The main purpose of the study is to confirm the clinical performance and safety of impedance spectroscopy using the ONIRY device for the detection of anal sphincter injuries arising from vaginal deliveries.
The study group comprises 150 primiparous or multiparous women up to 8 weeks after the vaginal (spontaneous or assisted) delivery of singleton, live foetus, in any presentation, in gestational week 34 or more. The timeline for each subject in the study will be up to 5 weeks and will include 3 visits (V1-V3).
All participants will be divided into 3 groups: A, B, C. Group A - subjects with no perineal tear signs, Group B - subjects with grade 1 or 2 per OASIS classification, and Group C - subjects with grade 3 or 4).
The diagnostic performance will be evaluated in comparison to 3-D EUS (endoanal ultrasound) as a primary performance measure (primary endpoint).
Who can participate
Age range18 Years – 49 Years
SexFEMALE
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Inclusion criteria
✓. Women between 18 and 49 years old;
✓. Primiparous or multiparous;
✓. Since the first moments up to 8 weeks after vaginal delivery (including spontaneous and assisted):
✓. of singleton, live foetus,
✓. in any presentation,
✓. in gestational week 34 or more.
✓. For group A:
✓. no clinical signs of any degree perineal tear
Exclusion criteria
✕. Any acute, uncontrolled disease (except for haemorrhoidal disease)
✕. Chronic diseases not treated or not stable on treatment;
✕. Symptoms of faecal incontinence due to a disease other than diagnosed or suspected OASIS;
What they're measuring
1
Diagnostic Outcome in Clinically-evaluable (CE) Population with 3-D EUS used as the reference diagnostic method
. Previous surgery for OASIS (primary or secondary), faecal incontinence or anal prolapse, except for a primary repair of anal sphincter damage performed after the last delivery (allowed);
✕. Any surgery in perineal or rectal area, including surgery for OASIS, planned for the study period
✕. Presence of inflammatory bowel diseases during exacerbation phase;
✕. Any treatment during last 12 months for severe, progressive, uncontrolled cardiological, pulmonary, nephrology, contagious or psychiatric illness that could increase subject's risk due to participation in the study,
✕. Disease other than OASIS so far undiagnosed and reported during the visit V1 or within 7 days prior to it;