Obstetric Anal Sphincter InjuryNCT03769792
Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries
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, Obstetric, 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 detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises 24 patients; included in it 6-8 weeks after 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, Obstetric
- 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
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 4 Feb 2019to 23 Dec 2019
- 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
- after natural delivery and post-partum period (6-8 weeks after delivery)
- physiological pregnancy
- observed a perianal tear of grade 1-4 in the OASIS classification
- signed informed consent
Who cannot join
- presence of acute diseases during treatment
- presence of chronic diseases untreated or insufficiently treated (e.g. poorly controlled hypertension),
- presence of diseases, with symptoms of fecal incontinence,
- previous proctological operations,
- the presence of inflammatory bowel diseases in the stage of exacerbation,
- treatment in the last year due to severe, progressive, uncontrolled cardiac, pulmonary, nephrological, infectious or psychiatric disease, which course could affect the patient's risk due to participation in study,
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- significant deviations from the norm in a physical examination during V0 visit or laboratory tests taken during the same visit,
- significant disease symptoms so far undiagnosed and reported during the V0 visit
- presence or suspected malignant disease or previous oncological treatment during the last 5 years,
- 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.
About this study
Official title: Evaluation of the Effectiveness and Safety of Impedance Spectroscopy Device in Detecting Sphincter Injuries in Women After Natural Delivery
The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises 24 patients; included in it 6-8 weeks after natural delivery. The planned participation of each patient in the study is up to 4 weeks and three visits will take place at that time.
After obtaining written consent, at the screening visit (V0) each patient will undergo a physical examination, blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected.
Read more
On the second visit (V1), after the final verification of inclusion/exclusion criteria, impedance spectroscopy using tested device will be performed in each patient, the electrical impedance of pelvic floor muscles will be measured and the degree of anal sphincter damage will be evaluated. Full gynecological and proctological examination (including a gynecological speculum, two-handed examination, rectal examination and anoscopy) will be carried out.
On the third visit (V2), two reference diagnostic tests (with evidenced effectiveness and safety), transanal ultrasonography and anorectal manometry, will be conducted. The collected data will be used to select the optimal therapeutic method for each participant individually.
- Being tested
- Blood and faeces tests, Impedance spectroscopy test, Full gynecological and proctological examination, Transanal ultrasonography, Anorectal manometry
- Keywords
- Obstetrical 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 V0 - Laboratory tests, particularly for calprotectin concentration assessment
Impedance spectroscopy testDevice
During V1 - the electrical impedance of pelvic floor muscles will be measured
Full gynecological and proctological examinationDiagnostic test
During V1 - Examination with a gynecological speculum, Two-handed examination, Rectal examination and Anoscopy
Transanal ultrasonographyDiagnostic test
During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
Anorectal manometryDiagnostic test
During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
| Study group | Role | What they receive |
|---|---|---|
| Impedance spectroscopy | Experimental | 24 women will be included in the study and divided into two subgroups.
12 of them (first subgroup) came from patients within 6 to 8 weeks after natural delivery, that had a perianal tear of grade 1 or 2 in OASIS classification.
Remaining 12 (second subgroup) came from patients within 6 to 8 weeks after natural delivery, that had a perianal tear of grade 3 or 4 in OASIS classification.
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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anal sphincters injury
Assessed by subsequent measures:
- Sphincter continuity in physical examination,
- Sphincter tension in physical examination,
- OASIS classification of perineal tears in transanal ultrasonography
- Starck scale for classification of anal sphincter injuries in transanal ultrasound (0-16 scale, no defect - 0; maximum - 16, means severe damage of both sphincters on a considerable length and circumference)
- Norderval scale for classification of anal sphincter injuries in transanal ultrasound (0-7 scale, no defect - 0, 7 is the maximal damage of both anal sphincters)
- anorectal manometry assessment to measure anal sphincters function
All measurements are used to estimate the presence, extent and severity of anal sphincter injury.
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 pelvic floor muscles using impedance spectroscopy.
Measured: 8 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: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start4 Feb 2019
- Primary completion30 Oct 2019
- Study completion23 Dec 2019
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- OASIS Diagnostics S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grzegorz Surkont, MD, PhD, Principal investigator, Centrum Medyczne Byc Kobieta s.c.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769792
- Sponsor's protocol ID
- 1/1/2018 (Sep 8)
- Status last verified
- Mar 2020
- First submitted
- 9 Oct 2018
- Last updated
- 4 Mar 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 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of Impedance Spectroscopy Device in Detecting Sphincter Injuries in Women After Natural Delivery
- ClinicalTrials.gov ID
- NCT03769792
- Acronym / sponsor ID
- 1/1/2018 (Sep 8)
- Keywords
- Obstetrical anal sphincter injury, Impedance spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- OASIS Diagnostics S.A.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 10 Dec 2018 (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 detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises 24 patients; included in it 6-8 weeks after natural delivery. The planned participation of each patient in the study is up to 4 weeks and three visits will take place at that time.
After obtaining written consent, at the screening visit (V0) each patient will undergo a physical examination, blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected.
On the second visit (V1), after the final verification of inclusion/exclusion criteria, impedance spectroscopy using tested device will be performed in each patient, the electrical impedance of pelvic floor muscles will be measured and the degree of anal sphincter damage will be evaluated. Full gynecological and proctological examination (including a gynecological speculum, two-handed examination, rectal examination and anoscopy) will be carried out.
On the third visit (V2), two reference diagnostic tests (with evidenced effectiveness and safety), transanal ultrasonography and anorectal manometry, will be conducted. The collected data will be used to select the optimal therapeutic method for each participant individually.
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 manometry24 women will be included in the study and divided into two subgroups. 12 of them (first subgroup) came from patients within 6 to 8 weeks after natural delivery, that had a perianal tear of grade 1 or 2 in OASIS classification. Remaining 12 (second subgroup) came from patients within 6 to 8 weeks after natural delivery, that had a perianal tear of grade 3 or 4 in OASIS classification. 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 (4 listed)
- after natural delivery and post-partum period (6-8 weeks after delivery)
- physiological pregnancy
- observed a perianal tear of grade 1-4 in the OASIS classification
- signed informed consent
Key exclusion criteria (11 listed)
- presence of acute diseases during treatment
- presence of chronic diseases untreated or insufficiently treated (e.g. poorly controlled hypertension),
- presence of diseases, with symptoms of fecal incontinence,
- previous proctological operations,
- the presence of inflammatory bowel diseases in the stage of exacerbation,
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 V0 - Laboratory tests, particularly for calprotectin concentration assessment | Diagnostic test | Impedance spectroscopy |
| Impedance spectroscopy testDuring V1 - the electrical impedance of pelvic floor muscles will be measured | Device | Impedance spectroscopy |
| Full gynecological and proctological examinationDuring V1 - Examination with a gynecological speculum, Two-handed examination, Rectal examination and Anoscopy | Diagnostic test | Impedance spectroscopy |
| Transanal ultrasonographyDuring V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results. | Diagnostic test | Impedance spectroscopy |
| Anorectal manometryDuring V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results. | Diagnostic test | Impedance spectroscopy |
Primary outcome
Anal sphincters injury
Time frame: 8 weeks
Assessed by subsequent measures: 1. Sphincter continuity in physical examination, 2. Sphincter tension in physical examination, 3. OASIS classification of perineal tears in transanal ultrasonography 4. Starck scale for classification of anal sphincter injuries in transanal ultrasound (0-16 scale, no defect - 0; maximum - 16, means severe damage of both sphincters on a considerable length and circumference) 5. Norderval scale for classification of anal sphincter injuries in transanal ultrasound (0-7 scale, no defect - 0, 7 is the maximal damage of both anal sphincters) 6. anorectal manometry assessment to measure anal sphincters function All measurements are used to estimate the presence, extent and severity of anal sphincter injury. 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 pelvic floor muscles using impedance spectroscopy.
1 secondary outcome
Adverse events
Time frame: 8 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 4 Mar 2020.
- Sponsor's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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
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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. This study is not recruiting at the moment.
Grzegorz Surkont, MD, PhD principal investigator
Centrum Medyczne Byc Kobieta s.c.
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, Obstetric, 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 4 inclusion and 11 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 4 Mar 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 injury (time frame: 8 weeks). 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 4 Mar 2020.