Methods |
RCT: 2 parallel groups. |
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Unit of randomization: individual. |
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Participants |
Dates of data collection: October 1977 to June 1980. |
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Setting: College Hospital, New Jersey, October. Women ‘predominantly black (90%) and socio-economically disadvantaged’ |
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Inclusion criteria: both elective and non-elective cesarean deliveries |
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Exclusion criteria: antibiotics within 2 weeks; pyrexia; any visible infection; penicillin allergy; known medical illness that might cause pyrexia; internal fetal scalp or uterine monitoring |
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Interventions |
Ticarcillin 6 g IV within 15 minutes of cord clamping (N = 139) vs saline placebo (N = 120). Subset of 22 in each group received ticarcillin 3 g/saline 6-8 hours post-operatively or saline placebo (results similar so authors combined results with single-dose group). |
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No post-operative antibiotics unless pyrexial > 38 degrees C after day 1 |
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Outcomes |
Endomyometritis (pyrexia, uterine tenderness and no evidence of other infection) |
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Notes |
Authors’ definition of low and high risk not comparable to definitions for elective/non-elective used in this review |
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Results for adolescent group (aged 15-18) reported in J Adolescent Health Care 1984;5: 163-166. In that study, incidence of endomyometritis in elective section: 0% for treatment vs 43% for placebo (numbers not given) |
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Class of antibiotic: aminopenicillin (ampicillin). |
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Subgroups: |
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type of CS unclear;
after cord clamping.
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Risk of bias |
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Item |
Authors’ judgement |
Description |
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Adequate sequence generation? |
Unclear |
‘Randomly divided into 2 groups.’ |
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Method not described. |
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Allocation concealment? |
Unclear |
No information. |
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Blinding? |
Unclear |
Placebo controlled (saline solution). |
All outcomes |
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Described as “double-blind”, but Insufficient information to judge if there was blinding of study personnel |
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Incomplete outcome data addressed? |
Unclear |
No loss of participants to follow up follow up and no participant excluded after analysis, however discrepancy in group numbers (139 vs 120) not accounted for ITT analysis. |
All outcomes |
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Free of selective reporting? |
Unclear |
Insufficient information to judge. |
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Free of other bias? |
Unclear |
“The prophylaxis and placebo groups were essentially similar in regard to important demographic and obstetric parameters. There were no significant differences between the groups for any of the variables studied”. There was insufficient other information which to judge |
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Overall low risk of bias? |
Unclear |
Placebo controlled. |