Ledger 1974.
Methods | Randomized trial Time period: 28 Oct 1971 through 28 July 1972 |
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Participants | Inclusion criteria: clinically "severe" obstetric/gynecologic infections that required parenteral antibiotics as deemed by attending or resident physician Site: University of Michigan Hospital, USA Number of participants: n = 44 |
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Interventions | Clindamycin varied dosage every 6‐8 hours with kanamycin 0.5 mg every 12 hours (n = 21) vs penicillin G 5‐10 million units every 6‐8 hours with kanamycin every 12 hours (n = 23) | |
Outcomes | Treatment failure, additional therapy required (antibiotic usage or surgical intervention), bacterial species identified | |
Notes | Pharamceutical sponsorship: Upjohn Did not provide data separately for those patients with endometritis |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized blocks of 10 envelopes |
Allocation concealment (selection bias) | Low risk | Sealed numbered envelopes utilized |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Initial selection was blinded, but both physician and patient were privy to the treatment at the time of administration |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding for outcomes noted |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No drop outs |
Selective reporting (reporting bias) | Low risk | It appears as though all outcomes were reported |
Other bias | Low risk | ‐ |