Methods |
RCT; 2 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: June - September 1979. |
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Setting: National Women’s Hospital, Auckland, New Zealand. |
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Inclusion criteria: all women undergoing CS (8/73 were repeat) |
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Exclusion: already on antibiotics. |
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Interventions |
Metronidazole 500 mg IV prior to incision and metronidazole 2 g suppository at end of surgery (N = 35) vs matching placebo infusion and suppository (N = 38) |
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Outcomes |
Fever (> 37.9°C within 14 days of delivery); wound infection, endometritis, UTI, major complication (return to theatre or hospitalised >10 days because of post-operative morbidity); need for antibiotic therapy (treatment 13 vs placebo 10); fever index (257 degree hours vs 165 hours) |
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Notes |
1 major complication (not infectious) in each group (bleeding from lower segment in 1, major deep vein thrombosis extending into iliac veins in another) |
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Drug class: nitroimidazole (metronidazole). |
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Subgroups: |
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type of CS unclear;
before cord clamping.
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Risk of bias |
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Item |
Authors’ judgement |
Description |
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Adequate sequence generation? |
Unclear |
“Randomized.” |
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No additional information. |
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Allocation concealment? |
Unclear |
No information was provided. |
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Blinding? |
Yes |
Double-blind, placebo-controlled. |
All outcomes |
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|
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Incomplete outcome data addressed? |
Yes |
No losses 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 age and weight. There was insufficient other information which to judge |
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Overall low risk of bias? |
Unclear |
Mostly unclear. |