Wound InfectionCDSECDNCT02143089

Catheterization During Second Elective Caesarean Delivery

A study testing Foley's Catheter in people with Wound Infection, run by Ain Shams University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Use versus non use of urinary catheterization during Second Elective caesarean delivery: Read more about this study

Who is it for?: Ages 20 to 38 years, women onlyHealthy volunteers can take part
Conditions the study is for: Wound Infection
What is being tested?: Foley's Catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: 1 siteEgypt
Study dates: Aug 2013to Sep 2014
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 20 to 38 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

pregnant females who will undergo second elective caesarean section at full term pregnancy (38:41 weeks gestational age).

Who cannot join

Women with history of more than one previous caesarean Section.
Women with history of a tonic postpartum hemorrhage.
Women with Urinary tract infection in present pregnancy.
Women with diabetes mellitus in present pregnancy.
Women with medical disorder in present pregnancy that obligate monitoring of urine output during and after caesarean section, such as severe pre-eclampsia or renal disease with pregnancy.
Emergency caesarean section

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting

AinShamsU
Cairo, +20
Amr Helmy, Master, 01227900014
Amr Helmy, Master
Recruiting

Other trials in Egypt

About this study

Official title: Evaluation OF Use Versus Non Use of Urinary Catheterization During Second Elective Caesarean Delivery

Use versus non use of urinary catheterization during Second Elective caesarean delivery:

Read the detailed description

Evaluation OF use versus non use of urinary catheterization during Second Elective caesarean delivery:by urine analysis 24 hours postoperative to exclude urinary tract infection.

Conditions: Wound Infection
Being tested: Foley's Catheter
Keywords: CCSWI
Medical subject headings: Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Foley's CatheterDevice
Urinary tract infection inpatient catheterized versus non catheterized

Study groups in NCT02143089
Study group	Role	What they receive
Group 1	Active comparator	Use of urinary catheterization in Cesarean section Receives: Device: Foley's Catheter
Group 2	No intervention	NO urinary catheterization during Cesarean section

What is being measured

The primary outcome is the main question the study is designed to answer.

Urine analysis to diagnosed urinary tract infection by leucocytes more than 10 per high power field
Measured: participants will be followed for the duration of urinary tract infection,an expected average 2 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Sep 2014

First posted20 May 2014 (estimated)
Study startAug 2013
Primary completionAug 2014 (estimated)
Study completionSep 2014 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Wound InfectionStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 220 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02143089
Sponsor's protocol ID: HSM28-10-12
Acronym: CDSECD
Status last verified: May 2014
First submitted: 6 May 2014
Last updated: 20 May 2014
Results posted: No
Data monitoring committee: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Wound Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation OF Use Versus Non Use of Urinary Catheterization During Second Elective Caesarean Delivery
ClinicalTrials.gov ID: NCT02143089
Acronym / sponsor ID: CDSECD / HSM28-10-12
Conditions: Wound Infection
Keywords: CCSWI
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 220 participants (estimated)
Lead sponsor: Ain Shams UniversityUniversity, hospital or other
Study start: Aug 2013
Primary completion: Aug 2014 (estimated)
Study completion: Sep 2014 (estimated)
First posted: 20 May 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.

Use versus non use of urinary catheterization during Second Elective caesarean delivery:

Detailed description

Evaluation OF use versus non use of urinary catheterization during Second Elective caesarean delivery:by urine analysis 24 hours postoperative to exclude urinary tract infection.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Group 1	Active comparator	Device: Foley's CatheterUse of urinary catheterization in Cesarean section
Group 2	No intervention	–NO urinary catheterization during Cesarean section

Who may qualify

Ages: 20 to 38 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

pregnant females who will undergo second elective caesarean section at full term pregnancy (38:41 weeks gestational age).

Key exclusion criteria (6 listed)

Women with history of more than one previous caesarean Section.
Women with history of a tonic postpartum hemorrhage.
Women with Urinary tract infection in present pregnancy.
Women with diabetes mellitus in present pregnancy.
Women with medical disorder in present pregnancy that obligate monitoring of urine output during and after caesarean section, such as severe pre-eclampsia or renal disease with pregnancy.

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's CatheterUrinary tract infection inpatient catheterized versus non catheterized	Device	Group 1

Primary outcome

Urine analysis to diagnosed urinary tract infection by leucocytes more than 10 per high power field
Time frame: participants will be followed for the duration of urinary tract infection,an expected average 2 days.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.

Related trials for Wound Infection

Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Suture Choice for Ostomy Creation
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Enrolling by invitation
Fareon Open Label Device Clinical Trial
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Not yet recruitingPhase 3
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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.

AinShamsU

Cairo, Egypt

01227900014

Amr Helmy, Master principal investigator

Ain Shams University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Foley's Catheter in people with Wound Infection, run by Ain Shams University 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 6 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 20 May 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urine analysis to diagnosed urinary tract infection by leucocytes more than 10 per high power field (time frame: participants will be followed for the duration of urinary tract infection,an expected average 2 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02143089.

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 20 May 2014.