Clinical trial NCT03459963: Risks and Benefits of Urinary Catheter in Elective Cesarean Section
Official title: Risks and Benefits of Urinary Catheterization in Elective Cesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Catheterization
Keywords: catheter
cesarean section
urinary tract infection
patient's satisfaction
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2018-03-09
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Presence of UTI
timeFrame: 24-h postoperative
Secondary outcomes:
measure: Operative duration
timeFrame: intraoperative
measure: Bladder injury incidence.
timeFrame: intraoperative
measure: Intraoperative need of urethral catheter in N group
timeFrame: intraoperative
measure: Ambulation time
timeFrame: intraoperative
measure: Postpartum hemorrhage
timeFrame: first postoperative day
measure: Urinary retention
timeFrame: first postoperative day
measure: Patient satisfaction
timeFrame: second postoperative day morning
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital.
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Tamer F borg
role: PRINCIPAL_INVESTIGATOR
References: