Skip to main content
OpenTrials
Completed

NCT Number: NCT05647993

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Febrile Morbidity After Emergency Cesarean Section

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi Hospital

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin Injection [Zithromax]

Drug

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

Other names: azithromycin

Cefazolin

Drug

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.

Other names: azithromycin, placebo comparator

Sodium Chloride 0.9% Intravenous Solution

Drug

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

Other names: placebo comparator

Primary outcomes

  1. Incidence of febrile morbidity at postoperative day 3

    Time frame: 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 outcomes

  1. adverse drug effect

    Time frame: baseline and postoperative day 3, 7 and 30

    Any adverse drug effect of azithromycin such as diarrhea, urticaria, and anaphylactic shock

  2. Incidence of adverse Neonatal outcome

    Time frame: 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)

  3. Incidence of febrile morbidity at postoperative day 7 and day 30

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

Comparing of Cefazolin Plus Azithromycin Versus Cefazolin Alone in Prevention of Febrile Morbidity After Emergency Cesarean Delivery: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2022
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.