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

Bibi 1994.

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 hrs (categorized as "both" for this review"). N = 269.
Exclusion criteria: diagnosed amniotic infection; pyrexia ≥ 38oC; cases of failed vaginal instrumental deliveries; antibiotics within 3 days; allergy to beta lactam antibiotics; cardiac disease; diabetes.
Interventions Intervention:
  • cephapirine 1 g IV with induction of anesthesia and 6 hrs after operation, gentamycin 80 mg IM with induction, metronidazole 500 mg IV with induction;

  • N = 133.


Comparison: no treatment:
  • no treatment;

  • N = 136.

Outcomes Endometritis; wound infection; pyrexia only (≥ 38oC 48 hrs 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); cost of antibiotics given for treatment (440FF for treatment group vs 4294FF for control group).
Notes Translated from French.
Class of antibiotic: aminoglycoside‐containing combination (1st 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.


Follow‐up at 30 days (86%).
The groups were similar for age, parity, duration of labor and other risk factors.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "by chance".
Comment: no description of sequence generation process.
Allocation concealment (selection bias) High risk Comment: using random number table, patients allocated to treatment if the number is even, no treatment if the number is odd.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: no losses or exclusions reported; it appears to be ITT analysis.
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.