Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections

Phase 3

Active, not recruiting

• Conditions: Cesarean Section; Infection
• Interventions: Drug: Cefepime 1000 MG; Drug: Ampicillin-sulbactam

• Registration Number: NCT06048692
• Lead Sponsor: Beni-Suef University

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.

Detailed Description

A prospective randomized clinical study conducted in the department of obstetrics and gynecology of Beni-Suef University Hospital . A total of 213 women were assessed for eligibility, 13 of which were excluded. A total of 200 pregnant women who were eligible for elective cesarean sections (CS). The overall median duration of postoperative followed up was from 10 days to one month to determine the surgical site infection (SSI).

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-09
• Primary Completion: 2023-09-15
• Study First Submitted: 2023-09-16
• Study First Submitted QC: 2023-09-16
• Last Update Submitted: 2023-09-16
• Study Completion: 2023-09-20
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 213

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefepime Group	Cefepime 1000 MG	Pregnant women (n=100) received IV cefepime (CEF) (maxipime®1000mg) 30 minutes before cesarean delivery (CD) and 12 hours after CD
Ampicillin/Sulbactam	Ampicillin-sulbactam	Pregnant women (n=100) received IV Ampicillin/Sulbactam (AMS) (Unictam® 1500 mg) 30 minutes before CD and 12 hours after CD

Primary Outcome Measures

Name	Time	Method
surgical site infection	1 month	pain, redness, swelling, warm skin around the wound, yellow or green discharge

Trial Locations

Locations (1)

Beni-suef university Hospital; 🇪🇬 Banī Suwayf, Beni Suef, Egypt