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. 2012 Oct 17;2012(10):CD001321. doi: 10.1002/14651858.CD001321.pub5

Wing 2008.

Methods
  • Study design: 3‐arm RCT

  • Power calculation: no, feasibility pilot

  • Intention‐to‐treat analysis: yes

Participants Inclusion criteria
  • Setting: 2 centres

  • Country: USA

  • Women < 16 weeks gestation presenting for prenatal care at 1 of 2 centres

  • Number: 188 randomised and analysed


Exclusion criteria
  • Underlying medical conditions (e.g. diabetes mellitus, kidney failure, sickle cell disease, chronic hypertension, chronic kidney disease) previous or current antimicrobial therapy; known urological abnormalities

Interventions Treatment group 1
  • Cranberry juice: 240 mL at breakfast, placebo juice at other meals


Treatment group 2
  • Cranberry drink: 240 mL, 3 times/d, reducing to twice/d after 52 enrolments because not well tolerated


Control group
  • Placebo: 3 daily doses of matched juice product

Outcomes
  • Primary outcome: asymptomatic bacteriuria, > 108 cfu of a single organism and no symptoms

  • Secondary outcomes

    • Symptomatic bacteriuria, > 108 cfu of single organism and dysuria or frequency or urgency

    • Pyelonephritis, culture as above, + flak pain, fever > 100.4°F, chills nausea, vomiting

    • At least 1 UTI, UTI due to enteric bacteria,

    • Pregnancy outcomes: preterm delivery, spontaneous vaginal delivery, instrumental vaginal delivery, caesarean/caesarean hysterectomy, mean birth weight, low birth weight, 1 min Apgar < 7, 5 min Apgar < 9, admission to NICU, tolerability and compliance

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated randomisation table, stratified by site
Allocation concealment (selection bias) Low risk Treatment options were not known to researchers
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk States all were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Clearly stated
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Data are well reported for completeness
Losses to follow‐up/withdrawals: 73 withdrawals
Selective reporting (reporting bias) Low risk Appropriate outcomes
Other bias Low risk Details suggest free of bias, although selection methods a little unclear
Source of funding: NS

cfu ‐ colony forming units; CSU ‐ catheter specimen of urine; GFR ‐ glomerular filtration rate; ITT ‐ intention‐to‐treat; MSU ‐ midstream urine; NS ‐ not stated; PAC ‐ proanthocyanidin; SMP ‐ sulfamethoxazole; TMP ‐ trimethoprim; WBC ‐ white blood cell