Rehu 1980.
Methods | RCT; 3 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: September 1977‐January 1978. Setting: State Maternity Hospital, Helsinki, Finland. Inclusion criteria: all women undergoing CS. N = 128. Exclusion criteria: allergic to penicillin, clindamycin or gentamicin; emergency section. |
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Interventions |
Intervention: penicillin:
Intervention: combination (lincosamides plus aminoglycoside):
Comparison: placebo:
Placebo data spilt for comparison with the 2 antibiotic groups. |
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Outcomes | Endometritis (fever, uterine tenderness and foul‐smelling vaginal discharge); wound infection (all grades combined); hospital stay (treatment 7.7 vs 7.7 placebo; no variance given). | |
Notes | Data from a 4th group that consisted of patients allergic to 1 of the drugs or undergoing an emergency section have not been included. Drug class: natural penicillin or aminoglycoside‐containing combination (lincosamide (clindamycin) and aminoglycoside). Subgroups:
The 1st 3 groups were comparable regarding number of amnioscopic examinations, number of vaginal examination, duration of labor and duration of intrauterine monitoring. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Assigned at random". Comment: no description of sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Quote: " ... in bottles containing code numbers". Comment: insufficient information to judge. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no loss to follow‐up reported; 2 women excluded after initial randomization. ITT analysis with available data. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the code was kept secret for persons performing the operations and observing the patients in the post‐operative period".. Comment: placebo‐controlled (glucose solution) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the code was kept secret for persons .... observing the patients in the post‐operative period". |
Other bias | Low risk | Comment: no other sources of bias identified. |