Methods |
RCT; 3 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: initiated March 1981. |
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Setting: Charlottesville, Virginia, USA, almost all were indigent women |
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Inclusion criteria: both ‘low risk’ (labor < 6 hours) and ‘high risk’ (> 6 hours) women undergoing CS |
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Exclusion criteria: allergy to penicillin or cephalosporin; antibiotic use within 7 days; antibiotics required for other reasons; pyrexia >38° C; foul amniotic fluid. |
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Interventions |
Irrigation of the uterus and peritoneal cavity with 2 g cefamandole in 1000 ml normal saline (N = 73), vs saline placebo (N = 75) vs no irrigation group (N = 44). As the objective of this review is to compare antibiotic with no antibiotic, rather than the effect of irrigation, only the first 2 groups are compared (double blind comparison) |
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Outcomes |
Metritis (pyrexia >38°C twice 8 hours apart, after 24 hours plus abnormal uterine tenderness, without another apparent source); duration of maternal stay (treatment 5. 29 days vs placebo 6.32 days, variance could not be calculated) |
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Notes |
Authors’ definition of low and high risk do not correspond to those used for elective/ non-elective in this review. |
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No treated patients developed evidence of drug reaction. |
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There were no serious infections (pelvic abscess or phlebitis) in either group |
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Class of antibiotic: second generation cephalosporin. |
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Subgroup: |
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Risk of bias |
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Item |
Authors’ judgement |
Description |
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Adequate sequence generation? |
Yes |
’A computer generated table of random numbers.” |
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Allocation concealment? |
Yes |
”Assigned under the direction of the hospital pharmacy.” |
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Blinding? |
Yes |
Partially double blind placebo-controlled (3 groups: antibiotic irrigation, saline placebo irrigation, no irrigation). Physicians were unaware ofthe type ofirrigation used |
All outcomes |
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Incomplete outcome data addressed? |
Yes |
No loss to follow up reported. |
All outcomes |
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No participants excluded. |
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ITT analysis. |
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
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Free of other bias? |
Unclear |
The groups were comparable regarding gra-vidity, parity, maternal weight, hematocrit, etc. There was insufficient other information which to judge |
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Overall low risk of bias? |
Yes |
Good sequence generation, concealment allocation, blinding and complete outcome data |