Methods |
RCT; 2 parallel groups. |
|
Unit of randomization: individual. |
Participants |
Dates of data collection; not reported. |
|
Setting: University of Michigan Medical Center, Ann Arbour, Michigan, US |
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Inclusion criteria: women in labor. |
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Exclusion criteria: acute bleeding due to abruptio placentae, infection on treatment; abnormal renal function, penicillin allergy |
Interventions |
Cephalothin 2 g IV within 1 hour of operation and at 4 and 8 hours after (N = 40) vs comparable appearing placebo (N = 40) |
Outcomes |
Febrile morbidity (oral temperature > 100.3°F twice 6 hours apart); infection of endometrium, urinary tract and wound (definitions not provided); fever index (40 degree hours for treatment group vs 83 for placebo group) |
Notes |
Class of antibiotic: first generation cephalosporin. |
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Subgroups:
non-elective CS;
before cord clamping.
|
Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Unclear |
Selected in random …manner”. No further information provided. |
Allocation concealment? |
Unclear |
No information provided. |
Blinding? |
Yes |
Double blind, placebo controlled. |
All outcomes |
|
“The placebo was comparable to the cephalothin in both appearance and viscosity of solution.” |
Incomplete outcome data addressed? |
Unclear |
No loss to follow up or exclusion of participants after randomization described, but results of only 80/85 participants reported Insufficient detail to know if the analysis was ITT. |
All outcomes |
|
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The 2 groups were comparable, but insufficient information overall |
Overall low risk of bias? |
Unclear |
Mostly unclear. |