| Methods |
Randomized trial
Study period: not given |
| Participants |
Inclusion criteria: postcesarean birth with endometritis diagnosed based on elevated temperatures and white count and abnormal uterine tenderness
Setting: South Carolina, USA
Number of participants: n = 21 |
| Interventions |
Trospectomycin 500 mg iv every 8 hours plus aztreonam 1 g iv every 8 hours (n = 12) vs clindamycin 900 g iv every 8 hours plus aztreonam 1 g iv every 8 hours (n = 8) |
| Outcomes |
Therapeutic failure (defined as lack of resolution of fever, uterine tenderness, and high white blood count) |
| Notes |
All participants were postcesarean birth
Pharmaceutical sponsorship ‐ explicit |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Code prepared by pharmaceutical company and carried out by hospital pharmacy. Did not state specific methods they used |
| Allocation concealment (selection bias) |
Low risk |
“Randomization code was prepared by the Upjohn (pharmaceutical) Company and was carried out by the (hospital) pharmacy.” It was a pharmacy controlled randomization |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
"The hospital pharmacy dispensed [antibiotics] to the floor in a double blind fashion.” |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
States they “undertook a small double blind study” with no further description given, indicating the outcome assessors were blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
20 (95.2%) patients completed treatment out of 21 patients enrolled. 1 patient “left against medical advice to be treated with oral antibiotics and was withdrawn from the study” |
| Selective reporting (reporting bias) |
Unclear risk |
The protocol is not available, insufficient information to permit judgement |
| Other bias |
High risk |
Pharmaceutical sponsorship explicit – “The Upjohn Company prepared the randomised code” |
