Anal Sphincter InjuryNCT03039374
External Phase MRI in Diagnosis of OASI
An observational study of Anal Sphincter Injury and Obstetrics Trauma, run by University of Turku.
Trial summary
There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in Finland complicate in a Grade III- IV perineal tear. Because the diagnosis of a sphincter lesion after birth can be challenging the total amount of women having obtained a sphincter lesion could be even grater. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anal Sphincter Injury, Obstetrics Trauma
- What is being tested?
- Magnetic resonance imaging
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to 27 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients older than 18 and a 3rd or 4th degree perineal tear observed during birth meet the inclusion criteria. All women who have obtained such a injury during birth in the Vaasa or Seinäjoki Central hospitals will be evaluated for eligibility.
Who may be able to join
- Women with OASI
Who cannot join
- Under 18
About this study
Official title: The Use of External Phase Array MRI, 3D Endoanal Ultrasound, and Manometry in the Diagnosis of Obstetric Anal Sphincter Injuries
There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in Finland complicate in a Grade III- IV perineal tear. Because the diagnosis of a sphincter lesion after birth can be challenging the total amount of women having obtained a sphincter lesion could be even grater.
The aim of our study is to compare different tools in the diagnosis of obstetric anal sphincter injury. In doing so the investigators hope to achieve early diagnosis of this pathology and thus facilitate early treatment of a possible sphincter defect.
Read the detailed description
See the attacher research plan for a more detailed description
- Conditions
- Anal Sphincter Injury, Obstetrics Trauma
- Being tested
- Magnetic resonance imaging
- Keywords
- OASI, Faecal incontinence, Obstetric anal sphincter injury, MRI
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingOther
The extent of obstetric anal sphincter injury will be evaluated using MRI, endoanal ultrasound and anal manometry
| Study group | Role | What they receive |
|---|---|---|
| OASI patients | All patients older than 18 and a 3rd or 4th degree perineal tear during birth meet the inclusion criteria. All women who have obtained such a injury during birth in the Vaasa or Seinäjoki Central hospitals will be evaluated for eligibility. Receives: Other: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of MRI and endoanal ultrasound in diagnosis of obstetric anal sphincter injury
Comparison of anal sphincter characteristics (length, thickness at 3 and 9 o'clock) and placement of the possible rupture with both imaging modalities
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startSep 2014
- Primary completion20 Sep 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Sphincter InjuryStudies of the same condition, open and under way.
- 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Jaan Kirss, University of Turku
- Investigators
- Mikael Victorzon, prof., Study director, Professor of surgery Turku UniversityJaan Kirss, MD, Principal investigator, Resident in Gastroenterological surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039374
- Sponsor's protocol ID
- ISR-2014-10458
- Status last verified
- Oct 2017
- First submitted
- 30 Nov 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of External Phase Array MRI, 3D Endoanal Ultrasound, and Manometry in the Diagnosis of Obstetric Anal Sphincter Injuries
- ClinicalTrials.gov ID
- NCT03039374
- Acronym / sponsor ID
- ISR-2014-10458
- Conditions
- Anal Sphincter Injury, Obstetrics Trauma
- Keywords
- OASI, Faecal incontinence, Obstetric anal sphincter injury, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2014
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 1 Feb 2017 (estimated)
- 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.
There is around 60 000 births annually in Finland. Around 1-5% of all vaginal deliveries in Finland complicate in a Grade III- IV perineal tear. Because the diagnosis of a sphincter lesion after birth can be challenging the total amount of women having obtained a sphincter lesion could be even grater.
The aim of our study is to compare different tools in the diagnosis of obstetric anal sphincter injury. In doing so the investigators hope to achieve early diagnosis of this pathology and thus facilitate early treatment of a possible sphincter defect.
Detailed description
See the attacher research plan for a more detailed description
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OASI patients | – | Other: Magnetic resonance imagingAll patients older than 18 and a 3rd or 4th degree perineal tear during birth meet the inclusion criteria. All women who have obtained such a injury during birth in the Vaasa or Seinäjoki Central hospitals will be evaluated for eligibility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients older than 18 and a 3rd or 4th degree perineal tear observed during birth meet the inclusion criteria. All women who have obtained such a injury during birth in the Vaasa or Seinäjoki Central hospitals will be evaluated for eligibility.
Key inclusion criteria (1 listed)
- Women with OASI
Key exclusion criteria (1 listed)
- Under 18
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 |
|---|---|---|
| Magnetic resonance imagingThe extent of obstetric anal sphincter injury will be evaluated using MRI, endoanal ultrasound and anal manometry | Other | OASI patients |
Primary outcome
Comparison of MRI and endoanal ultrasound in diagnosis of obstetric anal sphincter injury
Time frame: 6 months to 1 year
Comparison of anal sphincter characteristics (length, thickness at 3 and 9 o'clock) and placement of the possible rupture with both imaging modalities
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Anal Sphincter Injury
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
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Active, not recruitingPhase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Fecal Incontinence
Enrolling by invitationObservational study
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
Recruiting
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
Pelvic Floor Dysfunction, Perineal Laceration
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. This study is not recruiting at the moment.
Mikael Victorzon, prof. study director
Professor of surgery Turku University
Jaan Kirss, MD principal investigator
Resident in Gastroenterological surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Sphincter Injury and Obstetrics Trauma, run by University of Turku.
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: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of MRI and endoanal ultrasound in diagnosis of obstetric anal sphincter injury (time frame: 6 months to 1 year). 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 6 Nov 2017.