Obstetric Anal Sphincter InjuryNCT07646340
Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland
An observational study of Obstetric Anal Sphincter Injury and Sexual Dysfunction and the Mode of Deliveries, run by Tampere University Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries, Pelvic Floor Disorders
- How many people
- 600 participants
- Where
- 1 siteFinland
- Study dates
- 9 Oct 2026to 31 Jul 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- Obstetric anal sphincter injury in Tampere University Hospital during 2009-2021
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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?
Read more
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
- Conditions
- Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries, Pelvic Floor Disorders
- Keywords
- obstetric anal sphincter injury, sexual dysfunction, vaginal delivery, pelvic floor symptoms
- Medical subject headings
- Sexual Dysfunction, Physiological, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5-26 years after the delivery complicated by OASI
Secondary outcomes (1)
Satisfaction regarding the choice of mode of delivery in subsequent delivery
Satisfaction assessed with a numerical rating scale (1 to 10)
Measured: 5-26 years after the delivery complicated by OASI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start9 Oct 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetric Anal Sphincter InjuryStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646340
- Sponsor's protocol ID
- R26016
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Finnish legislation prohibits sharing individual participant data.
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.
PubMed 40684100
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland
- ClinicalTrials.gov ID
- NCT07646340
- Acronym / sponsor ID
- R26016
- Conditions
- Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries, Pelvic Floor Disorders
- Keywords
- obstetric anal sphincter injury, sexual dysfunction, vaginal delivery, pelvic floor symptoms
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 9 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (1 listed)
- Obstetric anal sphincter injury in Tampere University Hospital during 2009-2021
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pelvic floor symptoms
Time frame: 5-26 years after the delivery complicated by OASI
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.
Sexual dysfunction
Time frame: 5-26 years after the delivery complicated by OASI
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.
1 secondary outcome
Satisfaction regarding the choice of mode of delivery in subsequent delivery
Time frame: 5-26 years after the delivery complicated by OASI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 40684100Ristila 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.
- Individual participant dataSharing planned: No. Finnish legislation prohibits sharing individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Anal Sphincter Injury and Sexual Dysfunction and the Mode of Deliveries, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor symptoms (time frame: 5-26 years after the delivery complicated by OASI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07646340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.