Gummerus 1984.
Methods | 'Randomly divided' (no details provided); placebo‐controlled. | |
Participants | Dates of data collection: December 1981 to August 1982. Setting: School of Midwifery, Helsinki, Finland. Inclusion criteria: women undergoing CS (average duration of labor 8 hrs 45 min; average duration of membrane rupture 6 hrs 48 min) N = 219. Exclusion: women undergoing elective CS (not defined further); antibiotics prior to procedure. |
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Interventions |
Intervention:
Comparison: placebo:
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Outcomes | Fever (temperature ≥ 38oC); wound infection, endometritis, sepsis (temperature > 38.5oC and bacteremia); abscess of pouch of Douglas (1 in each group). | |
Notes | Translated from German. Class of antibiotic: nitroimidazole (metronidazole). Subgroups:
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 amnioscopes. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly" divided into 2 groups. Comment: no description of sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no losses or exclusions reported; it appears the analysis was ITT. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: placebo‐controlled; no additional information provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to judge. |
Other bias | Low risk | Comment: no other sources of bias identified. |