Risks and Benefits of Urinary Catheter in Elective Cesarean Section

Study Overview
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Brief Summary
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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
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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

Official Title
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Risks and Benefits of Urinary Catheterization in Elective Cesarean Section: A Randomized Controlled Trial

Conditions
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Urinary Catheterization

Intervention / Treatment
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* Device: indwelling urinary catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group C<br>indwelling urinary catheter | Device: indwelling urinary catheter<br>* 85 women undergoing first elective CS will be catheterized immediately preoperatively using Foley's catheter by applying catheterization precautions.<br>|
| No Intervention: group N<br>Non cathetrized patients | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of UTI | 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 | 24-h postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative duration | The time taken for surgery from skin opening to complete skin closure, | intraoperative | 
| Bladder injury incidence. | accidental bladder injury during operation | intraoperative | 
| Intraoperative need of urethral catheter in N group | intraoperative need of catheter for any reason | intraoperative | 
| Ambulation time | from intraoperative skin opening time till the patient is able to move. | intraoperative | 
| Postpartum hemorrhage | identified when there is costant trickling f blood or repeated soakage of valval pad within 5 minutes | first postoperative day | 
| Urinary retention | defined as no spontaneous micturition >24 hours after cesarean delivery | first postoperative day | 
| Patient satisfaction | using four point likert scale from 1-4 (as 1 = not satisfied, 2 = partial satisfied, 3 = satisfied, 4 = very satisfied). | second postoperative day morning | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter, cesarean section, urinary tract infection, patient's satisfaction