| Methods |
Randomized trial
Study period: not stated |
| Participants |
Inclusion criteria: women postcesarean who had received prophylactic cefazolin (3 doses) with temperature of at least 38.3 °C that occurred 24 hours after the last dose of cefazolin, marked uterine tenderness, and at least 1 of the following; tachycardia, white blood count of at least 14,000 or at least 10% increase in immature polymorphonuclear leukocytes
Setting: Houston, Texas, USA
Number of participants: n = 70 |
| Interventions |
Sulbactam 1 g with ampicillin 2 g iv every 6 hours (n = 34) vs metronidazole 500 mg iv every 6 hours with gentamicin every 8 hours adjusted by peak and trough levels (n = 36) |
| Outcomes |
Therapeutic failure (defined as lack of resolution of all signs and symptoms of infection within 72 hours) |
| Notes |
All participants were women postcesarean who had received 3 doses of cefazolin as prophylaxis
Oral antibiotics were not given
Pharmaceutical sponsorship ‐ probable
3 women excluded because they had vaginal births (2 in sulbactam/ampicillin group; 1 in metronidazole/gentamicin group) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
States “randomized” without further description |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Not stated |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not stated |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
3 women excluded because they had vaginal births (2 in sulbactam/ampicillin group; 1 in metronidazole/gentamicin group)
Drop‐outs < 5% |
| 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 |
