Clinical trial

The Impact of Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections

Name

maxipime in cs

Description

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 arms

Trial start

2023-01-01

Estimated PCD

2023-09-15

Trial end

2023-09-20

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Cefepime 1000 MG

Cefepime is a fourth-generation cephalosporin antibiotic

Arms:

Cefepime Group

Other names:

maxipime

Ampicillin-sulbactam

Broad-Spectrum Antibiotic

Arms:

Ampicillin/Sulbactam

Other names:

unictam

Size

213

Primary endpoint

surgical site infection

1 month

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 213, 'type': 'ACTUAL'}}

Updated at

2023-09-21

1 organization

2 products

1 indication

Organization

Product

Indication

Product