Methods |
RCT, 2 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: March - October 1982. |
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Setting: A Meir General Hospitla, Kfar Sava, Israel. |
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Inclusion criteria: patients undergoing CS, classified as “no-labor” if cesarean was performed before onset of labor and “labor” if occurred after onset of labor |
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Exclusion criteria: evidence of infection, known allergy to penicillin, antibiotic therapy during the previous 2 weeks |
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Interventions |
Mezlocillin 2 g IV 30 minutes before surgery, then 4 and 9 hours after surgery vs placebo IV 30 minutes before surgery, then 4 and 9 hours after surgery |
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Outcomes |
Febrile morbidity (2 oral temperatures > 38°C at least 4 hours apart after the first 24 hours); endometritis (fever and uterine tenderness with or without a positive lochial culture and no other apparent cause of fever); UTI (> 105 colonies/ml after a negative pre-operative culture); wound infection (fever, cellulitis, exudate and tenderness) |
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Notes |
Class of antibiotic: ureidopenicillin (mezlocillin). |
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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 |
“Patients were randomly assigned.” |
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Method not described. |
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Allocation concealment? |
Unclear |
No information. |
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Blinding? |
Unclear |
Placebo controlled. |
All outcomes |
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Insufficient information to judge whether there was blinding of study personnel |
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Incomplete outcome data addressed? |
Unclear |
7 patients were excluded for errors in following the protocol |
All outcomes |
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Excluded patients not included in analysis; data cannot be imputed |
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
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Free of other bias? |
Unclear |
“The groups did not differ significantly in obstetrical variables…indications for CS were similar in both groups.” Insufficient other information to judge. |
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Overall low risk of bias? |
Unclear |
Mostly unclear. |