Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic During Emergency Intrapartum Cesarean Section

Phase 2

• Conditions: Emergency Cesarean Section; Infection Wound
• Interventions: Drug: Cefepime; Drug: Cefuroxime plus Metronidazole

• Registration Number: NCT04009772
• Lead Sponsor: Assiut University

Brief Summary

Compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care

Detailed Description

This is a randomized double blinded study which compare between single dose cefepime versus cefuroxime plus metronidazole during emergency intrapartum cesarean section.

Outcomes will include fever, wound infection, and urinary tract infection.

Study Timeline

• Status Verified: 2019-07
• Study Start: 2019-07-01
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-03
• Last Update Submitted: 2019-07-03
• Study First Posted: 2019-07-05
• Last Update Posted: 2019-07-05
• Primary Completion: 2020-02-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• intrapartum caesarean section

Exclusion Criteria

• evidence of infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Cefepime" , "Maxipime®" 1 gm	Cefepime	Patient will receive "Cefepime" ,"Maxipime®" 1 gm IV during cesarean section just before skin incision
"Cefuroxime", "Zinnat®" 1gm plus "metronidazole"Flagyl®" 500	Cefuroxime plus Metronidazole	Patient will receive "Cefuroxime", "Zinnat®" 1gm ,and "metronidazole"Flagyl®" 500 IV; just before skin incision for emergency cesarean section

Primary Outcome Measures

Name	Time	Method
Incidence of surgical site wound infection	one week	Examining the wound after one week of the surgery to detect any infection

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt