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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and faeces tests | Diagnostic Test | During V1 - Laboratory tests, particularly for calprotectin concentration assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anal sphincters continuity (injuries) assessed in physical examination and trancanal ultrasonography | Assessment using:
| 16 weeks |
| Anal sphincter tension (function) assessed in physical examination and anorectal manometry | 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. | 16 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. | 16 weeks |
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Inclusion Criteria:
women patients,
18-49 years old,
up to 16 weeks from a natural delivery
with the presence of:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Małgorzata Uchman-Musielak, MD, PhD | Specialist Medical Practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praktyka Lekarska Małgorzata Uchman-Musielak | Warsaw | Masovian Voivodeship | 05-077 | 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 anal sphincter muscles will be measured |
|
| Full gynecological and proctological examination | Diagnostic Test | During V1 and V2 - Examination with a gynecological speculum, Two-handed examination, Rectal examination, and Anoscopy |
|
| Transanal ultrasonography | Diagnostic Test | During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results. |
|
| Anorectal manometry | Diagnostic Test | During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results. |
|
| Determining the degree of sphincter injury | Other | 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. |
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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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