptoms and sexual dysfunction after childbirth-related anal sphincter injury in women who gave birth at Tampere University Hospital between 2009 and 2021. The main questions it aims to answer are: How common are long-term pelvic floor symptoms and sexual dysfunction after sphincter injury? What factors are associated with an increased risk of long-term symptoms? Additionally, the study explores whether sphincter injury affects desired family size and satisfaction with the mode of delivery in a subsequent pregnancy. Participants will: * Receive an information letter, consent form, and questionnaires by mail. They can respond via mail or complete them electronically via a secure online service * Complete questionnaires on pelvic floor symptoms (PFDI-20), sexual function (PISQ-12), and preferences regarding childbirth and family size * Allow researchers to use their medical record data related to pregnancy, childbirth, postpartum period, and newborn outcomes for research purposes

Primary outcome measures

  • Pelvic floor symptoms [Time frame: 5-26 years after the delivery complicated by OASI]
  • Sexual dysfunction [Time frame: 5-26 years after the delivery complicated by OASI]
Secondary outcome measures (1)
  • Satisfaction regarding the choice of mode of delivery in subsequent delivery [Time frame: 5-26 years after the delivery complicated by OASI]

Eligibility criteria

Inclusion criteria

  • Obstetric anal sphincter injury in Tampere University Hospital during 2009-2021

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Finland · 1 center
  • Tampere University Hospital — Tampere

Publications

  • Ristila E, Palomaki O, Huhtala H, Toivonen E. Mode of delivery and maternal outcome in subsequent delivery after an obstetric anal sphincter injury: a Finnish retrospective cohort study. BMC Pregnancy Childbirth. 2025 Jul 19;25(1):773. doi: 10.1186/s12884-025-07882-9. PMID 40684100

Identifiers

NCT: NCT07646340 · R26016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗