Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Katarzyna Campbell
+44 (0) 115 74 84 508
kasia.campbell@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 3 Trial

Smoking, Nicotine and Pregnancy 3 Trial

Medical Conditions

Smoking in 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.


Nicotine replacement therapy (NRT) provides nicotine without the toxins contained in cigarette smoke. When used with specialist support, it helps pregnant women stop smoking. The NRT instruction booklet includes use for preloading, reduction and lapse recovery; studies suggest that allowing people to smoke and use NRT together helps with stopping. Currently, NHS stop smoking support advises pregnant women not to smoke when using NRT. This study will test whether relaxing this message could help pregnant women to quit and improve babies’ health. The aim of this study is to test support for the following three uses of NRT:
1. Preloading - using nicotine patches for a short time when still smoking but preparing to stop
2. NRT in ‘slip ups’ (smoking occasional cigarettes) – advice to keep on with NRT during short ‘slip ups’; this may help them stop smoking for good
3. For women who cannot quit, using NRT to smoke less – this could also help them stop smoking; if not, breathing in less harmful cigarette smoke should make babies healthier

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:

01 Apr 2022 31 Dec 2025

Participants will be randomly assigned into two groups. One group will receive usual NHS stop smoking support (counseling and NRT). The second group will also receive support with preloading NRT patches for up to 4 weeks before they try to quit and using NRT during ‘slip-ups’. Women who cannot stop after 6 weeks will receive support and an offer of NRT to help them to reduce their smoking. The researchers will collect saliva and breath samples before/during the study to measure nicotine and CO levels respectively. They will ask women about their smoking 6 weeks into the study and when they are 36 weeks pregnant. They will collect data on birth outcomes. Data will be compared between the two groups.


Pregnant women (pregnant for 25 weeks or less) who smoke

You can take part if:


Current inclusion criteria as of 08/03/2022:

Women of any age who:
1. Are <25 weeks’ gestation and have been referred for or have received or attended an intment as part of standard antenatal care
2. Smoke ≥ 5 daily cigarettes
3. Willing to set a quit date and accept referral to SSS
4. Willing to use NRT patch to try to stop smoking
5. Able to understand written and spoken English
6. Able


You may not be able to take part if:


Current exclusion criteria as of 21/11/2023:1. Already in a cessation study2. Contraindications to NRT including: known severe reaction/hypersensitivity to NRT, recent cardiovascular/cerebrovascular event or changes and taking theophylline/clozapine3. Currently uses e-cigarette every day or more frequently

Previous exclusion criteria:1. Already in a cessation study2. Currently uses e-cigarettes daily or more frequently 3. Contraindications to NRT including: severe cardiovascular disease, unstable angina, cardiac arrhythmias, recent cerebrovascular accident or transient ischaemic attack (TIA), chronic, generalized skin disorders or sensitivity to nicotine patches, chemical dependence/alcohol addiction or major fetal anomalies4. Not able to read or understand text written in English


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

  • Cardiff & Vale University LHB
    Woodland House Maes-Y-Coed Road
    Cardiff
    CF14 4HH
  • The Royal London Hospital
    80 Newark Street
    London
    E1 2ES
  • East Lancashire Hospitals NHS Trust
    Royal Blackburn Hospital Haslingden Road
    Blackburn
    BB2 3HH
  • Royal Berkshire Hospital
    London Road
    Reading
    RG1 5AN
  • Royal Free London NHS Foundation Trust
    Royal Free Hospital Pond Street
    London
    NW3 2QG
  • Royal Cornwall Hospitals NHS Trust
    Royal Cornwall Hospital Treliske
    Truro
    TR1 3LJ
  • Worcestershire Royal Hospital
    Charles Hastings Way
    Worcester
    WR5 1DD
  • Great Western Hospitals NHS Foundation Trust
    Great Western Hospital Marlborough Road
    Swindon
    SN3 6BB
  • Wirral University Teaching Hospital NHS Foundation Trust
    Arrowe Park Hospital Arrowe Park Road Upton
    Wirral
    CH49 5PE
  • Leighton Hospital
    Leighton
    Crewe
    CW1 4QJ
  • Milton Keynes University Hospital
    Standing Way Eaglestone
    Milton Keynes
    MK6 5LD
  • Stoke Mandeville Hospital
    Mandeville Road
    Aylesbury
    HP21 8AL
  • London North West University Healthcare NHS Trust
    Northwick Park Hospital Watford Road
    Harrow
    HA1 3UJ
  • North Cumbria Integrated Care NHS Foundation Trust
    Pillars Building Cumberland Infirmary Infirmary Street
    Carlisle
    CA2 7HY
  • Sherwood Forest Hospitals NHS Foundation Trust
    Kings Mill Hospital Mansfield Road
    Sutton-in-ashfield
    NG17 4JL
  • Powys Teaching Lhb
    Bronllys Hospital Bronllys
    Brecon
    LD3 0LS
  • Epsom and St Helier University Hospitals NHS Trust
    St Helier Hospital Wrythe Lane
    Carshalton
    SM5 1AA
  • The Hillingdon Hospitals NHS Foundation Trust
    Pield Heath Road
    Uxbridge
    UB8 3NN
  • University Hospitals Dorset NHS Foundation Trust
    Management Offices Poole Hospital Longfleet Road
    Poole
    BH15 2JB
  • Bolton NHS Foundation Trust
    The Royal Bolton Hospital Minerva Road Farnworth
    Bolton
    BL4 0JR
  • Sandwell and West Birmingham Hospitals NHS Trust
    City Hospital Dudley Road
    Birmingham
    B18 7QH
  • New Cross Hospital
    Wolverhampton Road Heath Town
    Wolverhampton
    WV10 0QP
  • Warrington Hospital
    Lovely Lane
    Warrington
    WA5 1QG
  • University Hospital of Hartlepool
    Holdforth Road
    Hartlepool
    TS24 9AH
  • University of Nottingham
    School of Medicine and Health Sciences University Park
    Nottingham
    NG7 2RD
  • Walsall Healthcare NHS Trust
    Manor Hospital Moat Road
    Walsall
    WS2 9PS
  • The Princess Alexandra Hospital
    Hamstel Road
    Harlow
    CM20 1QX
  • Buckinghamshire Healthcare NHS Trust
    Amersham Hospital Whielden Street
    Amersham
    HP7 0JD
  • County Durham and Darlington NHS Foundation Trust
    Darlington Memorial Hospital Hollyhurst Road
    Darlington
    DL3 6HX
  • Manchester University NHS Foundation Trust
    St Marys Hospital Oxford Road
    Manchester
    M13 9WL
  • Cwm Taf NHS Trust
    Dewi Sant Hospital Albert Road
    Pontypridd
    CF37 1LB
  • Swansea Lhb
    Kidwelly House, Charter Court Phoenix Way Swansea Enterprise Park
    Swansea
    SA7 9FS
  • Aneurin Bevan Lhb - Caerphilly Locality Office
    Llanarth House Newbridge Gateway Bridge Street
    Newport
    NP11 5GH
  • Birmingham Children's Hospital
    Steelhouse Lane
    Birmingham
    B4 6NH
  • Hull University Teaching Hospitals NHS Trust
    Bay 2 - Specialist Midwives Office Antenatal Day Unit Women’s & Children’s Hospital Anlaby Road
    Hull
    HU3 2JZ
  • York and Scarborough Teaching Hospitals
    Surgery and Family Health LARC York Hospital Wigginton Road
    York
    YO31 8HE

The researchers cannot promise that the study will directly benefit participants, but all participants will receive support to stop smoking based on the best NHS standards of practice. The information they provide during the study will be invaluable in helping the researchers design future ways of helping pregnant women stop smoking. The researchers do not foresee there being any risks from taking part in this study. However, taking part will take time and may therefore be inconvenient. Some participants may be upset when discussing the risks of smoking in pregnancy.

Dr Katarzyna Campbell
+44 (0) 115 74 84 508
kasia.campbell@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 Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR129210.




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Read full details for Trial ID: ISRCTN84798566

Or CPMS 49947

Last updated 14 November 2024

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