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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and faeces tests | Diagnostic Test | During V0 - Laboratory tests, particularly for calprotectin concentration assessment |
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| Measure | Description | Time Frame |
|---|---|---|
| Anal sphincters injury | Assessed by subsequent measures:
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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Evaluation of the frequency and intensity of adverse events associated with the use of the new diagnostic method. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grzegorz Surkont, MD, PhD | Centrum Medyczne Byc Kobieta s.c. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centrum Medyczne Byc Kobieta s.c. | Lodz | Łódź Voivodeship | 95-070 | Poland |
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| Label | URL |
|---|---|
| Sponsor's website | View source |
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| Impedance spectroscopy test | Device | During V1 - the electrical impedance of pelvic floor muscles will be measured |
|
| Full gynecological and proctological examination | Diagnostic Test | During V1 - Examination with a gynecological speculum, Two-handed examination, Rectal examination and Anoscopy |
|
| Transanal ultrasonography | Diagnostic Test | During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results. |
|
| Anorectal manometry | Diagnostic Test | During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results. |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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