Methods |
Randomized, double blind, placebo-controlled; 2 parallel groups |
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Unit of randomization: individual. |
Participants |
Dates of data collection: December 1983 to June 1985. |
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Setting: Chogoria Hospital, Kenya. |
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Inclusion criteria: all patients undergoing CS. |
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Exclusion criteria: clinical infection. |
Interventions |
Metronidazole 1 g rectal suppository 10-45 minutes before and 8 hours after procedure (N = 91) vs placebo suppository (N = 91) |
Outcomes |
Fever (> 37.9°C on at least 1 occasion); wound infection; mean febrile days (0.56 for treatment vs 1.23 for control), hospital days, any antibiotic use (18/91 vs 23/91) |
Notes |
Elective CS not defined. |
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No adverse events on mother or babies noted. |
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There was 1 grade 3 wound (defined as deep pelvic abscess or evidence of local or generalized peritonitis) in the treatment group as compared with 3 in the placebo group (classified as serious infectious morbidity) |
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Class of antibiotic: nitroimidazole (metronidazole). |
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Subgroups:
type of CS unclear;
before cord clamping.
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Unclear |
“…randomized…” |
Allocation concealment? |
Unclear |
No information was provided. |
Blinding? |
Yes |
Double-blind. |
All outcomes |
|
|
Incomplete outcome data addressed? |
Unclear |
7/189 patients initially randomized were not included in analysis because suppositories were incorrectly administered As treated analysis performed. |
All outcomes |
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The 2 groups were comparable regarding age, parity, duration of labor, duration ruptured membranes, number of vaginal examinations, etc. There was insufficient other information to judge |
Overall low risk of bias? |
Unclear |
Mostly unclear. |