Status:
COMPLETED
Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries
Lead Sponsor:
OASIS Diagnostics S.A.
Conditions:
Obstetric Anal Sphincter Injury
Delivery, Obstetric
Eligibility:
FEMALE
18-49 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- after natural delivery and post-partum period (6-8 weeks after delivery)
- physiological pregnancy
- observed a perianal tear of grade 1-4 in the OASIS classification
- signed informed consent
Exclusion
- presence of acute diseases during treatment
- presence of chronic diseases untreated or insufficiently treated (e.g. poorly controlled hypertension),
- presence of diseases, with symptoms of fecal incontinence,
- previous proctological operations,
- the presence of inflammatory bowel diseases in the stage of exacerbation,
- treatment in the last year due to severe, progressive, uncontrolled cardiac, pulmonary, nephrological, infectious or psychiatric disease, which course could affect the patient's risk due to participation in study,
- significant deviations from the norm in a physical examination during V0 visit or laboratory tests taken during the same visit,
- significant disease symptoms so far undiagnosed and reported during the V0 visit
- presence or suspected malignant disease or previous oncological treatment during the last 5 years,
- presence of a cardiac stimulator or cardioverter-defibrillator,
- severe surgery or severe trauma in the last year.
Key Trial Info
Start Date :
February 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03769792
Start Date
February 4 2019
End Date
December 23 2019
Last Update
March 4 2020
Active Locations (1)
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1
Centrum Medyczne Byc Kobieta s.c.
Lodz, Łódź Voivodeship, Poland, 95-070