Clinical trial NCT05647993: Comparing of Cefazolin Plus Azithromycin Versus Cefazolin in Prevention of Febrile Morbidity After Emergency Cesarean Delivery
Official title: Comparing of Cefazolin Plus Azithromycin Versus Cefazolin Alone in Prevention of Febrile Morbidity After Emergency Cesarean Delivery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Febrile Morbidity After Emergency Cesarean Section
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2022-12-13
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of febrile morbidity at postoperative day 3
timeFrame: postoperative day 3
Secondary outcomes:
measure: adverse drug effect
timeFrame: baseline and postoperative day 3, 7 and 30
measure: Incidence of adverse Neonatal outcome
timeFrame: baseline and postoperative day 3, 7 and 30
measure: Incidence of febrile morbidity at postoperative day 7 and day 30
timeFrame: postoperative day 7 and day 30
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References: