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

Shah 1998.

Methods RCT; 4 parallel groups.
Unit of randomization: individual.
Participants Dates of data collection: not reported.
Setting: United Arab Emirates.
Inclusion criteria: women undergoing elective CS (definition not provided). N = 198.
Exclusion: hypersensitivity to penicillin or cephalosporin; prior antibiotic therapy within 3 days; hepatorenal insufficiency; positive cultures or definite evidence of infection.
Interventions Intervention: penicillin (A3):
  • pipericillin 4 g IV after the cord was clamped;

  • N = 48.


Intervention: penicillin (A3):
  • piperacillin 2 g IV after clamping of the cord and 2 g every 8 hrs x 2;

  • N = 52.


Intervention: drug combination [cephalosporin (B1) plus nitroimidazole (I)]:
  • cephradine 500 mg plus metronidazole 500 mg both IV after the cord was clamped and every 8 hrs x 2;

  • N = 47.


Comparison: no treatment:
  • no treatment;

  • N = 51.


Results of the 2 penicillin treatment groups were combined for this review.
Placebo data were divided: 2/3 for comparison with penicillin (A) and 1/3 for comparisons with the cephalosporin.
Outcomes Febrile morbidity (fever > 38oC twice 4 hrs apart after 1st day); endometritis (uterine and parametrial tenderness, foul smelling vaginal discharge); wound infection (local induration and tenderness with wound exudate).
Notes 3 women who developed drug reactions were excluded from study (1 from each of the treatment groups). Late morbidity evaluated at 4‐6 weeks.
Class of antibiotic: extended spectrum penicillin (ureidopenicillin (pipericillin)) vs other combination (1st generation cephalosporin plus nitroimidazole (metronidazole).
Subgroups:
  • elective CS;

  • after cord clamping.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "...randomized..".
Comment: no description of sequence generation process.
Allocation concealment (selection bias) Low risk Quote: "...consecutively numbered sealed envelopes..".
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: 14 women were excluded (8/147 from treatment groups, 6/51 from control group). As‐treated analysis with available outcome data.
Selective reporting (reporting bias) Unclear risk Comment: insufficient information to judge.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: no blinding, not placebo‐controlled
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Comment: probably outcome assessment was not blinded.
Other bias Low risk Comment: no other sources of bias identified.