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. Author manuscript; available in PMC: 2014 May 2.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007482. doi: 10.1002/14651858.CD007482.pub2
Methods RCT; 3 parallel groups.
Unit of randomization: individual.

Participants Dates of data collection: initiated March 1981.
Setting: Charlottesville, Virginia, USA, almost all were indigent women
Inclusion criteria: both ‘low risk’ (labor < 6 hours) and ‘high risk’ (> 6 hours) women undergoing CS
Exclusion criteria: allergy to penicillin or cephalosporin; antibiotic use within 7 days; antibiotics required for other reasons; pyrexia >38° C; foul amniotic fluid.

Interventions Irrigation of the uterus and peritoneal cavity with 2 g cefamandole in 1000 ml normal saline (N = 73), vs saline placebo (N = 75) vs no irrigation group (N = 44). As the objective of this review is to compare antibiotic with no antibiotic, rather than the effect of irrigation, only the first 2 groups are compared (double blind comparison)

Outcomes Metritis (pyrexia >38°C twice 8 hours apart, after 24 hours plus abnormal uterine tenderness, without another apparent source); duration of maternal stay (treatment 5. 29 days vs placebo 6.32 days, variance could not be calculated)

Notes Authors’ definition of low and high risk do not correspond to those used for elective/ non-elective in this review.
No treated patients developed evidence of drug reaction.
There were no serious infections (pelvic abscess or phlebitis) in either group
Class of antibiotic: second generation cephalosporin.
Subgroup:
  • both elective and non elective;

  • after cord clamping.


Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Yes ’A computer generated table of random numbers.”

Allocation concealment? Yes ”Assigned under the direction of the hospital pharmacy.”

Blinding? Yes Partially double blind placebo-controlled (3 groups: antibiotic irrigation, saline placebo irrigation, no irrigation). Physicians were unaware ofthe type ofirrigation used
All outcomes

Incomplete outcome data addressed? Yes No loss to follow up reported.
All outcomes No participants excluded.
ITT analysis.

Free of selective reporting? Unclear Insufficient information to judge.

Free of other bias? Unclear The groups were comparable regarding gra-vidity, parity, maternal weight, hematocrit, etc. There was insufficient other information which to judge

Overall low risk of bias? Yes Good sequence generation, concealment allocation, blinding and complete outcome data
HHS Vulnerability Disclosure