Methods |
RCT; 2 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: February to July 1991. |
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Setting: Sousse Hospital, Tunisia. |
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Inclusion criteria: women undergoing elective CS or labor < 12 hours (categorized as ”both“ for this review” |
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Exclusion criteria: diagnosed amniotic infection; pyrexia >38°C; antibiotics within 3 days; allergy to beta lactam antibiotics; cardiac disease; diabetes |
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Interventions |
Cephapirine 1 g IV with induction of anesthesia and 6 hours after operation, gentamycin 80 mg IM with induction, metronidazole 500 mg IV with induction (N = 133), vs no treatment (N = 136) |
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Outcomes |
Endometritis; wound infection; pyrexia only (> 38°C 48 hours after surgery): antibiotic 4/133 vs control 9/136; septicemia (0/133 vs 3/136, included as serious morbidity); duration of hospital stay (antibiotic 5.36 days vs control 6.21, P = 0.03, variance not given) |
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Notes |
Follow up at 30 days (86%). |
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Translated from French. |
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Class of antibiotic: first generation cephalosporin, aminoglycoside and nitroimidazole (metronidazole) |
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Subgroups: |
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Risk of bias |
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Item |
Authors’ judgement |
Description |
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Adequate sequence generation? |
Unclear |
Allocation “by chance”. |
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Allocation concealment? |
Unclear |
Using random number table, patients allocated to treatment if the number is even, no treatment if the number is odd |
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Blinding? |
No |
Not placebo controlled. |
All outcomes |
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|
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Incomplete outcome data addressed? |
Unclear |
No losses or exclusions reported. It appears to be ITT analysis |
All outcomes |
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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 similar for age, parity, duration of labor and other risk factors. There was insufficient other information to judge |
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Overall low risk of bias? |
Unclear |
Overall unclear. |