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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; 2 parallel groups.
Unit of randomization: individual.

Participants Dates of data collection: February to July 1991.
Setting: Sousse Hospital, Tunisia.
Inclusion criteria: women undergoing elective CS or labor < 12 hours (categorized as ”both“ for this review”
Exclusion criteria: diagnosed amniotic infection; pyrexia >38°C; antibiotics within 3 days; allergy to beta lactam antibiotics; cardiac disease; diabetes

Interventions Cephapirine 1 g IV with induction of anesthesia and 6 hours after operation, gentamycin 80 mg IM with induction, metronidazole 500 mg IV with induction (N = 133), vs no treatment (N = 136)

Outcomes Endometritis; wound infection; pyrexia only (> 38°C 48 hours after surgery): antibiotic 4/133 vs control 9/136; septicemia (0/133 vs 3/136, included as serious morbidity); duration of hospital stay (antibiotic 5.36 days vs control 6.21, P = 0.03, variance not given)

Notes Follow up at 30 days (86%).
Translated from French.
Class of antibiotic: first generation cephalosporin, aminoglycoside and nitroimidazole (metronidazole)
Subgroups:
  • both elective and non-elective CS - not able to separate the data by type of CS;

  • before cord clamping.


Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Unclear Allocation “by chance”.

Allocation concealment? Unclear Using random number table, patients allocated to treatment if the number is even, no treatment if the number is odd

Blinding? No Not placebo controlled.
All outcomes

Incomplete outcome data addressed? Unclear No losses or exclusions reported. It appears to be ITT analysis
All outcomes

Free of selective reporting? Unclear Insufficient information to judge.

Free of other bias? Unclear The groups were similar for age, parity, duration of labor and other risk factors. There was insufficient other information to judge

Overall low risk of bias? Unclear Overall unclear.
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