Obstetric Anal Sphincter InjuryNCT04181840
Impedance Spectroscopy for Obstetric Anal Sphincter Injuries Detection
A study testing Blood and faeces tests, Impedance spectroscopy test and Full gynecological and proctological examination in people with Obstetric Anal Sphincter Injury and Delivery Complication, run by OASIS Diagnostics S.A. at 1 site in Poland.
Trial summary
The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in the detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises up to 56 patients; up to 16 weeks from a natural delivery. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Obstetric Anal Sphincter Injury, Delivery Complication, Obstetric Complication
- What is being tested?
- Blood and faeces tests, Impedance spectroscopy test and Full gynecological and proctological examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 sitePoland
- Study dates
- 15 Oct 2019to 20 Jul 2020
- Phase
- Interventional
- 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 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women patients,
- 18-49 years old,
- up to 16 weeks from a natural delivery
- with the presence of:
- clinically confirmed OASIS at least stage II, as a result of an episiotomy or uncontrolled crotch rupture (in patients with crotch protection), or
- at least one risk factor, such as:
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- the extended second delivery phase,
- instrumental delivery (vacuum or forceps),
- shoulder dystocia,
- birth weight of the child > 4kg,
- episiotomy,
- uncontrolled perineal laceration (in patients with crotch protection),
- induction of delivery using oxytocin,
- head circumference ≥34 mm and other.
- the patient's understanding of the nature of the clinical study and permission in writing from the patient to participate in this study.
Who cannot join
- the presence of acute diseases during treatment,
- the presence of chronic diseases not treated or treated insufficiently (e.g., incorrectly controlled hypertension),
- the presence of diseases with accompanying symptoms of fecal incontinence history of proctology surgery's whit postoperative complication,
- the presence of inflammatory bowel diseases during the exacerbation phase,
- the treatment in the last year because of serious, progressive, uncontrolled cardiological, pulmonary, nephrology, contagious or psychiatric illness whose course could affect the patient's risk increase due to participation in the study,
- significant disease symptoms so far undiagnosed,
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- the presence or suspected malignant disease or previous on previous oncological treatment in the last 5 years,
- the presence of a cardiac stimulator or cardioverter-defibrillator,
- severe surgery or severe trauma in the last year.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Praktyka Lekarska Małgorzata Uchman-Musielak
Warsaw, Masovian Voivodeship, 05-077
About this study
Official title: Impedance Spectroscopy Using the ONIRY Device in the Diagnosis of Sphincter Injuries in Women After Vaginal Deliveries
The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in the detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises up to 56 patients; up to 16 weeks from a natural delivery. The planned participation of each patient in the study is up to 4 weeks and two visits will take place at that time.
After obtaining written consent, at the first visit (V1) each patient will undergo a physical examination (both proctological and gynecological examination), blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected. The presence of clinical symptoms of both gas and stool incontinence will be assessed during the visit with the use of Wexner's scale. Then, the dates of two reference tests will be planned: Trans-rectal USG and Recto-anal manometry which will be performed as part of the V1 visit within a period not exceeding 27 days.
Read more
The V2 visit, which will also be the final visit, will include a reassessment of the patient's general condition, recording the values of basic vital parameters, subjective and physical examination, and then the doctor conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter.
During the visits, all adverse events will also be monitored, both those reported by patients and those related to the examined diagnostic device.
- Being tested
- Blood and faeces tests, Impedance spectroscopy test, Full gynecological and proctological examination, Transanal ultrasonography, Anorectal manometry
- Keywords
- Obstetric Anal Sphincter Injury, Impedance Spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and faeces testsDiagnostic test
During V1 - Laboratory tests, particularly for calprotectin concentration assessment
Impedance spectroscopy testDevice
During V1 - the electrical impedance of anal sphincter muscles will be measured
Full gynecological and proctological examinationDiagnostic test
During V1 and V2 - Examination with a gynecological speculum, Two-handed examination, Rectal examination, and Anoscopy
Transanal ultrasonographyDiagnostic test
During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
Anorectal manometryDiagnostic test
During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
Determining the degree of sphincter injuryOther
During V2 - conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter.
| Study group | Role | What they receive |
|---|---|---|
| Impedance spectroscopy | Experimental | Maximum 56 women up to 16 weeks from a natural delivery, with at least one perinatal anal sphincter injury risk factor, such as: the extended second delivery phase, instrumental delivery (vacuum or forceps), shoulder dystocia, birth weight of the child > 4kg, episiotomy, uncontrolled perineal laceration (in patients with crotch protection).
The planned interventions are:
* Blood and faeces tests
* Impedance spectroscopy test
* Full gynecological and proctological examination
* Transanal ultrasonography
* Anorectal manometry Receives: Diagnostic Test: Blood and faeces tests; Device: Impedance spectroscopy test; Diagnostic Test: Full gynecological and proctological examination; Diagnostic Test: Transanal ultrasonography; Diagnostic Test: Anorectal manometry; Other: Determining the degree of sphincter injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anal sphincters continuity (injuries) assessed in physical examination and trancanal ultrasonography
Assessment using:
- OASIS classification of perineal tears.
- Starck scale (0-16 scale, no defect - 0, maximum - 16, which means severe damage of both sphincters on a considerable length and circumference).
- Norderval scale (0-7 scale, no defect - 0, 7 is the maximal damage of both anal sphincters).
Measured: 16 weeks
Anal sphincter tension (function) assessed in physical examination and anorectal manometry
Measured: 16 weeks
Anal sphincter assessment evaluated by impedance spectroscopy
Estimation of the presence, extent and severity of anal sphincter injury, by impedance moduli and phase shifts.
The main aim of the study is to establish whether the extension and severity of obstetric anal sphincter injury can be precisely assessed with parameters calculated from anal sphincter muscles using impedance spectroscopy.
Measured: 16 weeks
Secondary outcomes (1)
Adverse events
Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start15 Oct 2019
- Primary completion26 Jun 2020
- Study completion20 Jul 2020
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- OASIS Diagnostics S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Małgorzata Uchman-Musielak, MD, PhD, Principal investigator, Specialist Medical Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181840
- Sponsor's protocol ID
- 2/1/2019 (May 6)
- Status last verified
- Sep 2020
- First submitted
- 21 Nov 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impedance Spectroscopy Using the ONIRY Device in the Diagnosis of Sphincter Injuries in Women After Vaginal Deliveries
- ClinicalTrials.gov ID
- NCT04181840
- Acronym / sponsor ID
- 2/1/2019 (May 6)
- Keywords
- Obstetric Anal Sphincter Injury, Impedance Spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- OASIS Diagnostics S.A.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 2 Dec 2019 (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 main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in the detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises up to 56 patients; up to 16 weeks from a natural delivery. The planned participation of each patient in the study is up to 4 weeks and two visits will take place at that time.
After obtaining written consent, at the first visit (V1) each patient will undergo a physical examination (both proctological and gynecological examination), blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected. The presence of clinical symptoms of both gas and stool incontinence will be assessed during the visit with the use of Wexner's scale. Then, the dates of two reference tests will be planned: Trans-rectal USG and Recto-anal manometry which will be performed as part of the V1 visit within a period not exceeding 27 days.
The V2 visit, which will also be the final visit, will include a reassessment of the patient's general condition, recording the values of basic vital parameters, subjective and physical examination, and then the doctor conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter.
During the visits, all adverse events will also be monitored, both those reported by patients and those related to the examined diagnostic device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impedance spectroscopy | Experimental | Diagnostic Test: Blood and faeces tests, Device: Impedance spectroscopy test, Diagnostic Test: Full gynecological and proctological examination, Diagnostic Test: Transanal ultrasonography, Diagnostic Test: Anorectal manometry, Other: Determining the degree of sphincter injuryMaximum 56 women up to 16 weeks from a natural delivery, with at least one perinatal anal sphincter injury risk factor, such as: the extended second delivery phase, instrumental delivery (vacuum or forceps), shoulder dystocia, birth weight of the child > 4kg, episiotomy, uncontrolled perineal laceration (in patients with crotch protection). The planned interventions are: * Blood and faeces tests * Impedance spectroscopy test * Full gynecological and proctological examination * Transanal ultrasonography * Anorectal manometry |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- women patients,
- 18-49 years old,
- up to 16 weeks from a natural delivery
- with the presence of:
- the extended second delivery phase,
Key exclusion criteria (9 listed)
- the presence of acute diseases during treatment,
- the presence of chronic diseases not treated or treated insufficiently (e.g., incorrectly controlled hypertension),
- the presence of diseases with accompanying symptoms of fecal incontinence history of proctology surgery's whit postoperative complication,
- the presence of inflammatory bowel diseases during the exacerbation phase,
- the treatment in the last year because of serious, progressive, uncontrolled cardiological, pulmonary, nephrology, contagious or psychiatric illness whose course could affect the patient's risk increase due to participation in the study,
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 |
|---|---|---|
| Blood and faeces testsDuring V1 - Laboratory tests, particularly for calprotectin concentration assessment | Diagnostic test | Impedance spectroscopy |
| Impedance spectroscopy testDuring V1 - the electrical impedance of anal sphincter muscles will be measured | Device | Impedance spectroscopy |
| Full gynecological and proctological examinationDuring V1 and V2 - Examination with a gynecological speculum, Two-handed examination, Rectal examination, and Anoscopy | Diagnostic test | Impedance spectroscopy |
| Transanal ultrasonographyDuring V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results. | Diagnostic test | Impedance spectroscopy |
| Anorectal manometryDuring V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results. | Diagnostic test | Impedance spectroscopy |
| Determining the degree of sphincter injuryDuring V2 - conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter. | Other | Impedance spectroscopy |
Primary outcome
Anal sphincters continuity (injuries) assessed in physical examination and trancanal ultrasonography
Time frame: 16 weeks
Assessment using: 1. OASIS classification of perineal tears. 2. Starck scale (0-16 scale, no defect - 0, maximum - 16, which means severe damage of both sphincters on a considerable length and circumference). 3. Norderval scale (0-7 scale, no defect - 0, 7 is the maximal damage of both anal sphincters).
Anal sphincter tension (function) assessed in physical examination and anorectal manometry
Time frame: 16 weeks
Anal sphincter assessment evaluated by impedance spectroscopy
Time frame: 16 weeks
Estimation of the presence, extent and severity of anal sphincter injury, by impedance moduli and phase shifts. The main aim of the study is to establish whether the extension and severity of obstetric anal sphincter injury can be precisely assessed with parameters calculated from anal sphincter muscles using impedance spectroscopy.
1 secondary outcome
Adverse events
Time frame: 16 weeks
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 16 Sep 2020.
- Sponsor's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
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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
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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
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.
Małgorzata Uchman-Musielak, MD, PhD principal investigator
Specialist Medical Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and faeces tests, Impedance spectroscopy test and Full gynecological and proctological examination in people with Obstetric Anal Sphincter Injury and Delivery Complication, run by OASIS Diagnostics S.A. at 1 site in Poland.
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 15 inclusion and 9 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 16 Sep 2020. 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 Poland. 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?
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?
Anal sphincters continuity (injuries) assessed in physical examination and trancanal ultrasonography (time frame: 16 weeks). 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 16 Sep 2020.