NCT06048692

Brief Summary

the aim of this study is to evaluate the efficacy of employing cefepime (CFM) versus ampicillin/sulbactam (AMS) in lowering the rate of post-cesarean surgical site infections.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
213

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 16, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

September 16, 2023

Last Update Submit

September 16, 2023

Conditions

Cesarean Section; Infection

Keywords

surgical site infectionCefepime

Outcome Measures

Primary Outcomes (1)

  • surgical site infection

    pain, redness, swelling, warm skin around the wound, yellow or green discharge

    1 month

Study Arms (2)

Cefepime Group

EXPERIMENTAL

Pregnant women (n=100) received IV cefepime (CEF) (maxipime®1000mg) 30 minutes before cesarean delivery (CD) and 12 hours after CD

Drug: Cefepime 1000 MG

Ampicillin/Sulbactam

ACTIVE COMPARATOR

Pregnant women (n=100) received IV Ampicillin/Sulbactam (AMS) (Unictam® 1500 mg) 30 minutes before CD and 12 hours after CD

Drug: Ampicillin-sulbactam

Interventions

Cefepime 1000 MGDRUG

Cefepime is a fourth-generation cephalosporin antibiotic

Also known as: maxipime
Cefepime Group
Ampicillin-sulbactamDRUG

Broad-Spectrum Antibiotic

Also known as: unictam
Ampicillin/Sulbactam

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women within age group more than18 years.
  • Pregnant women with elective cesarean delivery.
  • Previous and primary cesarean delivery.

You may not qualify if:

  • Severe hepatic disease women Emergent cesarean deliveries. Women with medical disorders as pre-gestational diabetes, anemia, hypertension, or preeclampsia.
  • Women who had a skin infection adjacent to the operative site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

MeSH Terms

Conditions

InfectionsSurgical Wound Infection

Interventions

Cefepimesultamicillin

Condition Hierarchy (Ancestors)

Wound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Beni-Suef University

    Faculty of Medicine Beni-Suef University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Study Record Dates

First Submitted

September 16, 2023

First Posted

September 21, 2023

Study Start

January 1, 2023

Primary Completion

September 15, 2023

Study Completion

September 20, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

EG(1)