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Risks and Benefits of Urinary Catheter in Elective Cesarean Section

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03459963
Acronym
catheter
Enrollment
170
Registered
2018-03-09
Start date
2017-05-18
Completion date
2018-04-01
Last updated
2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Catheterization

Keywords

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

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

Interventions

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

Sponsors

World Health Organization
CollaboratorOTHER
Ain Shams Maternity Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Presence of UTI24-h postoperativemidstream 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

Secondary

MeasureTime frameDescription
Bladder injury incidence.intraoperativeaccidental bladder injury during operation
Intraoperative need of urethral catheter in N groupintraoperativeintraoperative need of catheter for any reason
Ambulation timeintraoperativefrom intraoperative skin opening time till the patient is able to move.
Operative durationintraoperativeThe time taken for surgery from skin opening to complete skin closure,
Urinary retentionfirst postoperative daydefined as no spontaneous micturition \>24 hours after cesarean delivery
Patient satisfactionsecond postoperative day morningusing four point likert scale from 1-4 (as 1 = not satisfied, 2 = partial satisfied, 3 = satisfied, 4 = very satisfied).
Postpartum hemorrhagefirst postoperative dayidentified when there is costant trickling f blood or repeated soakage of valval pad within 5 minutes

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026