Methods |
Randomized, placebo-controlled trial; 2 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dates of data collection: May 1982-August 1983. |
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Setting: South Saimaa Central Hospital, Lappeenranta, Finland |
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Inclusion criteria: initially all women undergoing CS (N = 80); thereafter women undergoing non-elective (ruptured membranes) section (N = 72) |
Interventions |
Tinidazole 500 mg IV at cord clamping (N = 75) vs identical placebo (N = 77) |
Outcomes |
Febrile morbidity (> 38°C on 2 post-operative days, excluding the first); endometritis (fever, foul lochia or uterine tenderness); wound infection (fever, cellulitis or exudate); UTI (fever and positive culture) |
Notes |
Authors’ definition of non-elective (ruptured membranes) and elective (unruptured membranes) not consistent with the definitions used in this review; classified in this review as ‘both’. |
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Newborn infants observed for effects of tinidazole (although data not given) |
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Class of antibiotic: nitroimidazole (tinidazole). |
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Subgroups:
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Unclear |
‘Randomized according to a code.’ |
Allocation concealment? |
Yes |
“Identical vials … coded from 1 to 160.” |
Blinding? |
Yes |
Placebo-controlled, double blind. |
All outcomes |
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“The code was first opened when the study was completed.” |
Incomplete outcome data addressed? |
Unclear |
No loss to follow up reported. |
All outcomes |
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8 women excluded: 4 because they were febrile before the operation, 4 because of mistakes in administration; data not provided to perform ITT analysis |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The 2 groups were comparable regarding age, weight, gestational age, etc. There was insufficient other information which to judge |
Overall low risk of bias? |
Unclear |
Mostly unclear. |