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

Rajavithi Hospital

Status: Completed

Conditions: Febrile Morbidity After Emergency Cesarean Section

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05647993

65094

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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172 participants in 2 patient groups, including a placebo group

Control group (Placebo)

Placebo Comparator group

Description:

Patient will receive standard antimicrobial prophylaxis(cefazolin intravenously weight dependent) and placebo(0.9% NaCl 100 ml intravenously) before the incision

Treatment:

Drug: Sodium Chloride 0.9% Intravenous Solution

Drug: Cefazolin

azithromycin

Experimental group

Description:

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

Treatment:

Drug: Azithromycin Injection [Zithromax]

Drug: Cefazolin