Phelan 1979.
Methods | Randomized, placebo‐controlled trial; 2 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: July to December 1976. Setting: Naval Regional Medical Center, Portmouth, Virginia, US. Inclusion criteria: all women undergoing CS (46/122 were a repeat section). The authors' definition of primary and repeat do not correspond to definitions of elective and non‐elective used in this review (repeat sections included women in labor with ruptured membranes). The results for these 2 categories have been combined in this review. Exclusion criteria: allergy to penicillin or cephalosporin, infection or receiving antibiotics. |
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Interventions |
Intervention: 1st generation cephalosporin:
Comparison: placebo:
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Outcomes | Endometritis (fever and uterine tenderness or fever and pathogenic organism); UTI (fever and symptoms, or positive culture); wound infection (fever, cellulitis and exudate); maternal hospital stay (treatment 5.5 days vs placebo 5.7 days, no variance given). | |
Notes | 2 women developed serious complications as stated by the authors: 1 in treatment group developed septic pelvic thrombophlebitis; 1 given placebo developed pneumonia and endoparametritis (both included in outcome of serious morbidity). Class of antibiotic: 1st generation cephalosporin. Subgroups:
The 2 groups were comparable regarding age, height, weight, etc. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly". Comment: no description of sequence generation process. |
Allocation concealment (selection bias) | Low risk | Quote: "All preparations supplied had a code number known only by the pharmacy". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: 8 women excluded for mistakes in protocol (no further details) could not be included in ITT analysis. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "All materials appeared similar in solution". Comment: described as double‐blind, matching placebo. |
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. |