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Moderate Prenatal Alcohol Exposure and Quantification of Social Behavior in Adult Rats
Published on: December 14, 2014
Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial.
Graeme B Wilson1, Ruth McGovern, Grace Antony
1Institute of Health & Society, Baddiley-Clark Building, Newcastle University, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.
Trials
|September 26, 2012
Summary
This pilot study assesses the feasibility of recruiting and retaining pregnant women in a randomized controlled trial for reducing risky drinking. Findings will inform a definitive trial on screening and brief intervention effectiveness in UK antenatal care.
Area of Science:
- Obstetrics and Gynaecology
- Public Health
- Addiction Medicine
Background:
- Risky drinking during pregnancy poses risks to fetal development.
- Brief interventions show promise in US antenatal care for reducing alcohol consumption.
- UK-specific evidence is needed to confirm the applicability of US findings.
Purpose of the Study:
- To determine the feasibility of recruiting and retaining pregnant women in a randomized controlled trial (RCT) for reducing risky drinking.
- To evaluate the effectiveness of screening and brief intervention in a UK antenatal care setting.
- To inform the design and power calculations for a definitive RCT.
Main Methods:
- Pilot RCT involving 31 community midwife sites in North-East England.
- Screening of 2,742 pregnant women using the Alcohol Use Disorders Identification Test (AUDIT-C).
- Randomized allocation of midwives to usual care or brief intervention (motivational interviewing).
Main Results:
- Primary outcomes focus on eligibility, recruitment, intervention delivery, and retention rates.
- Secondary data collection includes questionnaires on alcohol consumption, quality of life (EuroQoL EQ-5D-3 L), and healthcare resource utilization.
- Health economics component to assess cost-effectiveness and data collection for a main trial.
Conclusions:
- The study will yield a comprehensive trial protocol with precise sample-size calculations.
- Evidence on the effectiveness of screening and brief intervention for risky drinking in pregnancy will be extended.
- Participant feedback will confirm the acceptability of study instruments and procedures.

