Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Graeme Wilson


Contact details

Institute of Health and Society
21-23 Claremont Place
Newcastle Upon Tyne
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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



Study hypothesis

RADiANT: Reducing Alcohol Drinking in ANTenatal women v1.0, this study will investigate whether it is possible to recruit and retain pregnant women in a pilot trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. The comparison condition will be the usual advice delivered by midwives. We will train midwives to assess pregnant women’s alcohol consumption and obtain consent from those drinking at risky levels to participate in the pilot trial. A trained alcohol counsellor will deliver the brief intervention which will help women understand the nature of alcohol-related risk to their baby and to themselves and identify simple ways of cutting down on their drinking. Subsequently, we will establish if pregnant women are willing to be followed up in the third trimester of pregnancy and six months after their baby is born. We will also measure women’s alcohol consumption, their quality of life and use of NHS services using validated questionnaires. From medical records we will, with participating women's consent, collect information relating to their social circumstances including their age and the number of children they have had. Lastly, we will also record the baby’s birth weight and the age at which the baby was born measured in terms of the number of weeks of pregnancy, and data on fetal loss and abnormality. The information we collect will be used to determine if it will be possible to conduct a full trial which will measure the impact of brief intervention at reducing risky drinking in pregnancy compared to standard advice delivered by midwives.

Ethics approval


Study design

Randomised; Interventional; Design type: Prevention, Screening

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet


Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases


Brief alcohol advice, Control condition - 5 minutes of simple structured alcohol advice delivered by midwife [Treatment As Usual (TAU)].

Brief alcohol intervention, Experimental condition - 5 minutes of simple structured alcohol advice delivered by midwife (TAU) plus a 20 minute client-centred intervention based on motivational interviewing delivered by alcohol counsellor within 2 weeks of initial appointment.

Intervention type



Not Applicable

Drug names

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)

Participant recruitment issue


Participant 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

Participant type


Age group




Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Participant 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)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Institute of Health and Society
Newcastle Upon Tyne
United Kingdom

Sponsor information


Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Midwifery Research Dept
Leazes Wing
Queen Victoria Road
Newcastle upon Tyne
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute of Health Research (NIHR) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2012 protocol in

Publication citations

  1. Protocol

    Wilson GB, McGovern R, Antony G, Cassidy P, Deverill M, Graybill E, Gilvarry E, Hodgson M, Kaner EF, Laing K, McColl E, Newbury-Birch D, Rankin J, Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial., Trials, 2012, 13, 174, doi: 10.1186/1745-6215-13-174.

Additional files

Editorial Notes

29/10/2018: The overall trial status has been changed to 'Stopped'. 26/10/2018: No publications found, verifying study status with principal investigator.