| Methods |
Randomized trial
Study period: February 1976 through October 1977 |
| Participants |
Inclusion criteria: women with diagnosis of postpartum endometritis based on fever and uterine tenderness
Setting: urban county hospital, Los Angeles, California, USA
Number of participants: n = 200 |
| Interventions |
Clindamycin 600 mg iv every 6 hours plus gentamicin 80 mg iv every 8 hours (n = 100) vs penicillin 5 million units iv every 6 hours plus gentamicin 80 mg iv every 8 hours (n = 100) |
| Outcomes |
Treatment failure (defined as those women whose therapy was not completed without problems)
Serious complications including pelvic abscess and need for addition of heparin
Wound infections
Rash (allergic reaction)
Diarrhea
Mean length of stay 7.4 days for clindamycin‐gentamicin vs 8.7 days for penicillin‐gentamicin (variance not given) |
| Notes |
All participants were postcesarean birth without prophylactic antibiotic treatment
Endometritis was defined vaguely
Pharmaceutical sponsorship ‐ none apparent |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
States "random basis" not further described |
| 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 |
Drop‐outs ‐ none |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol is not available, insufficient information to permit judgement |
| Other bias |
Low risk |
Study appeared to be free of other sources of bias |
