Methods |
Randomized placebo-controlled trial; 2 parallel groups. |
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Unit of randomization: individual. |
Participants |
Dates of data collection: January 1975-January 1977. |
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Setting: Los Angeles County-University of Southern California Medical Center, Los Angeles, California, US, 87% Hispanic or Black |
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Inclusion criteria: women in labor with ruptured membranes who underwent internal fetal monitoring (classified as non-elective) |
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Exclusion: fever, other antibiotic use, penicillin allergy. |
Interventions |
Cefazolin 1 g IV after the cord was clamped and at 4-6 hours and 10-12 hours postoperatively (N = 48) vs placebo (N = 45) |
Outcomes |
Standard temperature morbidity, endomyometritis, abdominal wound infection, urinary infections (no definitions provided for any outcomes) |
Notes |
2 women were said to develop a serious infection: 1 (cefazolin group) developed septic thrombophlebitis and is included as a serious outcome; the other (placebo group) was treated with antibiotics for prolonged fever (judged not to be a serious outcome for this review) |
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Class of antibiotic: first generation cephalosporin. |
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Subgroups:
non-elective CS;
after cord clamping.
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Unclear |
“Randomized to numbered packages.” No further information. |
Allocation concealment? |
Yes |
“… the agents having been randomized to numbered packages by the pharmacy department.” |
Blinding? |
Yes |
Double blind study, placebo controlled; similar quantity of placebo given |
All outcomes |
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|
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The physician caring for the patient did not know which agent his patient received |
Incomplete outcome data addressed? |
Unclear |
No loss to follow up reported. |
All outcomes |
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7 women initially randomized not included in final analysis because they did not meet all the criteria (allocated group unknown) ITT analysis not performed. |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
The 2 patient groups reported as similar. Insufficient information overall |
Overall low risk of bias? |
Unclear |
Mostly unclear. |