Methods |
RCT; 2 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: not reported. |
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Setting: University College Hospital, Ibadan, Nigeria. Majority of patients from low socioeconomic class |
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Inclusion criteria: both elective and non-elective cesarean deliveries |
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Exclusion criteria: fever or obvious infection before operation |
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Interventions |
Ampicillin 500 mg before operation and 250 mg 6 hourly for at least 7 days (IM until able to take orally) (N = 58) vs no antibiotics unless temperature 38 degrees C after the third post-operative day (N = 48). Both groups received curative doses of chloroquine |
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Outcomes |
Wound infection; UTI (not defined further); ’genital sepsis’ (not defined further: study group 5/58; control group 15/48) |
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Notes |
Prophylaxis continued for 7 days. |
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Class of antibiotic: Aminopenicillin (ampicillin). |
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Subgroups |
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Risk of bias |
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Item |
Authors’ judgement |
Description |
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Adequate sequence generation? |
Unclear |
‘Divided randomly into 2 groups.’ |
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No additional details. |
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Allocation concealment? |
Unclear |
No information was provided. |
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Blinding? |
Unclear |
Not placebo-controlled. |
All outcomes |
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No additional details. |
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Incomplete outcome data addressed? |
Unclear |
No loss to follow up reported. |
All outcomes |
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No participants excluded; imbalance in group size not accounted for (58 vs 48) |
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ITT analysis. |
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
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Free of other bias? |
Unclear |
The 2 groups were comparable regarding age, parity and indications for CS |
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Overall low risk of bias? |
Unclear |
Very little information provided to assess risk of bias. |