Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries
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ClinicalTrials.gov Identifier: NCT03769792 |
Recruitment Status :
Completed
First Posted : December 10, 2018
Last Update Posted : March 4, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | October 9, 2018 | ||||
First Posted Date ICMJE | December 10, 2018 | ||||
Last Update Posted Date | March 4, 2020 | ||||
Actual Study Start Date ICMJE | February 4, 2019 | ||||
Actual Primary Completion Date | October 30, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Anal sphincters injury [ Time Frame: 8 weeks ] Assessed by subsequent measures:
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Adverse events [ Time Frame: 8 weeks ] Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries | ||||
Official Title ICMJE | Evaluation of the Effectiveness and Safety of Impedance Spectroscopy Device in Detecting Sphincter Injuries in Women After Natural Delivery | ||||
Brief 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. 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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Impedance spectroscopy
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:
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE |
24 | ||||
Actual Study Completion Date ICMJE | December 23, 2019 | ||||
Actual Primary Completion Date | October 30, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 49 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Poland | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03769792 | ||||
Other Study ID Numbers ICMJE | 1/1/2018 (Sep 8) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | OASIS Diagnostics S.A. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | OASIS Diagnostics S.A. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | OASIS Diagnostics S.A. | ||||
Verification Date | March 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |