CaesareanPhase 4NCT01347593
Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery
A Phase 4 study testing ceftizoxime in people with Caesarean, run by University of Khartoum at 1 site in Sudan.
Trial summary
Ceftizoxime (Cefizox) will reduce post Cesarean delivery febrile morbidity. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- Caesarean
- What is being tested?
- ceftizoxime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSudan
- Study dates
- May 2011to Aug 2011
- Phase
- Phase 4
- 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 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Elective Cesarean section
Who cannot join
- Diabetes severe anaemia allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery in Soba Hospital Sudan
Ceftizoxime (Cefizox) will reduce post Cesarean delivery febrile morbidity.
- Conditions
- Caesarean
- Being tested
- ceftizoxime
- Keywords
- ceftizoxime, Cesarean, post caesarean febrile morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftizoximeDrug
Also called cefizox
ceftizoxime (cefizox) injection either after clamping the cord
| Study group | Role | What they receive |
|---|---|---|
| ceftizoxime (cefizox) injection | Experimental | ceftizoxime (cefizox) as single dose of 1 g at the interval of 30-60 minutes before the incision Receives: Drug: ceftizoxime |
What is being measured
The primary outcome is the main question the study is designed to answer.
reducing post Cesarean section febrile morbidity
reducing infection rate
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaesareanStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Khartoum
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Sudan
- Responsible party
- Principal investigator, Ishag Adam, University of Khartoum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347593
- Sponsor's protocol ID
- ceftizoxime cesarean
- Status last verified
- Jan 2013
- First submitted
- 2 May 2011
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Osman B, Abbas A, Ahmed MA, Abubaker MS, Adam I. Prophylactic ceftizoxime for elective cesarean delivery at Soba Hospital, Sudan. BMC Res Notes. 2013 Feb 8;6:57. doi: 10.1186/1756-0500-6-57.
PubMed 23394621
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery in Soba Hospital Sudan
- ClinicalTrials.gov ID
- NCT01347593
- Acronym / sponsor ID
- ceftizoxime cesarean
- Conditions
- Caesarean
- Keywords
- ceftizoxime, Cesarean, post caesarean febrile morbidity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of KhartoumUniversity, hospital or other
- Collaborators
- Ministry of Health, Sudan
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 May 2011 (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.
Ceftizoxime (Cefizox) will reduce post Cesarean delivery febrile morbidity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ceftizoxime (cefizox) injection | Experimental | Drug: ceftizoximeceftizoxime (cefizox) as single dose of 1 g at the interval of 30-60 minutes before the incision |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Elective Cesarean section
Key exclusion criteria (1 listed)
- Diabetes severe anaemia allergy
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 |
|---|---|---|
| ceftizoximeAlso: cefizoxceftizoxime (cefizox) injection either after clamping the cord | Drug | ceftizoxime (cefizox) injection |
Primary outcome
reducing post Cesarean section febrile morbidity
Time frame: 4 days
reducing infection rate
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 17 Jan 2013.
- Derived from this study: PubMed 23394621Osman B, Abbas A, Ahmed MA, Abubaker MS, Adam I. Prophylactic ceftizoxime for elective cesarean delivery at Soba Hospital, Sudan. BMC Res Notes. 2013 Feb 8;6:57. doi: 10.1186/1756-0500-6-57.
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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?
A Phase 4 study testing ceftizoxime in people with Caesarean, run by University of Khartoum at 1 site in Sudan.
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 1 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 17 Jan 2013. 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 Sudan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
reducing post Cesarean section febrile morbidity (time frame: 4 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 NCT01347593, which also lists 1 linked publication.
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 17 Jan 2013.