Methods |
RCT; 3 parallel groups. |
|
Unit of randomization: individual. |
Participants |
Dates of data collection: February to June 1982. |
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Setting: Kaiser-Permanente Medical Center-Santa Clara, California |
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Inclusion criteria: all women undergoing CS (39/128 repeat section) |
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Exclusion: fever or infection, allergy to antibiotics. |
Interventions |
Cefoxitin 2 g in 1 L saline irrigation (N = 41) vs cephapirin 2 g in 1 L saline irrigation (N = 44) vs identical appearing placebo saline irrigation (N = 43) after delivery of the placenta; both treatment groups combined in the analysis |
Outcomes |
UTI (positive culture); wound infection (purulent wound discharge with or without wound separation); endometritis (fever > 100.4°F after first post-operative day, uterine tenderness, foul smelling lochia without other source) |
Notes |
Follow up for 8 weeks. |
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1 patient in placebo group developed septic pelvic thrombophlebitis and septic pulmonary emboli, classified as a serious complication |
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Class of antibiotic: first generation cephalosporin or second generation cephalosporin (cefamycin) |
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Subgroups:
type of CS unclear;
after cord clamping.
|
Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Yes |
“Sequenced randomly by lottery method.” |
Allocation concealment? |
Yes |
“1 milliliter of multivitamin infusion was added to create an identical appearance of all solutions .… and bags sequenced randomly … used in numerical order.” |
Blinding? |
Yes |
“Patients, physicians, operative room personnel and data collectors were… blinded to the group assignment.” |
All outcomes |
|
Incomplete outcome data addressed? |
Yes |
No loss to follow up reported. |
All outcomes |
|
4 patients were eliminated from the statistical analysis because ofdeviations from the protocol of irrigation technique Not ITT analysis. Data could not be re-included in the analysis |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
There were no statistically significant differences in mean gestational age, mean number of vaginal examination or mean duration of ruptured membranes between groups. There was insufficient other information which to judge |
Overall low risk of bias? |
Yes |
There is low risk of bias for the 4 major components. |