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. Author manuscript; available in PMC: 2014 Sep 16.
Published in final edited form as: Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004228. doi: 10.1002/14651858.CD004228.pub2
Methods Cluster randomized trial (12 clinics randomized to 2 conditions)
Participants 345 women consuming alcohol during pregnancy. 245 women were followed to third trimester
Inclusion criteria: Pregnant women attending a special supplemental nutrition program for women, infants and children were screened and those described as “current drinkers” (any alcohol since pregnancy recognition) were included
Exclusion criteria: 24 women were referred to alcohol treatment programs, most exclusions were women who had not consumed alcohol since conception (3112) or had not consumed any alcohol since pregnancy recognition (603)
Women were recruited at an average of 18 weeks’ gestation.
Interventions Both groups had a comprehensive assessment of alcohol consumption at baseline
Experimental group: brief 10- to 15-minute intervention by a nutritionist using a script to encourage reduction in alcohol consumption. Reinforcement at each prenatal visit. Comparison group: women were assessed for alcohol use and advised to stop drinking during pregnancy
Outcomes Newborn outcomes including birthweight, length and condition at birth. Maternal abstinence from alcohol in pregnancy
Notes Analysis by logistic regression which took account of cluster randomization and other factors such as gestational age at booking. Results difficult to interpret
The study author kindly provided further unpublished data for inclusion in the review
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear Not described.
Allocation concealment? Unclear 12 clinics randomized to 2 conditions, it was not clear how randomization was achieved
Blinding?
Participants
No Educational intervention.
Blinding?
Care providers
No
Incomplete outcome data addressed?
All outcomes
No High risk of bias. Attrition 24.6% in the control group and 27.8% in the experimental group. Those lost to follow up were different in terms of race and education compared to those remaining part of the sample
Free of selective reporting? Unclear Pre-specified outcomes reported but results difficult to interpret