Methods |
Randomized trial
Study period: November 1993 through May 1994 |
Participants |
Inclusion criteria: women with postpartum endometritis defined as temperature of at least 38 °C on 2 occasions separated by at least 4 hours after the first 24 hours postpartum without evidence of other foci of infection. All were postcesarean birth
Setting: military hospital, Mexico
Number of participants: n = 77 |
Interventions |
Penicillin 10 million units iv every 4 hours plus amikacin 500 mg iv every 12 hours until afebrile for 24 hours then oral and IM to complete 10 days (n = 31) vs same iv regimen until afebrile 48 hours with no further treatment (n = 32) |
Outcomes |
Therapeutic failure
Mean length of stay
Amount of drug utilized |
Notes |
All participants were postcesarean birth
Pharmaceutical sponsorship ‐ none apparent |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomization reported, no method specified |
Allocation concealment (selection bias) |
Unclear risk |
No allocation method reported |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
No blinding here due to length of treatment, unlikely effecting outcome |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
No description of blinding data abstractor in the English translation |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
8 patients in group A and 7 in group B were excluded. Would have been better to maintain in the study for intention‐to‐treat analysis |
Selective reporting (reporting bias) |
Unclear risk |
Specific outcomes not reported in translated article |
Other bias |
Unclear risk |
Only a reduced translated copy of the review is available which could lead to information about potential biases being missed |