Smoking, Nicotine and Pregnancy 2 Trial
Research type
Research Study
Full title
Impact of the ‘Baby, Me & NRT’ intervention on pregnant women’s adherence to nicotine replacement therapy (NRT): a randomised controlled trial
IRAS ID
287771
Contact name
Tim Coleman
Contact email
Sponsor organisation
University of Nottingham
ISRCTN Number
ISRCTN16830506
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Nicotine replacement therapy (NRT) helps non pregnant smokers to stop smoking. However, during pregnancy adherence is often low, for example the duration women take it and/or the amount taken is often not enough. Poor adherence reduces pregnant women’s chances of stopping smoking.
The aim of this study is to test whether a nicotine adherence intervention (NAI) affects pregnant women’s adherence to Nicotine Replacement Therapy (NRT) in the first 28 days of a quit attempt. The NAI runs alongside usual NHS stop smoking support, and involves providing women with a leaflet, website, SMS (text messaging) support and counselling support to encourage users to take NRT for longer and in more adequate doses.
We will recruit 264 pregnant smokers from antenatal care, smoking cessation clinics or online through various social media platforms such as Facebook/google. Participants will then be randomly divided into two groups. One group will receive usual NHS stop smoking support (NRT and behavioural support). The second group will receive the NAI, alongside usual NHS stop smoking support. We will determine whether the ‘Baby, Me & NRT’ NAI intervention added to usual NHS cessation support increases pregnant women’s duration of NRT use in the first 28 days following a quit date. Participants will provide saliva samples and possibly breath tests before and during the study to measure nicotine and carbon monoxide levels respectively. We will also ask about beliefs towards NRT before and during the study. We will follow women up at 36 weeks gestation and ask about their smoking and NRT use, a saliva sample and possibly a breathtest will be requested from women who report not smoking. Birth outcomes will be collected from hospital records.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
21/LO/0123
Date of REC Opinion
10 Feb 2021
REC opinion
Favourable Opinion