Infection of Cesarian Section Wound Following DeliveryPhase 3TOAPFECSACTNCT02177994
Antibiotic Prophylaxis for Elective Cesarean Section
A Phase 3 study testing ceftriaxone 1gm for intravenous infusion in people with Infection of Cesarian Section Wound Following Delivery, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
A randomized controlled study comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infection of Cesarian Section Wound Following Delivery
- What is being tested?
- ceftriaxone 1gm for intravenous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2013to Nov 2014
- Phase
- Phase 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing elective cesarean section with Gestational age 37 weeks or more
Who cannot join
- Fever greater than 38°C or maternal sepsis.
- Cephalosporin allergy.
- Exposure to any antibiotic agent within 1week before delivery.
- Patents having premature rupture of membranes and acute chorioamnionitis.
- Patients with chronic diseases (diabetes mellitus, renal disease and Cardiac disease).
- 3) Morbid obesity (BMI>30)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timing of Antibiotic Prophylaxis for Elective Cesarean Section: A Randomized Controlled Trial
A randomized controlled study comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.
Read the detailed description
comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)
- Being tested
- ceftriaxone 1gm for intravenous infusion
- Keywords
- Elective Cesarean Section, Antibiotic prophylaxis, Timing of Antibiotic prophylaxis, post cesarean section infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftriaxone 1gm for intravenous infusionDrug
Also called cefaxon
Patients undergoing elective cesarean section with Gestational age 37 weeks or more. comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)
| Study group | Role | What they receive |
|---|---|---|
| Group A ceftriaxone after cord clamping | Experimental | 165 patients pregnant at 37weeks or more undergoing elective cesarean section randomly distributed to receive
1 gm. ceftriaxone via l intravenous infusion single dose after cord clamping. Receives: Drug: ceftriaxone 1gm for intravenous infusion |
| Group B ceftriaxone before skin incision | Active comparator | 165 patients pregnant at 37weeks or more undergoing elective cesarean section randomly distributed to receive
1 gm. ceftriaxone vial intravenous infusion single dose 30-60 minutes before skin incision. Receives: Drug: ceftriaxone 1gm for intravenous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the rate of post cesarean section surgical site infection.
postoperative assessment of SSI. Patients will be followed up at 48-72 hours postoperative, at 7th days (skin suture removal) and at 6 weeks (contraception application).all patients will be contacted by telephone and interviewed. They will be rescheduled for a clinic visit if they reported signs and symptoms of wound infection (purulent discharge or erythema >1 cm in diameter, induration of the incision site and fever).
Measured: administration of 1gm ceftriaxone prophylaxis for elective cs and follow up surgical site infection till 40 days
Secondary outcomes (1)
other post cesarean section maternal and neonatal infection
- Maternal complications: other post cesarean section maternal complications, namely endometritis, pyrexia, urinary tract infection and complication of drug administration such as anaphylaxis.
- Neonatal complications: such as neonatal sepsis
Measured: follow up ofother post cesarean section maternal and neonatal infection till 40 days of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection of Cesarian Section Wound Following DeliveryStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMR HELMY YEHIA, Ain Shams Maternity Hospital
- Investigators
- Amr AH Helmy, MD, Principal investigator, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177994
- Sponsor's protocol ID
- TOAPFECSACT
- Other IDs
- AinShamsMH
- Acronym
- TOAPFECSACT
- Status last verified
- Jun 2015
- First submitted
- 27 Jun 2014
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Antibiotic Prophylaxis for Elective Cesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02177994
- Acronym / sponsor ID
- TOAPFECSACT / TOAPFECSACT
- Keywords
- Elective Cesarean Section, Antibiotic prophylaxis, Timing of Antibiotic prophylaxis, post cesarean section infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Jun 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.
A randomized controlled study comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.
Detailed description
comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A ceftriaxone after cord clamping | Experimental | Drug: ceftriaxone 1gm for intravenous infusion165 patients pregnant at 37weeks or more undergoing elective cesarean section randomly distributed to receive 1 gm. ceftriaxone via l intravenous infusion single dose after cord clamping. |
| Group B ceftriaxone before skin incision | Active comparator | Drug: ceftriaxone 1gm for intravenous infusion165 patients pregnant at 37weeks or more undergoing elective cesarean section randomly distributed to receive 1 gm. ceftriaxone vial intravenous infusion single dose 30-60 minutes before skin incision. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing elective cesarean section with Gestational age 37 weeks or more
Key exclusion criteria (6 listed)
- Fever greater than 38°C or maternal sepsis.
- Cephalosporin allergy.
- Exposure to any antibiotic agent within 1week before delivery.
- Patents having premature rupture of membranes and acute chorioamnionitis.
- Patients with chronic diseases (diabetes mellitus, renal disease and Cardiac disease).
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 |
|---|---|---|
| ceftriaxone 1gm for intravenous infusionAlso: cefaxonPatients undergoing elective cesarean section with Gestational age 37 weeks or more. comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome) | Drug | Group A ceftriaxone after cord clamping, Group B ceftriaxone before skin incision |
Primary outcome
The primary outcome is the rate of post cesarean section surgical site infection.
Time frame: administration of 1gm ceftriaxone prophylaxis for elective cs and follow up surgical site infection till 40 days
postoperative assessment of SSI. Patients will be followed up at 48-72 hours postoperative, at 7th days (skin suture removal) and at 6 weeks (contraception application).all patients will be contacted by telephone and interviewed. They will be rescheduled for a clinic visit if they reported signs and symptoms of wound infection (purulent discharge or erythema >1 cm in diameter, induration of the incision site and fever).
1 secondary outcome
other post cesarean section maternal and neonatal infection
Time frame: follow up ofother post cesarean section maternal and neonatal infection till 40 days of delivery
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 25 Jun 2015.
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.
Amr AH Helmy, MD 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 Phase 3 study testing ceftriaxone 1gm for intravenous infusion in people with Infection of Cesarian Section Wound Following Delivery, 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 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: finished, as of the sponsor's last update on 25 Jun 2015. 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 phase mean?
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?
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?
The primary outcome is the rate of post cesarean section surgical site infection. (time frame: administration of 1gm ceftriaxone prophylaxis for elective cs and follow up surgical site infection till 40 days). 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 25 Jun 2015; AzTrials last refreshed its copy on 28 Oct 2026.