Methods |
‘Randomly divided’ (no details provided); placebo-controlled |
|
Participants |
Dates of data collection: December 1981 to August 1982. |
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Setting: School of Midwifery, Helsinki, Finland. |
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Inclusion criteria: women undergoing CS; elective CSs not included but definition not provided |
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Exclusion: antibiotics prior to procedure. |
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Interventions |
Metronidazole 500 mg IV after cutting of cord (N = 109) vs placebo (N = 110) |
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Outcomes |
Wound infection, endometritis, sepsis (temperature > 38.5°C and bacteremia). |
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Notes |
Translated from German. |
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Class of antibiotic: nitroimidazole (metronidazole). |
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Subgroups: |
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type of CS unclear;
after cord clamping.
|
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Risk of bias |
|
Item |
Authors’ judgement |
Description |
|
Adequate sequence generation? |
Unclear |
“Randomly” divided into 2 groups. |
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Allocation concealment? |
Unclear |
No information provided. |
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Blinding? |
Unclear |
No details provided. |
All outcomes |
|
|
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Incomplete outcome data addressed? |
Unclear |
No losses or exclusions reported; it appears the analysis was ITT |
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 comparable in respect of social status, age, parity, duration of pregnancy, primary section/repeat section, axillary temperature before the procedure, localization of skin incision, number of am-nioscopes. There was insufficient other information which to judge |
|
Overall low risk of bias? |
Unclear |
Overall unclear. |