Cefazolin alone versus cefazolin, gentamicin, and metronidazole for prophylaxis in women undergoing caesarean section: a randomised controlled trial

Abstract

BackgroundProphylactic antibiotic regimens for women undergoing caesarean section are useful for prevention of maternal morbidity, and antibiotic misuse can give rise to antimicrobial resistance. The aim of this study was to compare a single preoperative dose of cefazolin with the current standard practice of cefazolin, gentamicin, and metronidazole three times daily after the caesarean section until patient discharge. MethodsIn this randomised, unmasked, parallel-group controlled trial, we enrolled women (aged 18–45 years) who were undergoing a caesarean section at the Al-Helal Al-Emirati Hospital in Rafah, Gaza Strip, occupied Palestinian territory. Using manual-blocks formation based on the rolling of a die, recruited women were randomly assigned to either 1000 mg intravenous cefazolin 30–60 min before the caesarean section (cefazolin group) or 1000 mg cefazolin, 80 mg gentamicin, and 500 mg metronidazole three times daily after the caesarean section until hospital discharge (triple antibiotic group). Outcome measures included readmission to the hospital because of wound infection, registered post-caesarean complications, duration of the caesarean section procedure, and length of hospital stay. Data were analysed with SPSS. Groups were compared using student's t test or χ2 test. The study was approved by the Ministry of Health of the Gaza Strip and done in accordance with the Declaration of Helsinki. Women provided verbal informed consent before participation in the trial and before undergoing the caesarean section. FindingsBetween Jan 1, 2013, and July 31, 2013, we screened 329 women and enrolled 313 (mean age 31·2 years [SD 6·5]). We excluded 26 women because of previous infections (n=12), history of drug allergy (n=5), and missing data (n=9). 158 women were assigned to the cefazolin group, and 155 women assigned to the triple antibiotic group. Four women were readmitted to the hospital because of wound infections (three [2%] women from the cefazolin group, one [1%] from the triple antibiotic group; p=0·375). Mean duration of the caesarean section procedure was 35·86 min (SD 7·77) in the cefazolin group and 36·70 min (7·40) in the triple antibiotic group (p=0·511). Mean length of hospital stay after the caesarean section was 39·62 h (SD 11·19) in the cefazolin group and 40·48 h (13·07) in the triple antibiotic group (p=0·672). No cases of endometritis, urinary tract infections, or febrile morbidities were reported. InterpretationPre-caesarean, single-dose cefazolin was as effective as the combination of cefazolin, gentamicin, and metronidazole in preventing post-caesarean infections. We therefore recommend that cefazolin is used pre-operatively to prevent post-caesarean infection. FundingNone.