NCT06255652

Brief Summary

Oral versus intravenous antimicrobial prophylaxis for the prevention of surgical site infection for elective cesarean section and gynacological procedures

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

February 5, 2024

Last Update Submit

February 5, 2024

Conditions

Site Infection

Keywords

SSI

Outcome Measures

Primary Outcomes (1)

  • proportion of patients with any SSI within 30 days after surgery

    July 2024

    July 2024

Study Arms (1)

Obstetrician and gynaecological procedures

Patients for obstetricians

Drug: Cephradin

Interventions

CephradinDRUG

Velosef

Also known as: Velosef
Obstetrician and gynaecological procedures

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female patient Pregnant For gynaecological procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, 13331, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40334373DERIVED

MeSH Terms

Interventions

Cephradine

Intervention Hierarchy (Ancestors)

CephalexinCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Hatem Awaga Awaga, Doctor

    Sohag University

    STUDY DIRECTOR

Central Study Contacts

yasmeen YT Tharwat, Resident

CONTACT

01289986222yassmintharwat@med.sohag.edu.eg

Abdou a SAeed, Professor

CONTACT

01008385445

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of obstetric and gynecology department, Sohag University Hospitals

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 13, 2024

Study Start

October 1, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations

EG(1)