Abstract
BackgroundRisky 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.MethodsThe 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.DiscussionThe study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention.Trial RegistrationCurrent Controlled Trials ISRCTN43218782
Highlights
Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies
Screening with brief interventions in healthcare settings is increasingly recognized as an effective approach to improving public health, and is prioritized in the UK government’s recent alcohol strategy [16]
Brief intervention against heavy drinking in pregnant women seeks to achieve change to a lower level of consumption than the universal guidelines to reduce short-term risk to the pregnancy; even a change during the limited period of pregnancy and early infancy can be considered a successful outcome in this respect
Summary
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. 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. This project focuses on the reduction of risky alcohol consumption during pregnancy. A large number of pregnancies, those in women from lower socio-economic positions, are likely to be significantly related to alcohol [6]
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