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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 RCT (individual randomization).
Participants Setting: women attending for prenatal care at a Boston, USA hospital. Women were screened at their first antenatal appointment
250 pregnant women meeting inclusion criteria randomized.
Inclusion criteria: women identified as being at risk for prenatal risk drinking. All had consumed some alcohol in the 6 months before recruitment and scored 2 or more on an alcohol screening tool T-ACE (none of the women had current diagnoses of alcohol or drug abuse dependence). More than half of the women included reported that they were abstaining from alcohol at the time of recruitment
Exclusion criteria: gestational age > 28 weeks, no alcohol consumed in the previous 6 months, miscarriage, planned to attend elsewhere for care, planned abortion, non-English speaking, participation in substance abuse programme
Baseline characteristics of experimental and comparison group participantswere reported as being similar. Mean gestation at recruitment = 16 weeks
Interventions Experimental group: comprehensive alcohol assessment and 45-minute educational counselling intervention including identifying the woman’s drinking goal, motivation, risk situation for drinking and alternatives to alcohol. Women were provided with a manual on how to prevent alcohol-related problems at end of counselling
Comparison group: comprehensive alcohol assessment but no active intervention Both groups received $50 for completing the assessment and $75 for the postpartum follow-up interview
Outcomes Antepartum alcohol consumption; reductions in and abstinence from alcohol; birth weights; Apgar scores at 1 and 5 minutes
Notes Authors contacted formore information on study design and results and kindly provided some additional information
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Computer-generated random assignment.
Allocation concealment? Unclear No information.
Blinding?
Participants
No Educational intervention by physician.
Blinding?
Care providers
No
Blinding?
Outcome assessors
Unclear Postpartum outcome assessor reported to be blind to results of initial assessment
Incomplete outcome data addressed?
All outcomes
Yes Few women lost to follow up. (Participants were paid to complete assessments.)
Free of selective reporting? Unclear Few direct comparisons between experimental and comparison groups
Free of other bias? Unclear Results difficult to interpret. Experimental and comparison groups were not compared for many outcomes