Methods |
RCT; 2 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dates of data collection: November 1975-June 1976. |
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Setting: Medical University Hospital of South Carolina; |
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Inclusion criteria: all women undergoing CS (51/97 not in labor; 61/97 without ruptured membranes) |
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Exclusion criteria: signs of infection, allergy to penicillin or cephalosporin, antibiotics within 2 weeks; lack of consent |
Interventions |
Cefazolin 1 g IV pre-operatively and at 2 and 8 hours post-operatively (N = 48) vs similar volume of placebo (N = 49) |
Outcomes |
Febrile morbidity (> 100.3oF twice on any of first 10 postpartum days after the first) ; endometritis (fever and uterine tenderness, or fever and pathogen from endometrium without other cause); UTI (fever or positive culture and symptoms); wound infection (fever, cellulitis and/or exudate) |
Notes |
Aerobic isolates unchanged, fewer anaerobes in patients given placebo; most pathogens isolated were resistant to cefazolin whether treatment or placebo given. |
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There were 2 episodes of septicemia (both in placebo group). |
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Class of antibiotic: first generation cephalosporin. |
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Subgroups:
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Unclear |
‘Random allocation.’ |
|
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No additional information. |
Allocation concealment? |
Unclear |
No information provided. |
Blinding? |
Unclear |
“A similar volume of placebo” was administered to the control group |
All outcomes |
|
No additional information. |
Incomplete outcome data addressed? |
No |
No loss to follow up reported. |
All outcomes |
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6 women initially randomized not included in analysis (non-adherence or noninfec-tious complications) |
|
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ITT analysis not performed; could not re-include data. |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The 2 groups were comparable regarding race, age and type of CS. There was insufficient other information which to judge |
Overall low risk of bias? |
Unclear |
Mostly unclear. |