Urinary CatheterizationcatheterNCT03459963
Risks and Benefits of Urinary Catheter in Elective Cesarean Section
A study testing indwelling urinary catheter in people with Urinary Catheterization, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Urinary Catheterization
- What is being tested?
- indwelling urinary catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 18 May 2017to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women undergoing first elective CS at term pregnancy (37-41w gestation).
- haemodynamically stable
Who cannot join
- 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
Show all 9Show fewer
- Contraindication for the antibiotic used e.g: anaphylaxis
- Need for extensive use of antibiotics more than the prophylactic dose
- Spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risks and Benefits of Urinary Catheterization in Elective Cesarean Section: A Randomized Controlled Trial
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
Read the 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
- Being tested
- indwelling urinary catheter
- Keywords
- catheter, cesarean section, urinary tract infection, patient's satisfaction
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indwelling urinary catheterDevice
85 women undergoing first elective CS will be catheterized immediately preoperatively using Foley's catheter by applying catheterization precautions.
| Study group | Role | What they receive |
|---|---|---|
| group C | Experimental | indwelling urinary catheter Receives: Device: indwelling urinary catheter |
| group N | No intervention | Non cathetrized patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24-h postoperative
Secondary outcomes (7)
Operative duration
The time taken for surgery from skin opening to complete skin closure,
Measured: intraoperative
Bladder injury incidence.
accidental bladder injury during operation
Measured: intraoperative
Intraoperative need of urethral catheter in N group
intraoperative need of catheter for any reason
Measured: intraoperative
Ambulation time
from intraoperative skin opening time till the patient is able to move.
Measured: intraoperative
Postpartum hemorrhage
identified when there is costant trickling f blood or repeated soakage of valval pad within 5 minutes
Measured: first postoperative day
Urinary retention
defined as no spontaneous micturition >24 hours after cesarean delivery
Measured: first postoperative day
Patient satisfaction
using four point likert scale from 1-4 (as 1 = not satisfied, 2 = partial satisfied, 3 = satisfied, 4 = very satisfied).
Measured: second postoperative day morning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start18 May 2017
- Primary completion20 Dec 2017
- Study completion1 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Dina Islam, Ain Shams Maternity Hospital
- Investigators
- Tamer F borg, Principal investigator, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459963
- Sponsor's protocol ID
- elgammal
- Acronym
- catheter
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risks and Benefits of Urinary Catheterization in Elective Cesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03459963
- Acronym / sponsor ID
- catheter / elgammal
- Conditions
- Urinary Catheterization
- Keywords
- catheter, cesarean section, urinary tract infection, patient's satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- 18 May 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group C | Experimental | Device: indwelling urinary catheterindwelling urinary catheter |
| group N | No intervention | –Non cathetrized patients |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women undergoing first elective CS at term pregnancy (37-41w gestation).
- haemodynamically stable
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indwelling urinary catheter85 women undergoing first elective CS will be catheterized immediately preoperatively using Foley's catheter by applying catheterization precautions. | Device | group C |
Primary outcome
Presence of UTI
Time frame: 24-h postoperative
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
7 secondary outcomes
Operative duration
Time frame: intraoperative
Bladder injury incidence.
Time frame: intraoperative
Intraoperative need of urethral catheter in N group
Time frame: intraoperative
Ambulation time
Time frame: intraoperative
Postpartum hemorrhage
Time frame: first postoperative day
Urinary retention
Time frame: first postoperative day
Patient satisfaction
Time frame: second postoperative day morning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamer F borg principal investigator
Ain Shams Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing indwelling urinary catheter in people with Urinary Catheterization, run by Ain Shams Maternity Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of UTI (time frame: 24-h postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.