Duff 1982.
Methods | Randomized placebo‐controlled trial; 2 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: January 1970 to June 1980. Setting: Washington, DC. US. Inclusion criteria: women undergoing CS who were not in labor and did not have ruptured membranes (elective). N = 82. |
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Interventions |
Intervention:
Comparison: placebo:
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Outcomes | Febrile morbidity (> 100.4 oF twice 6 hrs apart after the 1st 24 hrs); endomyometritis (fever, uterine and adnexal tenderness, purulent lochia); UTI; wound infection (induration, erythema and warmth with purulent drainage); need for antibiotics (treatment 1/42 vs placebo 6/40); maternal hospital stay (4.3 vs 4.6; no variance given). | |
Notes | No life‐threatening infection related complications nor bacteremic episodes in either group. Class of antibiotic: aminopenicillin (ampicillin). Subgroups:
The 2 groups were comparable regarding age, race, gravidity, parity and socioeconomic status. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: randomized; no description of sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information was provided. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no loss to follow‐up; no participant excluded; ITT analysis. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind" .... "placebo solution". |
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. |