Methods |
Random allocation is presumed although method not described. |
Participants |
Dates of data collection: August 1972 to February 1973. |
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Setting: University of Pennsylvania. |
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Inclusion criteria: women undergoing CS. |
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Exclusion criteria: penicillin allergy, fever in labor. |
Interventions |
Ampicillin 1 g and kanamycin 0.5 g IM 15 to 30 minutes before, and at 2 and 8 hours after delivery (N = 34) vs placebo (N = 34) |
Outcomes |
Endometritis (fever and uterine tenderness or fever and pathogenic organism without other cause); UTI; wound infection (fever, cellulitis and exudate; any grade); morbidity [fever > 100°F in two separate 24 hour periods after first postpartum day or positive post-operative urine culture of > 100,000 colonies/ml] (treatment 8/34 vs placebo 22/34) |
Notes |
1 pelvic abscess in placebo group. |
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Authors’ definitions of repeat and primary section not comparable to those used for elective/non-elective in this review, categorized as ‘both’ |
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Class of antibiotic: aminopenicillin (ampicillin), 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 |
“Randomization of patients is acceptable.” |
|
|
Random allocation of patients is assumed but 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 |
“25 patients were eliminated because of penicillin allergy, fever in labor, errors in giving the medication, etc. None was used as a control.” |
All outcomes |
|
An ITT analysis was not performed and the data cannot be re-included |
Free of selective reporting? |
Unclear |
Insufficient information to judge. |
Free of other bias? |
Unclear |
“Randomization of patients is acceptable”. |
|
|
The groups were comparable regarding age, rupture of membranes, indication for CS and anemia |
|
|
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 (25/68 = 37%) would suggest high risk of bias |