Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care.</p> <p>Methods</p> <p>The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742) attending their booking appointment with a community midwife (n = 31) in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C). Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120). Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control) or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention). As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants’ views on instruments and procedures will be sought to confirm their acceptability.</p> <p>Discussion</p> <p>The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention.</p> <p>Trial Registration</p> <p>Current Controlled Trials ISRCTN43218782</p

Determinants of pregnant women's compliance with alcohol guidelines: a prospective cohort study

<p>Abstract</p> <p>Background</p> <p>In 2009, Australian alcohol guidelines for pregnancy changed from low to no alcohol intake. Previous research found a high proportion of pregnant Australian women drank during pregnancy; however, there has been limited investigation of whether pregnant women comply with 2009 alcohol guidelines. The purpose of this study was to provide an assessment of pregnant women’s compliance with 2009 Australian alcohol guidelines and identify predictors of such compliance, including previous drinking behaviour.</p> <p>Methods</p> <p>Cross-sectional analysis of prospective data from the 1973–1978 cohort of the Australian Longitudinal Study on Women’s Health was conducted. Women aged 30–36 years who were pregnant at the 2009 survey and had data on alcohol use were included (n = 837). Compliance with 2009 alcohol guidelines for pregnancy was defined as no alcohol intake. Predictors of compliance were analysed using multivariate logistic regression, controlling for area of residence, in three separate models to account for multicollinearity between measures of previous alcohol intake (compliance with 2001 guidelines; frequency and quantity; bingeing). Private health insurance, household income, and illicit drug use were entered into all models and retained if significant.</p> <p>Results</p> <p>72% of pregnant women did not comply with the 2009 alcohol guidelines and 82% of these women drank less than seven drinks per week, with no more than one or two drinks per drinking day. The odds of complying with abstinence increased by a factor of 3.48 (95% CI 2.39-5.05) for women who previously complied with the 2001 alcohol guidelines and decreased by a factor of 0.19 (95% CI 0.08-0.66) if household incomes were $36,400 or more. In other models the odds of complying were lower for women who consumed alcohol before pregnancy at least weekly (OR = 0.40, 95% CI 0.25-0.63) or binged (OR ≥ 0.18, 95% CI 0.10-0.31) and were higher for those who abstained (OR = 45.09; 95% CI 8.63-235.49) prior to pregnancy.</p> <p>Conclusion</p> <p>Most pregnant women did not comply with alcohol guidelines promoting abstinence. Prior alcohol behaviour was the strongest predictor of compliance during pregnancy, suggesting alcohol use should be addressed in women of child-bearing age. The study is limited by the relatively short timeframe between the official introduction of the 2009 guidelines and the date the surveys were sent out. Widespread dissemination of the guidelines may be necessary to help increase guideline compliance by pregnant women.</p