Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT03769792
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT03769792
Study Brief:
Protocol Section:
NCT03769792