Jaffe 1985.
Methods | Randomized placebo‐controlled trial: 2 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: not stated. Setting: Kfar‐Sava, Israel. Inclusion criteria: women undergoing CS. N = 78. Exclusion: women with active infection, allergy to penicillin and antibiotic treatment within 2 weeks. |
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Interventions |
Intervention:
Comparison: placebo:
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Outcomes | Febrile morbidity (> 38oC twice at least 4 hrs apart after 1st 24 hrs post‐operative); endometritis (fever and uterine tenderness); UTI (single culture of > 100,000 bacteria/mL); wound infection (redness, cellulitis, tenderness and exudate from incision). | |
Notes | Authors' definition of emergency not consistent with definitions used in this review (classified as 'both/undefined'). Class of antibiotic: extended spectrum penicillin (ureidopenicillin (mezlocillin)). Subgroups:
The 2 groups were comparable regarding age, parity, rupture of membranes, duration of ruptured membranes, number of vaginal examinations, duration of anesthesia, and indications for CS. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "...randomly assigned..". Comment: no description of sequence generation process. |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: it is unclear whether all patients randomized were included in the analysis but no losses or exclusions were reported. It appeared to be an ITT analysis. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to judge. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "Placebo‐controlled". Comment: insufficient information to judge. |
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. |