Oral Versus Intravenous Antibiotic Prophylaxis Before Obs... | NCT06255652

Studies
Oral Versus Intravenous Antibiotic Prophylaxis Before Obstetric and Gynecological Procedures

NCT06255652

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Feb 13, 2024Actual

Enrollment

1Estimated

Phase

Not provided

Conditions

Site Infection

Interventions

Cephradin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Actual

Primary Completion Date

Jul 31, 2024Estimated

Completion Date

Jul 31, 2024Estimated

First Submitted Date

Feb 5, 2024

First Submission Date that Met QC Criteria

Feb 5, 2024

First Posted Date

Feb 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2024

Last Update Posted Date

Feb 13, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yasmin Tharwat Anwar, Resident of obstetric and gynecology department, Sohag University Hospitals, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Name	Class
Randers Regional Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obstetrician and gynaecological procedures		Patients for obstetricians	Drug: Cephradin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cephradin	Drug	Velosef	Obstetrician and gynaecological procedures	Velosef

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
proportion of patients with any SSI within 30 days after surgery	July 2024	July 2024

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Cesarean section Gynaecological procedure Exclusion Criteria Immunocompromised patient

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Female patient Pregnant For gynaecological procedure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
yasmeen YT Tharwat, Resident	Contact	01289986222		yassmintharwat@med.sohag.edu.eg
Abdou a SAeed, Professor	Contact	01008385445

Overall Officials

Name	Affiliation	Role
Hatem Awaga Awaga, Doctor	Sohag University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag university hospital	Recruiting	Sohag		13331	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40334373	Derived	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.

Type	Date	Date Unknown
Release	Aug 12, 2024
Reset	Oct 23, 2024

ID	Term
D002506	Cephalexin
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577