Emergency Cesarean SectionPhase 2/3NCT04009772
Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic During Emergency Intrapartum Cesarean Section
A Phase 2/3 study testing Cefepime and Cefuroxime plus Metronidazole in people with Emergency Cesarean Section and Infection Wound, run by Assiut University at 1 site in Egypt.
Trial summary
Compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emergency Cesarean Section, Infection Wound
- What is being tested?
- Cefepime and Cefuroxime plus Metronidazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 1 Mar 2020
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- intrapartum caesarean section
Who cannot join
- evidence of infection
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Abdalmageed, 1007972027, drosamast@yahoo.com.au
About this study
Official title: Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic: A Randomized Controlled Study
Compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care
Read the detailed description
This is a randomized double blinded study which compare between single dose cefepime versus cefuroxime plus metronidazole during emergency intrapartum cesarean section.
Outcomes will include fever, wound infection, and urinary tract infection.
- Conditions
- Emergency Cesarean Section, Infection Wound
- Being tested
- Cefepime, Cefuroxime plus Metronidazole
- Keywords
- Cefepime, Cefuroxime, Metronidazole, Cesarean, Intrapartum
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefepimeDrug
Also called Maxipime
Antibiotic prophylaxis
Cefuroxime plus MetronidazoleDrug
Also called Zinnat plus Flagyl
Antibiotic prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| "Cefepime" , "Maxipime®" 1 gm | Active comparator | Patient will receive "Cefepime" ,"Maxipime®" 1 gm IV during cesarean section just before skin incision Receives: Drug: Cefepime |
| "Cefuroxime", "Zinnat®" 1gm plus "metronidazole"Flagyl®" 500 | Active comparator | Patient will receive "Cefuroxime", "Zinnat®" 1gm ,and "metronidazole"Flagyl®" 500 IV; just before skin incision for emergency cesarean section Receives: Drug: Cefuroxime plus Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site wound infection
Examining the wound after one week of the surgery to detect any infection
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Jul 2019
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Yasser Esmat Mohammed
- Responsible party
- Principal investigator, Osama Saber Thabet Abdalmageed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009772
- Sponsor's protocol ID
- Antibiotic CS
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04009772
- Acronym / sponsor ID
- Antibiotic CS
- Conditions
- Emergency Cesarean Section, Infection Wound
- Keywords
- Cefepime, Cefuroxime, Metronidazole, Cesarean, Intrapartum
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Yasser Esmat Mohammed
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 5 Jul 2019 (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.
Compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care
Detailed description
This is a randomized double blinded study which compare between single dose cefepime versus cefuroxime plus metronidazole during emergency intrapartum cesarean section.
Outcomes will include fever, wound infection, and urinary tract infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Cefepime" , "Maxipime®" 1 gm | Active comparator | Drug: CefepimePatient will receive "Cefepime" ,"Maxipime®" 1 gm IV during cesarean section just before skin incision |
| "Cefuroxime", "Zinnat®" 1gm plus "metronidazole"Flagyl®" 500 | Active comparator | Drug: Cefuroxime plus MetronidazolePatient will receive "Cefuroxime", "Zinnat®" 1gm ,and "metronidazole"Flagyl®" 500 IV; just before skin incision for emergency cesarean section |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- intrapartum caesarean section
Key exclusion criteria (1 listed)
- evidence of infection
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 |
|---|---|---|
| CefepimeAlso: MaxipimeAntibiotic prophylaxis | Drug | "Cefepime" , "Maxipime®" 1 gm |
| Cefuroxime plus MetronidazoleAlso: Zinnat plus FlagylAntibiotic prophylaxis | Drug | "Cefuroxime", "Zinnat®" 1gm plus "metronidazole"Flagyl®" 500 |
Primary outcome
Incidence of surgical site wound infection
Time frame: one week
Examining the wound after one week of the surgery to detect any infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cefepime and Cefuroxime plus Metronidazole in people with Emergency Cesarean Section and Infection Wound, run by Assiut 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 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: status not confirmed, as of the sponsor's last update on 5 Jul 2019. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Abdalmageed Abdalmageed (+201007972027, drosamast@yahoo.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical site wound infection (time frame: one week). 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 5 Jul 2019.