Risks and Benefits of Urinary Catheter in Elective Cesarean Section

NCT ID: NCT03459963

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-18
• Study Completion Date: 2018-04-01

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

Conditions

Urinary Catheterization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

group C

indwelling urinary catheter

Group Type: EXPERIMENTAL

indwelling urinary catheter

Intervention Type: DEVICE

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

group N

Non cathetrized patients

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

indwelling urinary catheter

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dina Islam

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamer F borg

Role: PRINCIPAL_INVESTIGATOR

Ain Shams Maternity Hospital

Locations

Ain Shams University Maternity Hospital.

Cairo, , Egypt

Countries

Egypt

Other Identifiers

elgammal

Identifier Type: -

Identifier Source: org_study_id