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: January 1975-January 1977.
Setting: Los Angeles County-University of Southern California Medical Center, Los Angeles, California, US, 87% Hispanic or Black
Inclusion criteria: women in labor with ruptured membranes who underwent internal fetal monitoring (classified as non-elective)
Exclusion: fever, other antibiotic use, penicillin allergy.
Interventions Cefazolin 1 g IV after the cord was clamped and at 4-6 hours and 10-12 hours postoperatively (N = 48) vs placebo (N = 45)
Outcomes Standard temperature morbidity, endomyometritis, abdominal wound infection, urinary infections (no definitions provided for any outcomes)
Notes 2 women were said to develop a serious infection: 1 (cefazolin group) developed septic thrombophlebitis and is included as a serious outcome; the other (placebo group) was treated with antibiotics for prolonged fever (judged not to be a serious outcome for this review)
Class of antibiotic: first generation cephalosporin.
Subgroups:
  • non-elective CS;

  • after cord clamping.

Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear “Randomized to numbered packages.” No further information.
Allocation concealment? Yes “… the agents having been randomized to numbered packages by the pharmacy department.”
Blinding? Yes Double blind study, placebo controlled; similar quantity of placebo given
All outcomes
The physician caring for the patient did not know which agent his patient received
Incomplete outcome data addressed? Unclear No loss to follow up reported.
All outcomes 7 women initially randomized not included in final analysis because they did not meet all the criteria (allocated group unknown) ITT analysis not performed.
Free of selective reporting? Unclear Insufficient information to judge.
Free of other bias? Unclear The 2 patient groups reported as similar. Insufficient information overall
Overall low risk of bias? Unclear Mostly unclear.
HHS Vulnerability Disclosure