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Comparing of Cefazolin Plus Azithromycin Versus Cefazolin in Prevention of Febrile Morbidity After Emergency Cesarean Delivery

NCT05647993 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2024-01-25

No results posted yet for this study

Summary

Cesarean section is the common surgery in world wide. But the complication like febrile morbidity such as surgical site infection, fever, urinary tract infection and endometritis can be occurred even giving the standard antibiotics. Therefore if wider bacterial spectrum coverage antibiotic like azithromycin is added to the standard antimicrobial prophylaxis(1st generation cephalosporin), the incidence of febrile morbidity could be reduced. We will compare the regimen of cefazolin plus azithromycin and standard regimen of cefazolin alone in prevention of febrile morbidity after emergency cesarean section.

Conditions

  • Febrile Morbidity After Emergency Cesarean Section

Interventions

DRUG

Azithromycin Injection [Zithromax]

Intervention group patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and azithromycin 500 mg intravenously before the incision

DRUG

Cefazolin

All the participants will receive the cefazolin intravenously. The dosage of the cefazolin is depend on participant's weight. The participant with weight less than 80kg will receive cefazolin 1 gm and between 80-120kg will receive cefazolin 2 gm and for the participant with more than 120kg will receive cefazolin 3 gm before the incision.

DRUG

Sodium Chloride 0.9% Intravenous Solution

For the placebo group will receive the cefazolin intravenously and 0.9% NaCl 100ml before the incision

Sponsors & Collaborators

  • Department of Medical Services Ministry of Public Health of Thailand

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-14
Primary Completion
2023-11-30
Completion
2023-12-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05647993 on ClinicalTrials.gov