Risks and Benefits of Urinary Catheterization in Elective Cesarean Section: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Catheterization
- Sponsor
- Ain Shams Maternity Hospital
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Presence of UTI
- Last Updated
- 8 years ago
Overview
Brief Summary
This study aims to compare the routine use versus non-use of urethral catheterization in women undergoing first elective cesarean section as regard to intraoperative and postoperative complications
Detailed Description
This randomized controlled trial will be done at Ain Shams University Maternity One hundred and seventy pregnant women scheduled for first elective CS attending at outpatient clinic will be chosen after complete history and physical examination to determine eligibility for inclusion after taking their consent with full explanation of the study including potential benefits and risks. The study population will be randomized using computer sequence program in 1:1 ratio. Allocation of every patient to one of the studied groups will be done using opaque envelops. The studied groups will be either Group C or Group N For both groups * A written consent will be taken. * Full history to exclude medical problems that need special care. * Full history to exclude UTI or recurrent UTI during pregnancy. * A single dose of 2 gm cefazolin will be given IV pre-incision for preoperative antibiotic prophylaxis (Sullivan et al., 2007). * midstream urine samples will be collected preoperative to exclude UTI and 24 hours postoperatively after giving the instructions to the patients (washing hands and genitals ,pass some urine into the toilet then without stopping catch some urine in a sterile container ) to be analyzed for presence of UTI
Investigators
Dina Islam
Doctor
Ain Shams Maternity Hospital
Eligibility Criteria
Inclusion Criteria
- •Pregnant women undergoing first elective CS at term pregnancy (37-41w gestation).
- •haemodynamically stable
Exclusion Criteria
- •History of recurrent UTI during pregnancy, current UTI
- •presence of Medical complications that requiring special care e.g: diabetes with pregnancy, hypertensive disorders with pregnancy, cardiac disease, chronic renal disease,
- •previous cesarean section
- •Previous abdominal surgery which may be associated with extensive adhesions, -polyhydraminos
- •fetal macrosomia
- •significant vaginal bleeding
- •Contraindication for the antibiotic used e.g: anaphylaxis
- •Need for extensive use of antibiotics more than the prophylactic dose
- •Spinal anesthesia.
Outcomes
Primary Outcomes
Presence of UTI
Time Frame: 24-h postoperative
midstream urine samples were collected 24 hours postoperatively after giving the instructions to the patients and tested for presence of UTI. These fresh non-centrifuged urine samples were collected and tested for leukocyte esterase and nitrite using (Convergys urine matrix 10, Germany) strips. Nitrite will be considered positive if there is change in color of dipstick from colorless towards pink within 60 seconds. Leukocyte esterase will be considered positive if there is change in color from off-white towards purple within 2 minutes
Secondary Outcomes
- Intraoperative need of urethral catheter in N group(intraoperative)
- Bladder injury incidence.(intraoperative)
- Patient satisfaction(second postoperative day morning)
- Urinary retention(first postoperative day)
- Operative duration(intraoperative)
- Ambulation time(intraoperative)
- Postpartum hemorrhage(first postoperative day)