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Contact Information:

Dr Katharine Bowker
-
snap2@nottingham.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Smoking, nicotine and pregnancy 2 trial

Smoking, nicotine and pregnancy 2 trial

Medical Conditions

Adherence to nicotine replacement therapy during pregnancy


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.
We have created an intervention called ‘Baby, Me & NRT’ (BMN) to help improve adherence to NRT during pregnancy which emphasises the use of NRT for longer and in more adequate doses. BMN will run alongside usual NHS smoking cessation care. The intervention includes reinforcement of key NRT adherence-enhancing messages via a leaflet and a website. It also includes personally tailored SMS text messages which support abstinence, encourage NRT use to control withdrawal symptoms and/or cravings, counters concern about nicotine and so intentional non-adherence and minimise forgetting NRT through prompts and reminders.
The aim of this study is to test whether the BMN intervention improves pregnant women’s adherence to NRT and quit rates during pregnancy.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

21 Jun 2021 31 Dec 2025

Publications

2024 Protocol article in https://doi.org/10.1136/bmjopen-2024-087175 (added 29/05/2024)

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 compare the number of days NRT is used in the first 28 days following a quit date between the two groups. We will also compare the intensity of NRT use, days used NRT until the end of pregnancy, smoking status at the end of pregnancy and birth outcomes. 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 breath test will be requested from women who report not smoking. Birth outcomes will be collected from hospital records.


We will recruit pregnant smokers aged 16 years or older, from antenatal care, smoking cessation clinics or online through various social media platforms such as Facebook/Google.

You can take part if:


Current inclusion criteria as of 12/01/2022:

1. Pregnant (<25 weeks’ gestation)
2. Aged 16 years or over
3. Having been referred for or having received any kind of appointment as part of standard available antenatal care
4. Smoked 5 or more cigarettes per day pre-pregnancy and currently smoking at least 1 cigarette daily
5. Motivated to quit smoking, wants to try NRT and willing to set a quit date within 14 days
6. Agrees to accept the intervention or control, and to participate in study data collection
7. Owns a smartphone, uses it for sending and receiving SMS text messages, and agrees to install both the trial’s ‘NicUse’ app (collects data on smoking and NRT use) and an app for transferring exhaled carbon monoxide (CO) readings to study team
8. Understands written and spoken English
9. Able to


You may not be able to take part if:


1. Already enrolled in a smoking cessation study or NHS stop smoking support2. Already enrolled in another text service to assist smoking cessation3. Using an e-cigarette/vaping device and/or a heat not burn product, and not willing to stop using this to join the study 4. Already using NRT to quit or cut down smoking5. Contraindications to NRT including: severe cardiovascular disease, unstable angina, cardiac arrhythmias, recent cerebrovascular accident or TIA, chronic, generalized skin disorders or sensitivity to nicotine patches, chemical dependence / alcohol addiction; major fetal anomalies


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University Hospitals Birmingham NHS Foundation Trust
    Queen Elizabeth Hospital Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
    Colney Lane Colney
    Norwich
    NR4 7UY
  • University Hospitals Sussex NHS Foundation Trust
    Worthing Hospital Lyndhurst Road
    Worthing
    BN11 2DH
  • Bedfordshire Hospitals NHS Foundation Trust
    Lewsey Road
    Luton
    LU4 0DZ
  • Queen's Medical Centre
    Nottingham University Hospitals NHS Trust Derby Road
    Nottingham
    NG7 2UH
  • Nottingham City Hospital
    Nottingham University Hospitals NHS Trust
    Nottingham
    NG5 1PB
  • Surrey and Sussex Healthcare NHS Trust
    Trust Headquarters East Surrey Hospital Canada Avenue
    Redhill
    RH1 5RH
  • Sunderland Royal Hospital
    South Tyneside and Sunderland NHS Foundation Trust Kayll Road
    Sunderland
    SR4 7TP
  • West Suffolk NHS Foundation Trust
    West Suffolk Hospital Hardwick Lane
    Bury St. Edmunds
    IP33 2QZ
  • Royal Preston Hospital
    Lancashire Teaching Hospitals NHS Foundation Trust Sharoe Green Lane North Fulwood
    Preston
    PR2 9HT
  • Leighton Hospital
    Mid Cheshire Hospitals Nhs Foundation Trust Leighton
    Crewe
    CW1 4QJ
  • Northern Lincolnshire and Goole NHS Foundation Trust
    Diana Princess of Wales Hospital Scartho Road
    Grimsby
    DN33 2BA
  • Southport and Formby District General Hospital
    Southport and Ormskirk Hospital Nhs Trust Town Lane
    Southport
    PR8 6PN
  • Kings Mill Hospital
    Sherwood Forest Hospitals NHS Foundation Trust Mansfield Road
    Sutton-in-Ashfield
    NG17 4JL
  • Royal Derby & Burton Hospital
    University Hospitals of Derby and Burton NHS Foundation Trust Uttoxeter Road
    Derby
    DE22 3NE
  • Birmingham Women's Hospital
    Birmingham Women's and Children's NHS Foundation Trust Steelhouse Lane
    Birmingham
    B4 6NH

We cannot promise the study will help participants, but all participants will receive support to stop smoking based on the best NHS standards of practice. The information they provide to us during the study will be invaluable in helping us devise ways of supporting women who want to stop smoking during their pregnancy. We do not foresee there being any risks from taking part in this study. However, we appreciate that taking part will take time and may therefore be inconvenient. Also, some participants may be upset about receiving some basic information about the risks of smoking in pregnancy.

Dr Katharine Bowker
-
snap2@nottingham.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Nottingham and funded by NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0615-20003; National Institute for Health Research (NIHR) (UK).




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Read full details for Trial ID: ISRCTN16830506

Or CPMS 48261

Last updated 29 May 2024

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