Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections

Beni-Suef University

Status and phase: Active, not recruiting; Phase 3

Conditions: Cesarean Section; Infection

Treatments: Drug: Ampicillin-sulbactam; Drug: Cefepime 1000 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06048692

maxipime in cs

Details and patient eligibility

About

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.

Full 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).

Enrollment: 213 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

213 participants in 2 patient groups

Cefepime Group

Experimental group

Description:

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

Treatment:

Drug: Cefepime 1000 MG

Ampicillin/Sulbactam

Active Comparator group

Description:

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

Treatment:

Drug: Ampicillin-sulbactam