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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No subsequent deliveries | No pregnancies ending in delivery after obstetric anal sphincter injury | ||
| Subsequent cesarean delivery | Only cesarean delivery/deliveries after obstetric anal sphincter injury | ||
| Subsequent vaginal delivery | Vaginal delivery/deliveries after obstetric anal sphincter injury |
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| Measure | Description | Time Frame |
|---|---|---|
| Pelvic floor symptoms | Pelvic floor symptoms described in the short form of PFDI-20 (Pelvic floor distress inventory) questionnaire. The questionnaire consists of 20 items, each of which is scored from 0 to 4 points. The items are presented in domains describing different pelvic floor symptoms: those associated with pelvic organ prolapse, those associated with defecation, and urinary symptoms. Higher score indicates more distress associated with the symptom. In this study, individual items, domain scores and overall score are compared between the study groups. | 5-26 years after the delivery complicated by OASI |
| Sexual dysfunction | Sexual dysfunction symptoms described in the PISQ-12 (Pelvic organ prolapse/urinary incontinense sexual questionnaire). This instrument includes 12 items that are scored on a scale from 1 to 5, higher score indicating higher sexual function. In this study, each item score as well as total score will be compared between the groups. | 5-26 years after the delivery complicated by OASI |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction regarding the choice of mode of delivery in subsequent delivery | Satisfaction assessed with a numerical rating scale (1 to 10) | 5-26 years after the delivery complicated by OASI |
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Inclusion Criteria:
Exclusion Criteria:
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The study population consists of individuals who gave birth at Tampere University Hospital (Tays) between 2009 and 2021 and whose delivery was complicated by an anal sphincter injury (n = 580).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40684100 | Background | 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. |
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Finnish legislation prohibits sharing individual participant data.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 26, 2026 | Jun 8, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |