Obstetric Anal Sphincter InjuryPFFNCT05832268
Pelvic Floor Function After Obstetric Injury to the Anal Sphincter
An observational study of Obstetric Anal Sphincter Injury and Anal Incontinence, run by Oslo University Hospital at 1 site in Norway.
Trial 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… 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, Anal Incontinence, Urinary Incontinence
- What is being tested?
- Obstetric Anal Sphincter Injury
- How many people
- 900 participants
- Where
- 1 siteNorway
- Study dates
- 19 Sep 2023to 1 Mar 2027
- How long will I take part?
- 1 Year
- 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
- Adult, Older adult
Study population: Study population will be women who had two or more vaginal deliveries at Oslo Universitetssykehus in the time period 2002-2018.
Who may be able to join
- 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
Who cannot join
- under 18 years
- consent incompetency
- Obstetric anal sphincter injury in subsequent pregnancies
- caesarian section in subsequent pregnancy
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
Official title: The Pelvic Floor Future Study
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:
Read more
- 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.
- Conditions
- Obstetric Anal Sphincter Injury, Anal Incontinence, Urinary Incontinence, Sexual Dysfunction
- Being tested
- Obstetric Anal Sphincter Injury
- Medical subject headings
- Encopresis, Urinary Incontinence, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric Anal Sphincter InjuryOther
We will investigate if a new vaginal delivery in those with a previous obstetric anal sphincter injury affects the function of anal musculature negatively
| Study group | Role | What they receive |
|---|---|---|
| Sphincter damage | Women who suffered an injury to anal sphincter after a vaginal delivery and had a subsequent delivery after this injury Receives: Other: Obstetric Anal Sphincter Injury | |
| Controls | Women who have had a at least two vaginal deliveries without suffering an injury to the anal sphincter Receives: Other: Obstetric Anal Sphincter Injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.
Number of participants with previous OASI who had a new vaginal delivery will be compared to participants with similar parity, without previous OASI. Differences in anal incontinence symptom score and quality of life will be measured by study questionnaires (St. Marks score, PFDI-20 and PFIQ-7).
Measured: 5- 20 years
Secondary outcomes (2)
Prevalence of urinary incontinence among women with previous OASI compared to women with similar parity without obstetric anal sphincter injury
Number of participants who report complaints about urinary incontinence, measured by study questionnaires (PFIQ-7, NFIR, PFDI-20).
Measured: 5-20 years
The risk of long- term dyspareunia and sexual dysfunction after previous obstetric anal sphincter injury compared to women with similar parity without obstetric anal sphincter injury.
Number of participants who report complaints about sexual dysfunction, the degree and type og dysfunction will be measured by study questionnaires (PISQ-12)
Measured: 5-20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start19 Sep 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Anal Sphincter InjuryStudies of the same condition, open and under way.
- More trials run by Oslo 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
- 900 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sissel Oversand, Oslo University Hospital
- Investigators
- Kristine A Kilaas, M.D, Study director, Oslo University HospitalRune Svenningsen, Ph.D, Study director, Oslo University HospitalSissel Oversand, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832268
- Sponsor's protocol ID
- 2019/654
- Acronym
- PFF
- Status last verified
- Oct 2023
- First submitted
- 22 Mar 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participant data will only be available to the researchers in charge of this project
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pelvic Floor Future Study
- ClinicalTrials.gov ID
- NCT05832268
- Acronym / sponsor ID
- PFF / 2019/654
- Conditions
- Obstetric Anal Sphincter Injury, Anal Incontinence, Urinary Incontinence, Sexual Dysfunction
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 27 Apr 2023 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sphincter damage | – | Other: Obstetric Anal Sphincter InjuryWomen who suffered an injury to anal sphincter after a vaginal delivery and had a subsequent delivery after this injury |
| Controls | – | Other: Obstetric Anal Sphincter InjuryWomen who have had a at least two vaginal deliveries without suffering an injury to the anal sphincter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Study population will be women who had two or more vaginal deliveries at Oslo Universitetssykehus in the time period 2002-2018.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- under 18 years
- consent incompetency
- Obstetric anal sphincter injury in subsequent pregnancies
- caesarian section in subsequent pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstetric Anal Sphincter InjuryWe will investigate if a new vaginal delivery in those with a previous obstetric anal sphincter injury affects the function of anal musculature negatively | Other | Controls, Sphincter damage |
Primary outcome
The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury.
Time frame: 5- 20 years
Number of participants with previous OASI who had a new vaginal delivery will be compared to participants with similar parity, without previous OASI. Differences in anal incontinence symptom score and quality of life will be measured by study questionnaires (St. Marks score, PFDI-20 and PFIQ-7).
2 secondary outcomes
Prevalence of urinary incontinence among women with previous OASI compared to women with similar parity without obstetric anal sphincter injury
Time frame: 5-20 years
The risk of long- term dyspareunia and sexual dysfunction after previous obstetric anal sphincter injury compared to women with similar parity without obstetric anal sphincter injury.
Time frame: 5-20 years
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 2 Nov 2023.
- Individual participant dataSharing planned: No. The participant data will only be available to the researchers in charge of this project
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Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
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Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland
Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries
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Improving Postpartum Quality of Life Through Enhanced Perineal Care Training
Postpartum Quality of Life, Peripartal Maternal Trauma
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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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.
Kristine A Kilaas, M.D study director
Oslo University Hospital
Rune Svenningsen, Ph.D study director
Oslo University Hospital
Sissel Oversand principal investigator
Oslo University Hospital
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 Anal Incontinence, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 4 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 2 Nov 2023. 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 Norway. 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?
The long-term impact of a new vaginal delivery on anal sphincter function in women with previous obstetric anal sphincter injury. (time frame: 5- 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2023.