Hemsell 1983.
| Methods | Randomized trial Study period: May 1980 through March 1981 | |
| Participants | Inclusion criteria: women with postcesarean birth endometritis defined as temperature of at least 38.3 °C on 2 occasions 4 hours or more apart, abdominal pain with abdominal, uterine and perhaps parametrial tenderness Setting: university hospital, Dallas, Texas, USA Number of participants: n = 120 | |
| Interventions | Cefotaxime 2 g iv every 8 hours (n = 81) vs clindamycin 600 mg iv every 6 hours plus gentamicin 1 mg/kg every 8 hours (n = 39) | |
| Outcomes | Treatment failure Complications including pelvic abscess (severe complication), wound infection, and diarrhea Length of treatment was 5.5 +/‐ SD 2.1 days versus 5.6 +/‐ SD 1.9 days | |
| Notes | All participants were postcesarean births Although not specifically stated, the earlier citation appears to include women included in the later citation Pharmaceutical sponsorship ‐ probable | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomized by computer‐generated list 2:1 |
| 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 | Unclear risk | In dose‐finding study 117(99.2%) of 118 patients completed treatment. “Two women treated early in the study were excluded from group 1. One woman [..] was included in group 2. The second woman was excluded when she developed cellulitis at the site of intramuscular injection and cefotaxime therapy was discontinued.” In comparative phase, 120 women treated, but number randomized is not stated Insufficient information to permit judgement |
| Selective reporting (reporting bias) | Unclear risk | The protocol is not available, insufficient information to permit judgement |
| Other bias | Unclear risk | Study appeared to be free of other sources of bias, however pharmaceutical sponsorship is suspected |