Methods |
Randomized trial
Study period: not stated |
Participants |
Inclusion criteria: women with puerperal infection based on standard febrile morbidity; uterine, parametrial, or vaginal cuff tenderness; and leukocytosis
Setting: New Orleans, Louisiana, USA
Number of participants: n = 60 |
Interventions |
Moxalactam 2 g iv every 8 hours (n = 29) vs clindamycin 600 mg iv every 6 hours plus tobramycin 1 mg/kg‐1.5 mg/kg iv every 8 hours (n = 31) |
Outcomes |
Treatment failure
Pelvic abscess (severe complication)
Wound abscess
Diarrhea |
Notes |
Diarrhea was a complication regarded as clinical failure with change of antibiotic regimen. This case not included in our analysis of therapeutic failure
Pharmaceutical sponsorship ‐ probable
Information on number of cesarean or vaginal births was not provided |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer‐generated random number table |
Allocation concealment (selection bias) |
Unclear risk |
No discussion of method for allocation concealment |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
No discussion of blinding was reported |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
No discussion of blinding was reported |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No drop‐outs |
Selective reporting (reporting bias) |
Unclear risk |
The protocol is not available, insufficient information to permit judgment |
Other bias |
Low risk |
Study appeared to be free of other sources of bias |