| Methods |
Randomized trial
Study period: November 1982 through December 1983 |
| Participants |
Inclusion criteria: women with postcesarean birth endometritis defined as an oral temperature of at least 38 °C, uterine tenderness and without other sources of fever
Setting: San Antonio, Texas, USA
Number of participants: n = 119 |
| Interventions |
Aztreonam 2 g every 8 hours plus clindamycin 600 mg iv every 6 hours (n = 58) vs gentamicin iv dosed by body weight every 8 hours plus clindamycin 600 mg iv every 6 hours (n = 61) |
| Outcomes |
Therapeutic failure (lack of resolution of signs and symptoms within 72 hours)
Side‐effects (diarrhea, allergy) leading to discontinuation of treatment
Length of hospital stay |
| Notes |
All participants had cesarean births
Pharmaceutical sponsorship ‐ explicit |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Randomization schedule provided by pharmaceutical sponsor |
| 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 |
States “119 patients were evaluated”, but number randomized not stated, so insufficient information to permit judgement |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol is not available, insufficient information to permit judgment |
| Other bias |
High risk |
Pharmaceutical sponsorship ‐ explicit |
