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

Lookup NU author(s): Dr Graeme Wilson, Dr Ruth McGovern, Dr Grace Antony, Dr Mark Deverill, Erin Graybill, Dr Eilish Gilvarry, Professor Eileen Kaner, Dr Kirsty Laing, Professor Elaine McColl, Dr Dorothy Newbury-Birch, Professor Judith Rankin

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Abstract

Background: 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. Methods: 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. Discussion: The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention.


Publication metadata

Author(s): Wilson GB, McGovern R, Antony G, Cassidy P, Deverill M, Graybill E, Gilvarry E, Hodgson M, Kaner EFS, Laing K, McColl E, Newbury-Birch D, Rankin J

Publication type: Article

Journal: Trials

Year: 2012

Volume: 13

Issue: 1

Print publication date: 24/09/2012

ISSN (print): 0041-2538

ISSN (electronic): 1745-6215

Publisher: BioMed Central Ltd.

URL: http://dx.doi.org/10.1186/1745-6215-13-174

DOI: 10.1186/1745-6215-13-174

Notes: Article no. 174 is 9 pp.


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