| Methods |
Randomized trial
Study period: December 1984 through April 1986 |
| Participants |
Inclusion criteria: postpartum women with temperature of 100.4 °F (38 °C) or greater, uterine tenderness, no other source of fever identified
Setting: St Louis, Missouri, USA
Number of participants: n = 62 |
| Interventions |
Aztreonam 1 g‐2 g iv every 8 hours plus clindamycin 900 mg iv every 8 hours (n = 31) vs gentamicin ("per manufacturer's instructions") every 8 hours plus clindamycin 900 mg iv every 8 hours (n = 31) |
| Outcomes |
Cure (defined as defervescence and complete resolution of signs and symptoms) or partial response (defined as "substantial or temporary improvement") or therapeutic failure
Mortality
Side‐effects including abnormal laboratory findings, pruritus following drug administration, pain and phlebitis at infusion site |
| Notes |
45 women had cesarean births and 17 had vaginal births
All women given oral antibiotics to complete a 10‐14 day course
Pharmaceutical sponsorship ‐ explicit |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
States "randomly assigned" according to a schedule provided by the sponsoring company, 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 judgment |
| Other bias |
High risk |
Pharmaceutical sponsorship ‐ explicit |
