Bibi 1994.
Methods | RCT; 2 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: February to July 1991. Setting: Sousse Hospital, Tunisia. Inclusion criteria: women undergoing elective CS or labor < 12 hrs (categorized as "both" for this review"). N = 269. Exclusion criteria: diagnosed amniotic infection; pyrexia ≥ 38oC; cases of failed vaginal instrumental deliveries; antibiotics within 3 days; allergy to beta lactam antibiotics; cardiac disease; diabetes. |
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Interventions |
Intervention:
Comparison: no treatment:
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Outcomes | Endometritis; wound infection; pyrexia only (≥ 38oC 48 hrs after surgery): antibiotic 4/133 vs control 9/136; septicemia (0/133 vs 3/136, included as serious morbidity); duration of hospital stay (antibiotic 5.36 days vs control 6.21, P = 0.03, variance not given); cost of antibiotics given for treatment (440FF for treatment group vs 4294FF for control group). | |
Notes | Translated from French. Class of antibiotic: aminoglycoside‐containing combination (1st generation cephalosporin, aminoglycoside and nitroimidazole (metronidazole). Subgroups:
Follow‐up at 30 days (86%). The groups were similar for age, parity, duration of labor and other risk factors. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "by chance". Comment: no description of sequence generation process. |
Allocation concealment (selection bias) | High risk | Comment: using random number table, patients allocated to treatment if the number is even, no treatment if the number is odd. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no losses or exclusions reported; it appears to be 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. |