Methods |
RCT; 2 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dates of data collection: October 1976 and March 1977. |
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Setting: Walter Reed Army Medical Center, Washington DC. |
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Inclusion criteria: all women undergoing either primary or repeat CS (44% elective) |
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Exclusion criteria: penicillin allergy; chorioamnionitis prior to surgery |
Interventions |
Ampicillin 1 g IV prior to surgery and 6 and 12 hours post-operatively (N = 26) vs placebo (N = 31) |
Outcomes |
Febrile morbidity (> 100.3 °F twice 6 hours apart after first 24 hours); endomyometri-tis (fever, uterine and abdominal tenderness, purulent lochia); UTI (positive culture); wound infection (induration, erythema and warmth with purulent drainage); need for antibiotics (treatment 3/26 vs placebo 13/31); maternal hospital stay (6.03 vs 6.9; no variance given) |
Notes |
Class of antibiotic: aminopenicillin (ampicillin). |
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Subgroups:
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Unclear |
“In a … randomized manner.” |
|
|
Not further described, prepared by hospital pharmacy. |
Allocation concealment? |
Unclear |
Prepared by the hospital pharmacy. |
Blinding? |
Yes |
Double-blind, placebo controlled. |
All outcomes |
|
The pharmacist was the only individual with access to the treatment protocol |
Incomplete outcome data addressed? |
No |
No losses to follow up were reported. 23/80 excluded because of errors in dispensation of medication |
All outcomes |
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Analysis was not ITT; data from excluded patients could not be re-included |
Free of selective reporting? |
Unclear |
Insuffient information to judge. |
Free of other bias? |
Unclear |
“There is a notable difference in the division of repeat sections between groups”. |
|
|
There was insufficient other information which to judge |
Overall low risk of bias? |
No |
Unclear sequence generation and concealment allocation, along with high exclusions |