Risks and Benefits of Urinary Catheter in Elective Cesarean Section (catheter)

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

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

Study Overview

• Status: Unknown
• Conditions: Urinary Catheterization
• Intervention / Treatment: Device: indwelling urinary catheter

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

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Maternity Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Collaborators: World Health Organization
• Investigators: Principal Investigator: Tamer F borg, Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2017
• Primary Completion (Actual): December 20, 2017
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: cesarean section; urinary tract infection; catheter; patient's satisfaction
• Other Study ID Numbers: elgammal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No