| Methods |
Randomized trial
Study period: not stated |
| Participants |
Inclusion criteria: postcesarean at least 12 hours postoperative who had received 3 doses of cefazolin as prophylaxis, and who presented with uterine tenderness, temperature at least 38.3 °C on 1 occasion or at least 38 °C on 2 occasions at least 6 hours apart, and no other obvious source of infection
Setting: Philadelphia, Pennsylvania, USA
Number of participants: n = 140 |
| Interventions |
Cefotetan 2 g iv every 12 hours (plus placebo doses; n = 66) vs cefoxitin 2 g iv every 6 hours (n = 63) |
| Outcomes |
Therapeutic failure (defined as a lack of decrease in temperature and uterine tenderness within 48 hours of therapy)
Incidence of enterococcal bacteremia (considered automatically as a treatment failure): cefotetan n = 3; cefoxitin n = 1
Relapse (defined as those women meeting criteria for cure with subsequent wound infection, abscess, recurrent endometritis within 6 weeks) ‐ 1 in each group
Complications (wound infection)
Diarrhea |
| Notes |
11 women were excluded due to protocol violations (4 from cefotetan group, 7 from the cefoxitin group)
Pharmaceutical sponsorship ‐ probable
All participants were postcesarean birth |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computerized randomization schedule |
| Allocation concealment (selection bias) |
Low risk |
Pharmacy controlled randomization |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double blinded. All doses were identical in appearance and were dispensed from the pharmacy |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
All clinical decisions made by the primary physicians, not by the study team |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
11 (7.8%) women were excluded due to protocol violations (4 from cefotetan group, 7 from the cefoxitin group) |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol is not available, insufficient information to permit judgment |
| Other bias |
Low risk |
The study appears to be free of other sources of bias |
