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. 2014 Nov 17;2014(11):CD008726. doi: 10.1002/14651858.CD008726.pub2

Spinnato 2000.

Methods RCT. Individual women. 3‐arm study.
Participants Inclusion criteria
  • Women requiring CS.

  • N = 301, data available on 298.


Exclusion criteria
  • Known hypersensitivity to any study antibiotic, preoperative diagnosis of chorioamnionitis, antibiotic therapy within the previous 24 hours, known HIV‐positive serology, and women who refused to participate in the study. During the study period, women known to be group B beta haemolytic streptococcus carriers were treated intrapartally with antibiotics and thus were excluded from the study.

Interventions Intervention: cephalosporin (B2).
  • Cefotetan.

  • 2 g; IV; immediately after the umbilical cord was clamped.

  • N = 96.


Comparison 1: penicillin (A4).
  • Ampicillin.

  • 2 g; IV; immediately after the umbilical cord was clamped.

  • N = 101.


Comparison 2: penicillin (A4) combination.
  • Ampicillin + sulbactam.

  • 3 g; IV; immediately after the umbilical cord was clamped.

  • N = 101.

Outcomes Endomyometritis; wound complications.
Notes Dates: 24 January 1994 to 12 December 1996.
Setting: University of Louisville Hospital, US.
Subgroups
  1. Mixed types of CS, both elective and non‐elective.

  2. After cord clamping.

  3. IV administration.

  4. Single doses.

  • Comparisons: 1 (subgroups 1 & 2); 2; 3; 4; 8.

  • Authors report "Owing to the absence of endometritis among patients undergoing elective, non‐labouring cesarean delivery (n = 92), the data were also analysed after excluding these patients." We have not reported on this subgroup of women as the randomisation appears not to have been stratified by type of CS.

  • We have pooled data from ampicillin and ampicillin/sulbactam. Authors report that "Ampicillin/sulbactam combines a B lactam antibiotic with a B lactamase inhibitor extending its antibacterial spectrum". This data will be considered for inclusion in the review 'Different regimens of penicillin antibiotic prophylaxis at caesarean section for reducing maternal morbidity'.

  • No information about funding source of study.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk “...patients were randomized...”.
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk “...double‐blinded...”.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Double‐blinded but unclear if the outcome assessors were blinded or not.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Three out of 301 women (1.0%) were not evaluated due to incomplete information data that restricted chart retrieval.
Selective reporting (reporting bias) Unclear risk The study protocol was unavailable.
Other bias Unclear risk Baseline characteristics were similar on: age; gestational age; height and weight. Other possible biases were unclear. No information about funding source of study.