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

Sokolowski 1989.

Methods RCT; 2 parallel groups.
Unit of randomization: individual.
Participants Date of data collection: not stated.
Setting: Magdeburg, Germany.
Inclusion criteria: women undergoing CS (both elective and non‐elective).
Exclusion criteria: none reported.
Interventions Intervention 1:
  • metronidazole 1 g post‐operative days 1 and 2, then 500 mg from days 3 ‐ 8 (vaginal tablet);

  • N = 172.


Intervention 2:
  • no treatment;

  • N = 204.

Outcomes Fever (> 37.5°C for at least 3 days post‐operatively). Data also given for outcome of high fever (> 38.5°C) (7/172 vs 29/204 for treatment and control groups respectively); puerperal infection and wound infection were combined as "other diseases" (8/172 vs 11/204).
Notes Translated from German.
Class of antibiotic: nitroimidazoles.
Subgroups:
  • both elective and non‐elective CS;

  • after cord clamping.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: Described as "by random selection"; women with surnames A‐K received treatment, women with surnames L‐Z did not.
Comment: quasi‐RCT.
Allocation concealment (selection bias) Unclear risk Comment: no information provided.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no loss to follow‐up reported; no participant excluded.
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.