Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-09-20

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Cesarean Section; Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Cefepime Group

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

Group Type EXPERIMENTAL

Cefepime 1000 MG

Intervention Type DRUG

Cefepime is a fourth-generation cephalosporin antibiotic

Ampicillin/Sulbactam

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

Group Type ACTIVE_COMPARATOR

Ampicillin-sulbactam

Intervention Type DRUG

Broad-Spectrum Antibiotic

Interventions

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Cefepime 1000 MG

Cefepime is a fourth-generation cephalosporin antibiotic

Intervention Type DRUG

Ampicillin-sulbactam

Broad-Spectrum Antibiotic

Intervention Type DRUG

Other Intervention Names

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maxipime unictam

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No