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

A

Ain Shams Maternity Hospital

Status

Unknown

Conditions

Urinary Catheterization

Treatments

Device: indwelling urinary catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT03459963
elgammal

Details and patient eligibility

About

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

Full 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

Enrollment

170 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

170 participants in 2 patient groups

group C
Experimental group
Description:
indwelling urinary catheter
Treatment:
Device: indwelling urinary catheter
group N
No Intervention group
Description:
Non cathetrized patients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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