Risks and Benefits of Urinary Catheter in Elective Cesarean Section

Urinary Catheterization Clinical Trial

— catheter  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03459963
• Other study ID #: elgammal
• Status: Active, not recruiting
• Phase: N/A
• First received: February 28, 2018
• Last updated: March 8, 2018
• Start date: May 18, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: March 2018
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: April 1, 2018
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Urinary Catheterization

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital.	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital	World Health Organization

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative duration	The time taken for surgery from skin opening to complete skin closure,	intraoperative
Secondary	Bladder injury incidence.	accidental bladder injury during operation	intraoperative
Secondary	Intraoperative need of urethral catheter in N group	intraoperative need of catheter for any reason	intraoperative
Secondary	Ambulation time	from intraoperative skin opening time till the patient is able to move.	intraoperative
Secondary	Postpartum hemorrhage	identified when there is costant trickling f blood or repeated soakage of valval pad within 5 minutes	first postoperative day
Secondary	Urinary retention	defined as no spontaneous micturition >24 hours after cesarean delivery	first postoperative day
Secondary	Patient satisfaction	using four point likert scale from 1-4 (as 1 = not satisfied, 2 = partial satisfied, 3 = satisfied, 4 = very satisfied).	second postoperative day morning