Skip to main content
. 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 Randomized, placebo-controlled trial; 2 parallel groups.
Unit of randomization: individual.

Participants Dates of data collection: July 1986-December 1987.
Setting: Grenoble, France.
Inclusion criteria: ‘low-risk’ women, undergoing CS (27% in labor)
Exclusion: allergy to beta-lactam antibiotics, receipt of antibiotics within 3 days; ruptured membranes >12 hours; fever, amniotic infection

Interventions Cefotetan 1 g IV at the time of cord clamping (N = 136) vs placebo injection (N = 130)

Outcomes Endometritis, wound infection (includes superficial wound infection and deep abscess), septicaemia; additional antibiotic use (10/136 in treatment group vs 19/130 in placebo) ; antibiotic costs; maternal hospital stay

Notes There was 1 episode of septicaemia in the placebo group.
Class of antibiotic: second generation cephalosporin (cefamycin)
Subgroups:
  • type of CS unclear;

  • after cord clamping.


Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Unclear “…randomized by drawing of lots.”

Allocation concealment? Unclear No information provided.

Blinding? Yes Double blind, placebo-controlled.
All outcomes

Incomplete outcome data addressed? Yes No losses or exclusions were reported. Analysis appears to be ITT
All outcomes

Free of selective reporting? Unclear Insufficient information to judge.

Free of other bias? Unclear The 2 groups reported as comparable regarding demographic values. Insufficient additional information

Overall low risk of bias? Unclear Mostly unclear.
HHS Vulnerability Disclosure