Urinary CatheterNCT02074852
Comparison of Immediate Versus Delayed Removal of Urinary Catheter Following Elective Cesarean Section
An observational study of Urinary Catheter and Cesarean Section, run by Akmal El-Mazny at 1 site in Egypt.
Trial summary
The objective this trial is to compare immediate and 12 hours postoperative removal of urinary catheter after elective cesarean section; and whether early removal is associated with lower risk of urinary infection compared with delayed catheter removal. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Urinary Catheter, Cesarean Section, Urinary Infection
- What is being tested?
- Foley urethral catheter
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2012to Dec 2013
- Phase
- Observational
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women admitted to the prenatal wards for primary or repeat elective cesarean section
Who may be able to join
- Women admitted to the prenatal wards for primary or repeat elective cesarean section
Who cannot join
- urinary infection (assessed clinically and by midstream urinalysis),
- significant vaginal bleeding,
- severe pre-eclampsia or eclampsia and/or any other conditions requiring postoperative monitoring of urinary output, and
- contraindications for general anesthesia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University
Cairo
About this study
The objective this trial is to compare immediate and 12 hours postoperative removal of urinary catheter after elective cesarean section; and whether early removal is associated with lower risk of urinary infection compared with delayed catheter removal.
- Conditions
- Urinary Catheter, Cesarean Section, Urinary Infection
- Being tested
- Foley urethral catheter
- 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.
Foley urethral catheterOther
| Study group | Role | What they receive |
|---|---|---|
| Immediate catheter removal | The catheter was removed immediately after the CS Receives: Other: Foley urethral catheter | |
| Delayed catheter removal | The catheter was removed 12 hours postoperatively Receives: Other: Foley urethral catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases with significant bacteriuria and urinary symptoms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startNov 2012
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CatheterStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akmal El-Mazny
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Akmal El-Mazny, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074852
- Sponsor's protocol ID
- urinary catheter following CS
- Status last verified
- Mar 2014
- First submitted
- 24 Feb 2014
- Last updated
- 4 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immediate Versus Delayed Removal of Urinary Catheter Following Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT02074852
- Acronym / sponsor ID
- urinary catheter following CS
- Conditions
- Urinary Catheter, Cesarean Section, Urinary Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Akmal El-MaznyUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- First posted
- 28 Feb 2014 (estimated)
- 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.
The objective this trial is to compare immediate and 12 hours postoperative removal of urinary catheter after elective cesarean section; and whether early removal is associated with lower risk of urinary infection compared with delayed catheter removal.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate catheter removal | – | Other: Foley urethral catheterThe catheter was removed immediately after the CS |
| Delayed catheter removal | – | Other: Foley urethral catheterThe catheter was removed 12 hours postoperatively |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women admitted to the prenatal wards for primary or repeat elective cesarean section
Key inclusion criteria (1 listed)
- Women admitted to the prenatal wards for primary or repeat elective cesarean section
Key exclusion criteria (4 listed)
- urinary infection (assessed clinically and by midstream urinalysis),
- significant vaginal bleeding,
- severe pre-eclampsia or eclampsia and/or any other conditions requiring postoperative monitoring of urinary output, and
- contraindications for general anesthesia.
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 |
|---|---|---|
| Foley urethral catheter | Other | Delayed catheter removal, Immediate catheter removal |
Primary outcome
Number of cases with significant bacteriuria and urinary symptoms
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Catheter and Cesarean Section, run by Akmal El-Mazny 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 4 Mar 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of cases with significant bacteriuria and urinary symptoms (time frame: 1 year). 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 4 Mar 2014.