Beningo 1986.
Methods | RCT. Individual women. Multi‐centre (6 centres). 2‐arm study. | |
Participants |
Inclusion criteria
Exclusion criteria
|
|
Interventions |
Intervention: cephalosporin (B2).
Comparison: penicillin (A3).
|
|
Outcomes | Satisfactory prophylactic response; febrile morbidity (temperature > 38 ºC x 2 occasions, 6 hours apart, not included first 24 hours post‐operation; wound infection). | |
Notes |
Setting: Women from hospitals and universities of San Francisco, Atlanta, Memphis, Los Angeles, Phoenix, New York. Subgroups
|
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “...a computer‐generated randomization schedule...” |
Allocation concealment (selection bias) | Low risk | “...a computer‐generated randomization schedule maintained by each hospital pharmacy...” |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | “The investigator and his (or her) staff were blinded as to antibiotic assignment. The code was not broken by the investigator until the last patient had been evaluated for prophylactic response.” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | · “The investigator and his (or her) staff were blinded as to antibiotic assignment. The code was not broken by the investigator until the last patient had been evaluated for prophylactic response.” |
Incomplete outcome data (attrition bias) All outcomes | High risk | Excluded after randomisation: cephalosporin group 30/177 (16.9%) and penicillin group 33/119 (19.5%). Also differential loss from two groups. |
Selective reporting (reporting bias) | Unclear risk | We did not assess trial protocol. |
Other bias | Unclear risk | Study not stopped early; similar baseline characteristics for weight; height & race, but significant difference in mean age ‐ though not considered important. Other aspects of bias were unclear. No information on funding source of study. |