Obstetric Anal Sphincter Injury3D_TV_OASISNCT06773520
Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation
An observational study of Obstetric Anal Sphincter Injury, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this observational study is to evaluate the reproducibility of new 3D/4D ultrasound volume analysis techniques in the assessment of anal sphincter integrity and thickness in both pregnancy and immediate postpartum. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Obstetric Anal Sphincter Injury
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 21 Nov 2023to 31 Aug 2027
- 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 to 44 years
- Women only
- No healthy volunteers
- Adult
Study population: Nulliparous and primiparous pregnant women. Participants will be enrolled at the Division of Obstetrics and Prenatal Age Medicine (IRCCS - Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola). Participants will be enrolled during the obstetrical visit or during hospitalization or during visits in the postpartum period.
Who may be able to join
- Pregnant nulliparous or primiparous women;
- Age between 18 and 44 years
- Acquisition of informed consent form
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD, 0512144412, aly.youssef@aosp.bo.it
About this study
Official title: Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation: "A New Technique"
The goal of this observational study is to evaluate the reproducibility of new 3D/4D ultrasound volume analysis techniques in the assessment of anal sphincter integrity and thickness in both pregnancy and immediate postpartum.
The negative impact that OASISs (Obstetric Anal Sphincter Injuries), and possible subsequent anal incontinence, have on women's quality of life has stimulated research in this field in recent decades. However, there are still few studies concerning the topic. The transperineal approach by means of the transvaginal probe in the study of the pelvic floor, anal sphincter and related lesions has helped us to make strides in our knowledge of the anatomy of the pelvic floor and in defining the lesions that may affect it.
Read the detailed description
The development of ultrasound techniques such as 3D and 4D and new reproducible and increasingly accurate volumetric acquisition modalities shows promise for improving the diagnosis of OASIS and the clinical management of OASIS and consequently the quality of life of women.
With new, simpler techniques of 3D/4D volume analysis of the anal sphincter, the number of operators able to objectively and accurately assess anal sphincter integrity, both in the delivery room and postpartum, could increase. The application and dissemination of an accurate and reproducible technique in the subjective assessment of the anal sphincter could help operators improve and refine the technique of surgical correction of anal sphincter injuries.
The primary objective of the study is to evaluate the reproducibility of novel 3D/4D ultrasound volume analysis techniques, using curvilinear reconstruction of the coronal plane of the anal sphincter combined with contrast enhancement technique (optic OMNIVIEW), in the assessment of anal sphincter integrity and thickness, both in pregnancy and immediate postpartum.
Secondary objectives include:
- Evaluation of the feasibility of new off-line analysis techniques.
- Evaluation of the correlation between thickness and ultrasound integrity of the anal sphincter at the postpartum visit and women's symptomatology in the postpartum.
To reduce bias as much as possible, each operator during each assessment will be "blinded" to the patient's history and all other measurements.
Clinicians who perform more than one measurement per volume will do so at least one month apart between each measurement.
The patient will be treated according to common clinical practice ensuring the standard of care. Patients will not undertake additional visits to those routinely performed. This is an evaluation of new techniques for off-line (in the absence of the patient) analysis of ultrasound volumes that are currently part of routine visits in both pre and postpartum.
- Conditions
- Obstetric Anal Sphincter Injury
- Keywords
- 3D untrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraclass correlation coefficient (ICC)
Bland-Altman analysis
Measured: At the end of pregnancy (up to 40 weeks of gestation)
Presence of a systematic difference between the various measures taken by different operators
Bland-Altman analysis
Measured: At the end of pregnancy (up to 40 weeks of gestation)
Dispersion of the differences between the measures taken by two different operators and the two measures taken by the same operator around the mean of the respective differences.
Bland-Altman analysis
Measured: At the end of pregnancy (up to 40 weeks of gestation)
Secondary outcomes (2)
Percentage of volumes acquired in which measurement of the external anal sphincter will be feasible
New analysis techniques: curvilinear reconstruction of the coronal plane of the anal sphincter combined with contrast enhancement technique.
Measured: At the end of pregnancy (up to 40 weeks of gestation)
Correlation between anal sphincter thickness and the presence of symptoms related to rectal incontinence
Comparison of anal sphincter thickness between women with and without exintent signs of rectal incontinence at postpartum visit
Measured: At the end of pregnancy (up to 40 weeks of gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start21 Nov 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 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 IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773520
- Sponsor's protocol ID
- 3D_TV_OASIS
- Acronym
- 3D_TV_OASIS
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Three-dimensional Transvaginal Ultrasound for Anal Sphincter Evaluation: "A New Technique"
- ClinicalTrials.gov ID
- NCT06773520
- Acronym / sponsor ID
- 3D_TV_OASIS / 3D_TV_OASIS
- Conditions
- Obstetric Anal Sphincter Injury
- Keywords
- 3D untrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 14 Jan 2025 (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 evaluate the reproducibility of new 3D/4D ultrasound volume analysis techniques in the assessment of anal sphincter integrity and thickness in both pregnancy and immediate postpartum.
The negative impact that OASISs (Obstetric Anal Sphincter Injuries), and possible subsequent anal incontinence, have on women's quality of life has stimulated research in this field in recent decades. However, there are still few studies concerning the topic. The transperineal approach by means of the transvaginal probe in the study of the pelvic floor, anal sphincter and related lesions has helped us to make strides in our knowledge of the anatomy of the pelvic floor and in defining the lesions that may affect it.
Detailed description
The development of ultrasound techniques such as 3D and 4D and new reproducible and increasingly accurate volumetric acquisition modalities shows promise for improving the diagnosis of OASIS and the clinical management of OASIS and consequently the quality of life of women.
With new, simpler techniques of 3D/4D volume analysis of the anal sphincter, the number of operators able to objectively and accurately assess anal sphincter integrity, both in the delivery room and postpartum, could increase. The application and dissemination of an accurate and reproducible technique in the subjective assessment of the anal sphincter could help operators improve and refine the technique of surgical correction of anal sphincter injuries.
The primary objective of the study is to evaluate the reproducibility of novel 3D/4D ultrasound volume analysis techniques, using curvilinear reconstruction of the coronal plane of the anal sphincter combined with contrast enhancement technique (optic OMNIVIEW), in the assessment of anal sphincter integrity and thickness, both in pregnancy and immediate postpartum.
Secondary objectives include:
- Evaluation of the feasibility of new off-line analysis techniques.
- Evaluation of the correlation between thickness and ultrasound integrity of the anal sphincter at the postpartum visit and women's symptomatology in the postpartum.
To reduce bias as much as possible, each operator during each assessment will be "blinded" to the patient's history and all other measurements.
Clinicians who perform more than one measurement per volume will do so at least one month apart between each measurement.
The patient will be treated according to common clinical practice ensuring the standard of care. Patients will not undertake additional visits to those routinely performed. This is an evaluation of new techniques for off-line (in the absence of the patient) analysis of ultrasound volumes that are currently part of routine visits in both pre and postpartum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Nulliparous and primiparous pregnant women. Participants will be enrolled at the Division of Obstetrics and Prenatal Age Medicine (IRCCS - Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola). Participants will be enrolled during the obstetrical visit or during hospitalization or during visits in the postpartum period.
Key inclusion criteria (3 listed)
- Pregnant nulliparous or primiparous women;
- Age between 18 and 44 years
- Acquisition of informed consent form
Key exclusion criteria (1 listed)
- None
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
Intraclass correlation coefficient (ICC)
Time frame: At the end of pregnancy (up to 40 weeks of gestation)
Bland-Altman analysis
Presence of a systematic difference between the various measures taken by different operators
Time frame: At the end of pregnancy (up to 40 weeks of gestation)
Bland-Altman analysis
Dispersion of the differences between the measures taken by two different operators and the two measures taken by the same operator around the mean of the respective differences.
Time frame: At the end of pregnancy (up to 40 weeks of gestation)
Bland-Altman analysis
2 secondary outcomes
Percentage of volumes acquired in which measurement of the external anal sphincter will be feasible
Time frame: At the end of pregnancy (up to 40 weeks of gestation)
Correlation between anal sphincter thickness and the presence of symptoms related to rectal incontinence
Time frame: At the end of pregnancy (up to 40 weeks of gestation)
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 14 Jan 2025.
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Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
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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.
Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 3 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: looking for participants now, as of the sponsor's last update on 14 Jan 2025. 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 Italy. 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?
Contact Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD (0512144412, aly.youssef@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraclass correlation coefficient (ICC) (time frame: At the end of pregnancy (up to 40 weeks of gestation)). The study lists 3 primary outcomes in all. 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 14 Jan 2025.