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

Stiver 1983.

Methods Randomized, placebo‐controlled trial; 3 parallel groups.
Unit of randomization: individual.
Participants Dates of data collectin: no reported.
Setting: 5 centers in Canada.
Inclusion criteria: all women in labor or with ruptured membranes (duration of ruptured membranes not stated; mean duration 9.97 hrs; included in both category). N = 361.
Interventions Intervention 1: 1st generation cephalosporin:
  • cefazolin 1 g;

  • N = 120.


Intervention 2: cefamycin:
  • cefoxitin 2 g;

  • N = 124.


Comparison: placebo:
  • placebo;

  • N = 117.


Infused IV immediately after cord clamped and 6 and 12 hrs later. Results of both treatment groups combined.
Outcomes Febrile morbidity (oral temperature > 37.9oC twice at least 6 hrs apart after 1st 24 hrs); wound infection (redness, induration, tenderness and/or purulent discharge from the incision line); endometritis/parametritis (uterine and/or adnexal tenderness with fever) UTI (dysuria or pyuria and positive culture); need for antibiotic therapy (11% for treatment groups vs 27% for placebo); maternal length of stay (7.3 and 7.4 days for treatment groups vs 7.9 for placebo).
Notes Side effects documented: 2 infusion‐related hypotensive episodes (1 with cefazolin, 1 with placebo that necessitated withdrawal from study); 6 episodes of phlebitis (5 in treated, 1 in placebo group); 1 episode of angioedema (placebo patient). Data provided on antibiotic resistance in wound isolates and screening cervical cultures. 1 episode of bacteremia (in placebo group); 1 episode of septic shock (in cefazolin‐treated group); both outcomes included as serious morbidity.
 Follow up at 6 weeks.
Class of antibiotic: 1st generation cephalosporin or cefamycin (2nd generation cephalosporin).
Subgroups:
  • both elective and non‐elective CS;

  • after cord clamping.


The 3 groups were comparable regarding age, parity, gravidity, etc.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomly assigned".
Comment: no description of sequence generation process.
Allocation concealment (selection bias) Unclear risk Comment: no information provided.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: 7 women (1 in treatment, 6 in placebo group) initially randomized but results not included, 6 because they failed to receive all 3 doses, 1 because of hypotensive episode with 1st dose. As‐treated analysis performed.
Selective reporting (reporting bias) Unclear risk Comment: insufficient information to judge.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Comment: double‐blind, placebo‐controlled.
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.