Methods |
Randomized, placebo controlled trial; 2 parallel groups. |
|
Unit of randomization: individual. |
|
Participants |
Dates of data collection: August 1970 - January 1971. |
|
Setting: Johns Hopkins University, Baltimore, US; |
|
Inclusion criteria: women undergoing CS (criteria not specified) |
|
Exclusion criteria: evidence of clinical infection, history of penicillin allergy |
|
Interventions |
Cephalothin 1 g IV on call to operating room, further 2 g IV intra-operatively and every 6 hours for 48 hours, then 500 mg IM for additional 72 hours (N = 5) vs placebo (N = 7) |
|
Outcomes |
Morbidity (temperature > 100.9°F twice, 6 hours apart after first 48 hours or other clinical signs of infection); not separated. For this review, the authors’ definition of morbidity has been classified as fever |
|
Notes |
Part ofa larger randomized trial ofprophylactic antibiotics in gynecologic surgery; most patients (87%) were undergoing hysterectomy; only 12/300 patients enrolled underwent CS |
|
Class of antibiotic: first generation cephalosporin. |
|
Subgroups: |
|
type of CS unclear;
before cord clamping.
|
|
Risk of bias |
|
Item |
Authors’ judgement |
Description |
|
Adequate sequence generation? |
Unclear |
“Randomized.” |
|
|
No additional information. |
|
Allocation concealment? |
Yes |
Randomized list ofplacebo or drug, kept in hospital pharmacy; code not broken until after patient classified as ‘morbid’ or ‘non-morbid’ |
|
Blinding? |
Yes |
Described as “double-blind”. |
All outcomes |
|
Placebo-controlled. |
|
Incomplete outcome data addressed? |
Yes |
No loss to follow up. |
All outcomes |
|
No participants excluded. |
|
|
ITT analysis. |
|
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
|
Free of other bias? |
Unclear |
No information was provided. |
|
Overall low risk of bias? |
Unclear |
Insufficient information to judge. |