An interventional study of Azithromycin Injection [Zithromax] and Cefazolin in Febrile Morbidity After Emergency Cesarean Section, sponsored by Department of Medical Services Ministry of Public Health of Thailand. Completed at 1 site in Thailand. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by Department of Medical Services Ministry of Public Health of Thailand · Not applicable, Interventional, and Treatment
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.
This study was designed to evaluate the effect of azithromycin on the incidence of febrile morbidity after the emergency cesarean section. The standard antimicrobial prophylaxis which is recommended by the ACOG is the 1st generation cephalosporin intravenously only but some of the bacteria that can cause the febrile morbidity after cesarean section wouldn't be killed by the 1st generation cephalosporin. The antibiotic that can cover them is macrolide group antibiotic such as azithromycin. Therefore this study will compare the regimen of standard antimicrobial prophylaxis and the regimen of standard antimicrobial prophylaxis with azithromycin intravenously in preventing the febrile morbidity after emergency cesarean section. Control group will receive the 1st generation cephalosporin intravenously and the intervention group will receive the 1st generation cephalosporin with azithromycin 500mg intravenously. Primary outcome is febrile morbidity which assessed at postoperative day 3. The definition of the febrile morbidity in this study is including surgical site infection, endometritis, urinary tract infection and fever alone. Secondary outcomes are febrile morbidity at postoperative day 7 and day30, neonatal outcome and adverse effect from azithromycin use.
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Exclusion Criteria:
Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and placebo(0.9% NaCl 100 ml intravenously) before the incision
Drug: Cefazolin · Drug: Sodium Chloride 0.9% Intravenous Solution
Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and azithromycin 500 mg intravenously before the incision
Drug: Azithromycin Injection [Zithromax] · Drug: Cefazolin
Intervention group patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and azithromycin 500 mg intravenously before the incision
Also known as: azithromycin
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.
Also known as: azithromycin, placebo comparator
For the placebo group will receive the cefazolin intravenously and 0.9% NaCl 100ml before the incision
Also known as: placebo comparator
Incidence of febrile morbidity at postoperative day 3
Patient will be assessed at postoperative day 3. Febrile morbidity is including surgical site infection, endometritis, urinary tract infection and fever. There is the questionnaire for the assessor to check if there is the febrile morbidity or not. (There are criteria diagnosis of febrile morbidity from the CDC in the questionnaire)
Time frame: postoperative day 3
adverse drug effect
Any adverse drug effect of azithromycin such as diarrhea, urticaria, and anaphylactic shock
Time frame: baseline and postoperative day 3, 7 and 30
Incidence of adverse Neonatal outcome
any adverse neonatal outcome such as NICU admission, neonatal sepsis, need phototherapy, respiratory distress, Apgar score, neonatal death and neonatal enterocolitis (Assessed and diagnosis by pediatric doctor)
Time frame: baseline and postoperative day 3, 7 and 30
Incidence of febrile morbidity at postoperative day 7 and day 30
Patient will be assessed at postoperative day 7 and day 30. Febrile morbidity is including surgical site infection, endometritis, urinary tract infection and fever. There is the questionnaire for the assessor to check if there is the febrile morbidity or not. (There are criteria diagnosis of febrile morbidity from the CDC in the questionnaire)
Time frame: postoperative day 7 and day 30
Plan to share: No
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Department of Medical Services Ministry of Public Health of Thailand