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. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3

Duff 1982.

Methods Randomized placebo‐controlled trial; 2 parallel groups.
Unit of randomization: individual.
Participants Dates of data collection: January 1970 to June 1980.
Setting: Washington, DC. US.
Inclusion criteria: women undergoing CS who were not in labor and did not have ruptured membranes (elective). N = 82.
Interventions Intervention:
  • ampicillin 1 g 30 min prior to surgery and at 4 and 8 hrs post‐operatively;

  • N = 42.


Comparison: placebo:
  • placebo solution;

  • N = 40.

Outcomes Febrile morbidity (> 100.4 oF twice 6 hrs apart after the 1st 24 hrs); endomyometritis (fever, uterine and adnexal tenderness, purulent lochia); UTI; wound infection (induration, erythema and warmth with purulent drainage); need for antibiotics (treatment 1/42 vs placebo 6/40); maternal hospital stay (4.3 vs 4.6; no variance given).
Notes No life‐threatening infection related complications nor bacteremic episodes in either group.
Class of antibiotic: aminopenicillin (ampicillin).
Subgroups:
  • elective CS;

  • before cord clamping.


The 2 groups were comparable regarding age, race, gravidity, parity and socioeconomic status.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: randomized; no description of sequence generation process.
Allocation concealment (selection bias) Unclear risk Comment: no information was provided.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no loss to follow‐up; no participant excluded; ITT analysis.
Selective reporting (reporting bias) Unclear risk Comment: insufficient information to judge.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "double‐blind" .... "placebo solution".
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: insufficient information to judge.
Other bias Low risk Comment: no other sources of bias identified.