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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT03513250
Eligibility Criteria:
Inclusion Criteria:
* Elective primary or repeat cesarean section at or more than 38 weeks of gestation scheduled to insert a Foley catheter in the operation site.
Exclusion Criteria:
* • Urinary infection (assessed clinically and by urinalysis of midstream sample of urine (MSSU) with chemical indicator strips or dipsticks).
* Contraindications for general anesthesia.
* Maternal bladder, urethral and renal disorders causing irritating voiding problems such as dysuria, urge and stress incontinence.
* Obstructive voiding symptoms like incomplete emptying, straining and voiding difficulty before surgery.
* Overactive bladder (frequency: more than three times during the night or more than eight times in 24 h).
* Morbid obesity.
* Disturbances of the central nervous system (epilepsy, patients receiving MAO inhibitor).
* Hypertensive disorders and/ or systemic disease requiring particular patient care (for example, cardiac disease, nephritic disorders).
* Chronic analgesic abuse.
* Hepatic or psychiatric disease will be excluded from the study.
* A history of hypersensitivity or contraindication to hyoscine-n-butylbromide.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03513250
Study Brief:
Protocol Section:
NCT03513250