Obstetric Complication Clinical Trial
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.
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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