Site InfectionNCT06255652
Oral Versus Intravenous Antibiotic Prophylaxis Before Obstetric and Gynecological Procedures
An observational study of Site Infection, run by Sohag University at 1 site in Egypt.
Trial summary
Oral versus intravenous antimicrobial prophylaxis for the prevention of surgical site infection for elective cesarean section and gynacological procedures Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Site Infection
- What is being tested?
- Cephradin
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 31 Jul 2024
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patient Pregnant For gynaecological procedure
Who may be able to join
- Cesarean section Gynaecological procedure Exclusion Criteria Immunocompromised patient
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Abdou a SAeed, Professor contact
About this study
Oral versus intravenous antimicrobial prophylaxis for the prevention of surgical site infection for elective cesarean section and gynacological procedures
Read the detailed description
the aim of the current study is to compare the efficacy of prophylactic intravenous (cephradine) and oral antibiotic (cephradine) for the prevention of surgical site infection in the elective obctetric and gynecological procedures
- Conditions
- Site Infection
- Being tested
- Cephradin
- Keywords
- SSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CephradinDrug
Also called Velosef
Velosef
| Study group | Role | What they receive |
|---|---|---|
| Obstetrician and gynaecological procedures | Patients for obstetricians Receives: Drug: Cephradin |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with any SSI within 30 days after surgery
July 2024
Measured: July 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Oct 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
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 Site InfectionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital
- Responsible party
- Principal investigator, Yasmin Tharwat Anwar, Sohag University
- Investigators
- Hatem Awaga Awaga, Doctor, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255652
- Sponsor's protocol ID
- Soh-Med-23-09-05MS
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Elftooh Awaga HA, Anwar YT, Ait-Allah AS, Abdelkareem AO. Oral versus intravenous antibiotic prophylaxis before obstetric and gynecological surgical interventions: A randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2025 Jul;311:114020. doi: 10.1016/j.ejogrb.2025.114020. Epub 2025 Apr 29.
PubMed 40334373
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Intravenous Antibiotic Prophylaxis Before Obstetric and Gynecological Procedures
- ClinicalTrials.gov ID
- NCT06255652
- Acronym / sponsor ID
- Soh-Med-23-09-05MS
- Conditions
- Site Infection
- Keywords
- SSI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Collaborators
- Randers Regional Hospital
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 13 Feb 2024 (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.
Oral versus intravenous antimicrobial prophylaxis for the prevention of surgical site infection for elective cesarean section and gynacological procedures
Detailed description
the aim of the current study is to compare the efficacy of prophylactic intravenous (cephradine) and oral antibiotic (cephradine) for the prevention of surgical site infection in the elective obctetric and gynecological procedures
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstetrician and gynaecological procedures | – | Drug: CephradinPatients for obstetricians |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patient Pregnant For gynaecological procedure
Key inclusion criteria (2 listed)
- Cesarean section Gynaecological procedure Exclusion Criteria Immunocompromised patient
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CephradinAlso: VelosefVelosef | Drug | Obstetrician and gynaecological procedures |
Primary outcome
proportion of patients with any SSI within 30 days after surgery
Time frame: July 2024
July 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 40334373Elftooh Awaga HA, Anwar YT, Ait-Allah AS, Abdelkareem AO. Oral versus intravenous antibiotic prophylaxis before obstetric and gynecological surgical interventions: A randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2025 Jul;311:114020. doi: 10.1016/j.ejogrb.2025.114020. Epub 2025 Apr 29.
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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.
Abdou a SAeed, Professor contact
Hatem Awaga Awaga, Doctor study director
Sohag University
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 Site Infection, run by Sohag 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 2 inclusion and 0 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 13 Feb 2024. 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?
Contact yasmeen YT Tharwat, Resident (01289986222, yassmintharwat@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with any SSI within 30 days after surgery (time frame: July 2024). 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 NCT06255652, 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 13 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.