Methods |
Random allocation is presumed although method not described. |
Participants |
Dates of data collection: November 1971 and April 1972. |
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Setting: University of Pennsylvania. |
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Inclusion criteria: women undergoing primary CS or repeat section |
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Exclusion criteria: penicillin allergy, fever in labor. |
Interventions |
Ampicillin 1 g, methicillin 1 g and kanamycin 0.5 g IM 15-30 minutes before, and at 2 and 8 hours after delivery (N = 33) vs placebo (N = 28) |
Outcomes |
Endometritis (fever and uterine tenderness or fever and pathogenic organism without other cause); UTI; wound infection (fever, cellulitis and exudate); morbidity [fever > 100 °F in 2 separate 24 hour periods after first postpartum day or positive post-operative urine culture of > 100,000 colonies/ml] (treatment 9/33 vs placebo 17/28); UTI (fever and urinary tract symptoms or a single significant culture with or without fever); maternal hospital stay (6.5 vs 6.9 days; no variance given) |
Notes |
2 serious infections: 1 pelvic abscess in treatment group, 1 septicemia in placebo group. |
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Authors’ definitions of repeat and primary section not consistent with those used for elective/non-elective in this review |
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Class of antibiotic: aminopenicillin (ampicillin), penicillinase-resistant penicillin (me- thicillin), aminoglycoside |
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Subgroups:
type of CS unclear;
before cord clamping.
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Risk of bias |
Item |
Authors’ judgement |
Description |
Adequate sequence generation? |
Unclear |
“…the patient randomization.” |
|
|
Random allocation is presumed although method not described. |
Allocation concealment? |
Unclear |
Insufficient details provided. |
Blinding? |
Yes |
Placebo-controlled; study described as double-blind. |
All outcomes |
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“The materials were prepared by the pharmacy service in coded identical vials, containing identically appearing solutions.” No specific statement to confirm adequate blinding of study personnel |
Incomplete outcome data addressed? |
No |
No loss of participants to follow up. |
All outcomes |
|
17 patients “were eliminated from the study, 6 for errors in giving the study medications, 5 for penicillin allergies, 3 for fever in labor, 2 for being started on ampicillin prophylaxis, and 1 for cesarean hysterectomy” |
|
|
Analysis done on included patients; no data available to incorporate data on patients eliminated |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
“The patient randomization is statistically acceptable.” |
|
|
Insufficient other information to judge. |
Overall low risk of bias? |
No |
There is uncertainty around the sequence generation ad concealment allocation, and the high loss of data (17/61 = 28%) would suggest high risk of bias |