Methods |
RCT, 3 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dates of collection: enrolment started November 1976. |
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Setting: San Bernadino county and University of California at Los Angeles Medical Centers; primarily indigent cases |
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Inclusion criteria: women undergoing CS. |
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Exclusion: emergency section, penicillin allergy, fever > 38 degrees C, on antibiotics; declined to participate |
Interventions |
Ampicillin 1 g IV 15-30 minutes before surgery and at 2 and 8 hours post-operatively (N = 38) vs ampicillin 1 g IV immediately after cord clamping and at 2 and 8 hours post-operatively (N = 40) vs no antibiotic (N = 36). Outcomes of both treatment groups combined |
Outcomes |
Endometritis; wound infection; UTI; maternal hospital stay (5.1 and 4.7 for pre- and post-administration of antibiotics respectively vs 6.0 for no treatment, variance not given) |
Notes |
Although emergency CSs were excluded, the women enrolled did not conform to our definition of an elective section. |
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Information on neonatal morbidity collected; there were 2 infants with definite infections in mothers who received no antibiotics and 1 infection in an infant where antibiotics were given after cord clamping |
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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 |
“at random.” |
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Method not described. |
Allocation concealment? |
Unclear |
No information. |
Blinding? |
No |
No blinding “…because of the different modes of administering the antibiotics, a double-blind study was not possible” Not placebo controlled. |
All outcomes |
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|
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“The investigator was not intimately involved with the post-operative care … and the pediatricians did not know into which group the mothers had been placed.” |
Incomplete outcome data addressed? |
Yes |
No loss of participants to follow up. |
All outcomes |
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No participant excluded after randomization. |
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ITT analysis. |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
Insufficient information to judge. |
Overall low risk of bias? |
Unclear |
Mostly unclear. |