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. |
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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 |
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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 Results difficult to interpret The study author kindly provided further unpublished data for inclusion in the review |
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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 |