Methods |
Randomized, placebo-controlled trial; 3 parallel groups. |
|
Unit of randomization: individual. |
Participants |
Dates of data collection: September 1980 to November 1981. |
|
Setting: Hopital Saint-Luc, Montreal, Canada. |
|
Inclusion criteria: women undergoing non-elective CS. |
|
Exclusion criteria: not in labor with intact membranes, allergy to cephalosporins, antibiotic use within 48 hours, fever, ruptured membranes for > 36 hours |
Interventions |
Cefoxitin 2 g IV (N = 30) vs cefazolin 1 g IV (N = 30) vs placebo (N = 29) at clamping of the cord and at 6 and 12 hours later. Both treatment groups have been combined |
Outcomes |
Endometritis, wound infection, UTI (symptoms or two successive positive cultures) septicemia, pelvic abscess, pelvic thrombophlebitis. Follow up at 6 weeks. No side effects observed |
Notes |
There were no serious infections in any of the groups. |
|
In the placebo and cefazolin groups there was no increase in aerobic bacterial colonization of the cervix after 4 days but there was an increase in colonization by anaerobes; the opposite occurred in the group receiving cefoxitin |
|
Class of antibiotic: first generation cephalosporin vs second generation cephalosporin (cefamycin) |
|
Subgroups:
non-elective CS;
after cord clamping.
|
Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Unclear |
Randomized; method not described. |
Allocation concealment? |
Yes |
“A number (1 to 90) identified the boxes. The number was allocated randomly to a box.” |
|
|
An envelope containing the randomization code was available in case of adverse reactions |
Blinding? |
Yes |
Described as “double blind”. |
All outcomes |
|
Placebo-controlled: “vitamin solution with a similar colour as the other preparations” |
Incomplete outcome data addressed? |
Unclear |
No loss to follow up. |
All outcomes |
|
1 patient in the control group was excluded from analysis as no cultures were performed As treated analysis performed. |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The groups were comparable regarding demographic characters. |
Overall low risk of bias? |
Unclear |
Mostly unclear. |