Brief alcohol intervention to reduce risky drinking in pregnancy: a pilot randomised controlled trial

Not Applicable

Completed

• Conditions: Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases; Mental and Behavioural Disorders

• Registration Number: ISRCTN43218782
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23006975

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-17
• Study Completion: 2012-08-31
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1. Women attending routine antenatal care
2. Women who book an antenatal appointment before 16 weeks gestation
3. Women who are aged 18 years or above
4. Women who provide verbal agreement to be screened for alcohol (written consent is not gathered for screening as this is usual practice in antenatal care)
5. Women who screen positive for risky alcohol use [score of 5+ on the Alcohol Use Disorders Identification Test(AUDIT-C)]
6. Women who give written consent to participate in the research; Target Gender: Female ; Lower Age Limit 18 years

Exclusion Criteria

1. Women with pregnancy complications (e.g. diabetes, congenital anomaly)
2. Women with multiple pregnancies
3. Women who book an antenatal appointment after 16 weeks gestation
4. Women with a history of substance use and/or alcohol dependence
5. Women who do not speak English sufficiently to participate
6. Women who are experiencing a severe mental or physical illness which is likely to impact upon the intervention or ability to be followed-up
7. Women who are already participating in other alcohol-related research
8. Women who lack the cognitive capacity to understand the research and what is involved (and are therefore unable to provide informed consent to participate)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participants recruited & retained; Timepoint(s): Baseline, 3rd trimester of pregnancy (6 months), 6 months post partum

Secondary Outcome Measures

Name	Time	Method
Alcohol consumption; Timepoint(s): In third trimester (6 months from baseline)