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

Not Applicable

Completed

Interventions: Drug: Azithromycin Injection [Zithromax]
Drug: Cefazolin
Drug: Sodium Chloride 0.9% Intravenous Solution

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Singleton pregnancy with a gestation of 24 weeks or more
Undergoing non-elective cesarean delivery during labor or rupture of membrane more than 4 hr
No allergy to macrolide such as azithromycin and clindamycin
Provide informed consent
Partner of participant allows the patient to participate the research

Exclusion Criteria

Use of azithromycin within 7 days before enrollment
Chorioamnionitis or other infection requiring postpartum antibiotic therapy (except for antibiotics for group B streptococcus)
Liver disease (Cirrhosis or AST more than 3 times the upper normal limit)
Serum creatinine level of more than 2.0 mg/dL or need dialysis
Diarrhea at the time of enrollment
Maternal heart disease
Use of medication known to prolonged the QT interval

Arm && Interventions

Group	Intervention	Description
Control group (Placebo)	Sodium Chloride 0.9% Intravenous Solution	Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and placebo(0.9% NaCl 100 ml intravenously) before the incision
azithromycin	Azithromycin Injection [Zithromax]	Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and azithromycin 500 mg intravenously before the incision
Control group (Placebo)	Cefazolin	Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and placebo(0.9% NaCl 100 ml intravenously) before the incision
azithromycin	Cefazolin	Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and azithromycin 500 mg intravenously before the incision

Primary Outcome Measures

Name	Time	Method
Incidence of febrile morbidity at postoperative day 3	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)

Secondary Outcome Measures

Name	Time	Method
adverse drug effect	baseline and postoperative day 3, 7 and 30	Any adverse drug effect of azithromycin such as diarrhea, urticaria, and anaphylactic shock
Incidence of adverse Neonatal outcome	baseline and postoperative day 3, 7 and 30	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)
Incidence of febrile morbidity at postoperative day 7 and day 30	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)