Sziller 1994.
Methods | RCT; 2 parallel groups. Unit of randomization: individual. |
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Participants | Dates of data collection: September 1990 to April 1991. Setting: Budapest, Hungary. Inclusion criteria: women who had opted for elective CS before onset of labor (definition not provided; indications included chronic fetal distress, breech position, placenta previa/placental abruption, prior uterine surgery; classified as elective for this review). Exclusion criteria: symptoms of infection prior to surgery; any illness that increased risk of infection (e.g. diabetes); penicillin allergy. |
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Interventions |
Intervention 1:
Intervention 2:
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Outcomes | Fever (categorized as mild [up to 37.5°C after the 1st 24 hrs lasting for at least 2 days (treatment n = 4 vs no treatment n = 5)]; moderate [> 38°C for at least 2 days (n = 0 vs n = 2)]; severe [> 38°C lasting > 3 days (n = 0 vs n = 2)];wound infection (induration of the abdominal incision, serosanguinous or purulent discharge, dehiscence of the wound); endometritis (fever plus lower abdominal pain, uterine tenderness, odorous discharge from the uterine cavity); UTI (pathogenic bacteria from mid‐stream urine); additional antibiotic treatment (treatment group n = 6 vs no treatment n = 13). | |
Notes | Translated from Hungarian. Class of antibiotic: beta‐lactam/beta‐lactamase inhibitor combination. Subgroups:
No significant differences between groups for age, indications for CS, gestational age, birthweight and previous CS. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Random table". |
Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no loss to follow‐up reported; no explanation for difference in numbers between groups (60 vs 44). |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information provided 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. |