Morrison 1973.
Methods | Quasi‐RCT; 2 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: not reported. Setting: City of Memphis Hospitals, Tennessee; indigent women, many obstetric and metabolic complications. Inclusion criteria: all women undergoing CS. N = 330. Exclusion criteria: febrile or infected. |
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Interventions |
Intervention: drug combination [penicillin + aminoglycoside]:
Comparison: no treatment:
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Outcomes | Fever (> 100.9oF after 2nd post‐operative day), severe pelvic infection (treatment 27% vs control 7%); 'free of infectious morbidity' (3.6 vs 6.8 days); maternal hospital stay (5.4 vs 8.8 days, no variance given). | |
Notes | No adverse drug reactions reported; no evidence of development of resistance reported.
Unable to ascertain from description of study incidence of endometritis or wound infection; inadequate description of nature of severe pelvic infections (not included as outcome in analysis).
2 groups of women were studied retrospectively (N = 75); methods nor results do not specifically describe results of this group and it is unclear whether they have been included in the overall results. Class of antibiotic: aminoglycoside‐containing combination (natural penicillin and aminoglycoside. Subgroups:
The 2 groups were comparable regarding gravidity, parity, age and operative indicators. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "...every other patient". Comment: quasi‐RCT. Alternate allocation to treatment or no treatment. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no loss to follow‐up; no participants excluded. ITT analysis. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no blinding; not placebo‐controlled. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: probably outcome assessment was not blinded. |
Other bias | Low risk | Comment: no other sources of bias identified. |