Risks and Benefits of Urinary Catheter in Elective Cesarean Section

NCT03459963 | Unknown

• 1 other identifier: elgammal
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Catheterization

Keywords

catheter; cesarean section; urinary tract infection; patient's satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Operative duration

  intraoperative

• Bladder injury incidence.

  intraoperative

• Intraoperative need of urethral catheter in N group

  intraoperative

• Ambulation time

  intraoperative

• Postpartum hemorrhage

  first postoperative day

Study Arms (2)

group C

EXPERIMENTAL

indwelling urinary catheter

Device: indwelling urinary catheter

group N

NO INTERVENTION

Non cathetrized patients

Interventions

indwelling urinary catheter DEVICE

85 women undergoing first elective CS will be catheterized immediately preoperatively using Foley's catheter by applying catheterization precautions.

group C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women undergoing first elective CS at term pregnancy (37-41w gestation).
• haemodynamically stable

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead
• World Health Organization: collaborator

Study Sites (1)

Ain Shams University Maternity Hospital.

Cairo, Egypt

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Tamer F borg

  Ain Shams Maternity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 9, 2018
• Study Start: May 18, 2017
• Primary Completion: December 20, 2017
• Study Completion: April 1, 2018
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

EG (1)