| Methods |
Randomized trial
Study period: February 1991 through March 1993 |
| Participants |
Inclusion criteria: clinical diagnosis of postpartum endometritis (defined as temperature of at least 38 °C orally on 2 occasions or at least 39 °C on 1 occasion, uterine tenderness, absence of any other source of infection), serum creatinine less than 1.4 mg/dL
Setting: Chicago, Illinois, USA
Number of participants: n = 142 |
| Interventions |
Gentamicin 5 mg/kg of body weight iv once daily (n = 62) vs gentamicin every 8 hours with dosing adjustments based on peak and trough blood levels (n = 65)
Other antibiotics allowed |
| Outcomes |
Duration of fever (20.8 hours vs 23.7 hours); post‐treatment serum creatinine levels; nephrotoxicity (not defined further)
Change of initial regimen (14/62 vs 17/65)
Pharmacy (USD 16.12 vs USD 41.75) and nurse labor costs; length of stay |
| Notes |
15 of the women enrolled were excluded for protocol violations; administrative errors, misdiagnosis, concomitant infection; no data on treatment allocation to include in intention‐to‐treat analysis
Cesarean births = 78
Pharmaceutical sponsorship ‐ none apparent |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random numbers table via sealed envelopes |
| Allocation concealment (selection bias) |
Low risk |
Used sealed opaque envelopes |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
“The managing clinical service and the subjects were blinded to the gentamicin treatment regimen.” |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not stated |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
“A total of 142 subjects were randomized. Fifteen were excluded from analysis because of study‐protocol violations: three had concomitant infections, three had a misdiagnosis of endometritis, and nine had administrative errors. A total of 127 subjects remained for analysis: 62 in the study group and 65 in the control group” – about 89% of data available, well‐balanced between the 2 arms and the majority of reasons for missing data are unlikely to be related to true outcome (apart from possibly 6 patients (4%) with concomitant infections or with a misdiagnosis) |
| Selective reporting (reporting bias) |
Low risk |
Protocol available and all of the study’s pre‐specified outcomes have been reported |
| Other bias |
Low risk |
Study appeared to be free of other sources of bias |
