Smoking, nicotine and pregnancy 2 trial
| ISRCTN | ISRCTN16830506 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16830506 |
| IRAS number | 287771 |
| Secondary identifying numbers | CPMS 48261, IRAS 287771 |
- Submission date
- 15/03/2021
- Registration date
- 16/03/2021
- Last edited
- 26/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
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.
Who can participate?
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.
What does the study involve?
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.
What are the possible benefits and risks of participating?
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.
Where is the study run from?
University of Nottingham (UK)
When is the study starting and how long is it expected to run for?
November 2019 to January 2027
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Lucy Phillips, snap2@nottingham.ac.uk
Contact information
Mrs Lucy Phillips
Scientific
Scientific
University of Nottingham
Division of Primary Care
1406 Tower Building
Nottingham
NG7 2RD
United Kingdom
| snap2@nottingham.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | ISRCTN16830506_PIS_v1.1_22Feb2021.docx |
| Scientific title | Impact of the ‘Baby, Me & NRT’ intervention on pregnant women’s adherence to nicotine replacement therapy (NRT): a randomised controlled trial |
| Study acronym | SNAP2 |
| Study objectives | Current study hypothesis as of 25/01/2024: To investigate whether the ‘Baby, Me & NRT’ (BMN) intervention increases pregnant women’s rates of smoking cessation in late pregnancy. Previous study hypothesis: To determine whether the ‘Baby, Me & NRT’ intervention added to usual NHS cessation support increases pregnant women’s number of days of NRT use in the first 28 days following a quit date. |
| Ethics approval(s) | Approved 11/03/2021, London - Bloomsbury Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8196; bloomsbury.rec@hra.nhs.uk), ref: 21/LO/0123 |
| Health condition(s) or problem(s) studied | Adherence to nicotine replacement therapy during pregnancy |
| Intervention | We will recruit 1320 pregnant smokers who want to use NRT and receive stop smoking support. We will then randomize participants into two groups. The control group will receive standard NHS stop smoking support (usual care) and the intervention group will receive the ‘Baby, Me & NRT’ intervention alongside standard NHS stop smoking support. Usual Care and intervention description: Description of Usual Care - Usual care consists of standard NHS smoking cessation care in pregnancy, which includes: • Behavioural support to quit smoking • Nicotine Replacement Therapy (NRT); using NRT is established clinical practice and is recommended by NICE for pregnant women who cannot stop by other means. A 2015 survey found that 87% of English SSSs recommend ‘dual NRT’ to pregnant women who smoke • Setting a quit date within 14 days of a support session • Follow up support and a determination of whether cessation is achieved (usually a measure of carbon monoxide) • At the initial consultation women are given advice on how to use NRT to avoid withdrawal symptoms and cravings and are usually issued with up to 14 days’ NRT for use on and after the quit dates, further NRT will then be issued (if required) after the first 14 days. Description of the ‘Baby, Me & NRT’ Intervention (to be delivered alongside standard NHS smoking cessation care): i) At initial consultation • Amended behavioural support on how to use NRT, including using NRT throughout the whole of pregnancy, if needed, and not stopping NRT during brief lapses to smoking. • Counselling on using dual NRT during pregnancy that assesses and addresses women’s specific concerns about the safety of nicotine as determined from preparatory research. • Support on how to maintain adherence to NRT (e.g. use of problem-solving skills to overcome barriers to using NRT as advised or to manage a brief lapse to smoking). ii) Via leaflet, website or other media: • Reinforcement of key NRT adherence-enhancing messages potentially using mixed text and media iii) Up to 30 days of personally-tailored, automated text messages to: • Support participants to maintain abstinence • Encourage sufficient use of NRT for control of withdrawal symptoms or cravings • Counter deliberate non-adherence to NRT (e.g. due to concerns about nicotine) • Provide prompts or reminders and promote techniques to minimise forgetting to use NRT iv) Via video/telephone calls: • Assess participants’ experience of tobacco withdrawal symptoms and cravings and advise on amount of NRT used. Providing enhanced support on NRT use. The intervention will add no more than 30 minutes than usual care for the initial consultation, and the subsequent sessions will take no longer than 15 minutes each. Delivery regimen: Initial stop smoking practitioner (SSP) consultation: The SSP consultation will be delivered by a member of the research team who is also a fully trained Stop Smoking Practitioner working under an honorary contract. This consultation may occur in a variety of locations; by telephone/video call, in a private location in hospital or a community stop smoking service (SSS). All women will receive usual support, including provision of NRT. Women allocated to the NAI group will receive the behavioural support component of the NAI (see above, Description of the Intervention)alongside the following NAI components; leaflet, access to the intervention website, possibly a chatroom, and information about the intervention text-message support system, including how to stop messages. At the end of the consultation, using information provided by the participant about their previous use of NRT, views about NRT and date they plan to quit smoking (see 'data collection regimen' below), the personalised text-messaging system will be initiated by a researcher. NRT will be posted to women’s home after this appointment in preparation for their quit date. Women who are recruited face to face in a clinic may have their first saliva sample and possibly a CO reading taken after recruitment process while in clinic, whereas others, in particular those recruited online or those identified through PIC sites will be expected to complete the first sample (before quitting smoking) and possibly a CO reading themselves. A member of the research team will post women saliva sample kits and CO monitors (if required) for this, plus prepaid envelopes for postal return. Saliva samples are required at baseline and Day 7 from all women and a random sample of women will be expected to provide CO readings. A member of the research team will provide guidance on how to complete biological samples at baseline and Day 7, plus participants will also receive instruction forms. Day 2 prior to quit date to day 28 after quit date: Participants in the NAI group will receive daily text messages according to a predetermined schedule and also in response to interaction by the participant. Participants will be asked to respond by text message to occasional, pre-scheduled queries about smoking status and/or NRT use and these responses will be used for ongoing tailoring of their text messages. Participants can cancel the text message element of the support at any time by sending a ‘STOP’ text message. Days 3, 7, 14, 21, 28 after quit date: On or around days 3, 7, 14, 21 and 28 all participants will be contacted to receive further smoking cessation support. As necessary, arrangements will be made for participants to receive further NRT supplies. Telephone/video calls will be delivered by a member of the research team who is also a fully-trained stop smoking practitioner. If participants cannot be reached by telephone, we will send them a text message inviting a response and will try to telephone again after this. Participants in the NAI group will receive smoking cessation support with a greater focus on participants’ experience of using NRT and on providing specific advice to encourage adherence with NRT Data collection: Baseline: After obtaining consent but before delivery of study interventions and randomisation (participants will be randomised by the central research team), researchers (i.e. CRN working in trial centres or research team staff) will ask participants about gestation, nicotine dependence, current and pre-pregnancy smoking behaviours, prior experience using NRT, urges to smoke (cravings) and tobacco withdrawal symptoms. Participants will then be sent a link to survey to complete online about their NRT concerns and necessity beliefs, they will need to complete this survey before their first consultation with an SSP. Some of these items will be used to tailor/personalise text message support for women in the intervention group. Participants recruited through CRN researchers in the hospital will also asked to provide a saliva sample and may also be asked for an expired air CO reading after being consented into the study. CRN researchers will send the samples directly back to the laboratory. Saliva samples will measure cotinine and anabasine concentrations; these are both metabolites of nicotine and reflect nicotine exposure. However, anabasine is tobacco-specific and so differentiates nicotine exposure which is specifically due to smoking with that from other sources (e.g. NRT or e-cigarettes). Exhaled CO is an indicator of heaviness of smoking. For participants recruited via online or through PIC sites, the research team will send out saliva collection kits and CO monitors designed for individual use with instructions. All equipment used will be CE marked and used within its intended purpose. These women will be expected to return saliva samples by post directly to the laboratory before their quit date. Participants may be instructed to use a smartphone app in conjunction with the CO monitor, to send exhaled CO readings directly to the research team. Before quit date: a researcher will ensure all participants have provided a baseline sample and breath test (if required) and contact women with outstanding information. The researcher will also ensure women have received a saliva collection kit and CO monitor instructions so they can provide another sample/possible reading at Day 7. All participants will be asked to provide the contact details of their GP when joining the study. We will ask GP’s to contact us if they see any reason the participant should not take part in the study. Post randomisation, smoking cessation appointment- To inform a fidelity checklist for intervention delivery, We will audio record, with consent, all initial intervention group consultations and will then select a random sample of these for further scrutiny. Recording equipment will only be activated once consent has been given. Consent for this is optional. Day 7 after quit date: Participants are expected to provide a further expired air carbon monoxide reading (through the app, if possible) and saliva sample (using the postal kit sent to them). A member of the research team (most likely a SSP) will guide women to do this during their Day 7 SSP consultation. Also on Day 7 participants will be contacted by text message/email/telephone/post to complete survey questions about current smoking behaviours, use of NRT, urges to smoke (cravings) and tobacco withdrawal symptoms. If a postal saliva sample is not received and/or CO reading and/or survey questions are not completed, participants will receive a reminder text/emails and, if data is still not received, we will try to contact participants via telephone, and send the survey by post as a final method of obtaining survey data. We will aim to collect all data as close as possible to day 7 after quit date. Day 28 after quit date: participants will be contacted by text message/email/telephone/post to complete survey questions about current smoking behaviours, use of NRT, urges to smoke (cravings) and tobacco withdrawal symptoms. They will also be asked questions relating to their concerns and necessity beliefs about using NRT. Women in the intervention group will be asked about their engagement with the intervention components. Days 1 to 28 after quit date - All participants will be prompted regularly (maximum once daily) via an app they will install on their phone (called NicUse) which has been specifically designed for this study, and asked throughout the 4 weeks following their quit date to provide information on their daily use of: i) long-acting and short-acting NRT ii) e-cigarettes iii) smoking Participants who fail to supply adherence data via the NicUse app for 2 consecutive days will be sent an automated text reminder prompting them to restart this, followed by a further text reminder the following day if still not completed. Week 36 of pregnancy: on or around week 36 weeks of pregnancy (delivery if earlier) we will ask women (via text/email, telephone, postal) their smoking status, use of e-cigarette and NRT and whether they have delivered their baby. Women who report that they do not smoke will be sent a saliva sample to complete, and if they are using ECs or NRT they may also be asked to provide a CO reading. We will ask for a saliva sample to be returned by post to the laboratory and a CO reading to be obtained via participants own personal CO monitor, in some cases, for example when women are not contactable, the CO readings may obtained by hospital records (where possible). If a saliva sample and /or survey is not received, participants will receive a reminders by text/email/telephone to return outstanding survey/samples. The survey will then be sent by post if other methods fail. We will aim to collect all survey data/saliva samples/CO readings as close as possible to week 36 after quit date. Post-delivery: members of the research team will liaise with CRN midwives/hospitals where women were booked to deliver their baby, in order to collect data on birth outcomes from hospital records. They will also collect smoking at delivery data from hospital records for women who do not respond to the 36 weeks follow up. Fidelity of the intervention: This will involve audio recording, with consent, all initial intervention group consultations and we will then select a random sample of these for further scrutiny against a fidelity checklist which has been developed in a previous workstream. We will also conduct qualitative interviews with SSP who are members of the research team work under an NHS honorary contract. The aim of these interviews if to understand the barriers against and facilitators towards practitioners being able to deliver the intervention counselling combined with usual care support. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 25/01/2024: Smoking cessation in late pregnancy or around childbirth by participant self-report, with appropriate biochemical validation in late pregnancy from either saliva cotinine concentration below ≤10 ng/mL or exhaled CO reading ≤9 ppm. Previous primary outcome measure: Reported number of days NRT is used in the first 28 days after the quit date (daily questions through a mobile phone app for 28 days, survey at Day 7 and Day 28) |
| Secondary outcome measures | Current secondary outcome measures as of 25/01/2024: 1. Smoking cessation at both 28 days and in late pregnancy or at childbirth by participant self-report, with and without appropriate biochemical validation in late pregnancy from either saliva cotinine concentration below ≤10 ng/mL or exhaled CO reading ≤9 ppm 2. Smoking cessation for 24 hours or 7 days by participant self-report at 28 days 3. Adherence to NRT use measured as the number of days NRT is used in the first 28 days following a quit date from participants’ self-report 4. ’Intensity’ of NRT use measured as mean daily nicotine dose in the first 7 days following quit date from participants’ self-report 5. Engagement with BMN intervention measured in the first 28 days following a quit date by the participant reported engagement with components of the BMN intervention (daily tailored texts, leaflet and website) Pilot phase outcomes: 6. Urges to smoke ‘cravings’ and tobacco withdrawal symptoms on Day 7 and Day 28 from participant self-report 7. NRT concerns & necessity beliefs using the ‘NRT concerns & necessity beliefs’ survey at baseline and Day 28 completed by participants 8. Fidelity of intervention delivery at the Initial Pre-Quit consultation as measured against the fidelity checklist by the researcher 9. Cessation practitioners’ views on intervention delivery via semi-structured qualitative interviews at the end of delivery of the intervention Other outcomes: 10. Nicotine exposure measured by mean saliva cotinine concentrations and exhaled CO concentrations measured at baseline and Day 7 11. Adherence to NRT use measured by the number of days NRT use reported by participants between a quit date and the end of pregnancy 12. Adverse pregnancy outcome rates at the end of pregnancy measured by birth weight 13. Adverse pregnancy outcome rates at the end of pregnancy measured by low birth weight (<2500 g) 14. Adverse pregnancy outcome rates at the end of pregnancy measured by gestational age at birth 15. Adverse pregnancy outcome rates at the end of pregnancy measured by maternal or fetal death (stillbirth or miscarriage) 16. Adverse pregnancy outcome rates at the end of pregnancy measured by caesarean section delivery 17. Adverse pregnancy outcome rates at the end of pregnancy measured by neonatal intensive care admission 18. Adverse pregnancy outcome rates at the end of pregnancy measured by congenital anomaly 19. Cost-effectiveness of the BMN intervention measured by costs of usual care & intervention (e.g. cost of NRT, length and cost of consultations) at the end of pregnancy 20. Cost-effectiveness of the BMN intervention measured by costs of health care admissions for mother and infant at the end of pregnancy Previous secondary outcome measures: 1. Reported mean daily nicotine dose in the first 7 days following quit date (‘intensity’ of NRT use) (daily questions through a mobile phone app for 28 days, survey at Day 7) 2. NRT concerns & necessity beliefs (survey at baseline and Day 28) 3. Mean saliva cotinine concentrations (baseline, Day 7 and possibly at Week 36 gestation in women who report they have quit smoking) Other outcomes: 4. Number of days NRT use between a quit date and the end of pregnancy (Survey Day 7, Day 28 and Week 36 plus study app daily for first 28 days of intervention) 5. Self-reported smoking status in late pregnancy or at childbirth with (Week 36 survey) 6. Biochemical validation of reported cessation (Week 36 saliva sample) 7. Urges to smoke ‘cravings’ and tobacco withdrawal symptoms (survey at baseline, Day 7 and Day 28) 8. Exhaled carbon monoxide (CO) concentrations (Baseline breath test, Day 7 breath test and possible at Week 36 gestation in women who report they have quit smoking) 9. Birth weight (hospital records) 10. Low birth weight (<2500g) (hospital records) 11. Gestational age at birth (hospital records) 12. Maternal or fetal death (stillbirth or miscarriage). (hospital records) 13. Caesarean section delivery (hospital records) 14. Neonatal intensive care admission (hospital records) 15. Congenital anomaly (hospital records) 16. Fidelity of intervention delivery as measured against fidelity checklist (recordings of first consultation between Stop Smoking Practitioner (SSP) and participant) 17. Cessation practitioners’ views on intervention delivery (qualitative interviews with SSP after delivering study intervention) 18. Engagement with intervention components (Survey at Week 36 gestation) 19. Costs of usual care & intervention (e.g. cost of NRT, length and cost of consultations) (economic evaluation by study economist at end of study) 20. Costs of health care admissions for mother and infant (economic evaluation by study economist at end of study) |
| Overall study start date | 04/11/2019 |
| Completion date | 31/01/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 1320; UK Sample Size: 1320 |
| Key inclusion criteria | 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 give informed consent _____ Previous inclusion criteria: 1. Pregnant (<25 weeks’ gestation) 2. Aged 16 years or over 3. Having had first antenatal contact with a health professional (e.g. ‘booking’ appointment at ~ 8 weeks) 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 give informed consent |
| Key exclusion criteria | 1. Already enrolled in a smoking cessation study or NHS stop smoking support 2. Already enrolled in another text service to assist smoking cessation 3. 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 smoking 5. 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 |
| Date of first enrolment | 21/06/2021 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Southport and Formby District General Hospital
Southport and Ormskirk Hospital NHS Trust
Town Lane
Southport
PR8 6PN
United Kingdom
Town Lane
Southport
PR8 6PN
United Kingdom
Kings Mill Hospital
Sherwood Forest Hospitals NHS Foundation Trust
Mansfield Road
Sutton-in-Ashfield
NG17 4JL
United Kingdom
Mansfield Road
Sutton-in-Ashfield
NG17 4JL
United Kingdom
Queen's Medical Centre
Nottingham University Hospitals NHS Trust
Derby Road
Nottingham
NG7 2UH
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Royal Derby & Burton Hospital
University Hospitals of Derby and Burton NHS Foundation Trust
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Birmingham Women's Hospital
Birmingham Women's and Children's NHS Foundation Trust
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
Royal Preston Hospital
Lancashire Teaching Hospitals NHS Foundation Trust
Sharoe Green Lane North
Fulwood
Preston
PR2 9HT
United Kingdom
Sharoe Green Lane North
Fulwood
Preston
PR2 9HT
United Kingdom
Sunderland Royal Hospital
South Tyneside and Sunderland NHS Foundation Trust
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Leighton Hospital
Mid Cheshire Hospitals NHS Foundation Trust
Leighton
Crewe
CW1 4QJ
United Kingdom
Leighton
Crewe
CW1 4QJ
United Kingdom
Nottingham City Hospital
Nottingham University Hospitals NHS Trust
Nottingham
NG5 1PB
United Kingdom
Nottingham
NG5 1PB
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Northern Lincolnshire and Goole NHS Foundation Trust
Diana Princess of Wales Hospital
Scartho Road
Grimsby
DN33 2BA
United Kingdom
Scartho Road
Grimsby
DN33 2BA
United Kingdom
Surrey and Sussex Healthcare NHS Trust
Trust Headquarters
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
West Suffolk NHS Foundation Trust
West Suffolk Hospital
Hardwick Lane
Bury St. Edmunds
IP33 2QZ
United Kingdom
Hardwick Lane
Bury St. Edmunds
IP33 2QZ
United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Bedfordshire Hospitals NHS Foundation Trust
Lewsey Road
Luton
LU4 0DZ
United Kingdom
Luton
LU4 0DZ
United Kingdom
Doncaster Royal Infirmary
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
Doncaster
DN2 5LT
United Kingdom
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
London
NW3 2QG
United Kingdom
The Hillingdon Hospitals NHS Foundation Trust
Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom
Uxbridge
UB8 3NN
United Kingdom
University Hospital of Hartlepool
Holdforth Road
Hartlepool
TS24 9AH
United Kingdom
Hartlepool
TS24 9AH
United Kingdom
Wasall Manor Hospital
Moat Road
Walsall
WS2 9PS
United Kingdom
Walsall
WS2 9PS
United Kingdom
Dewi Sant Hospital
Albert Road
Pontypridd
CF37 1LB
United Kingdom
Pontypridd
CF37 1LB
United Kingdom
St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom
Carshalton
SM5 1AA
United Kingdom
Sponsor information
University of Nottingham
University/education
University/education
Research and Innovation, East Atrium, Jubilee Conference centre
Triumph Road
Nottingham
NG8 1DH
England
United Kingdom
| Phone | +44 (0)11584667906 |
|---|---|
| sponsor@nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0615-20003
No information available
National Institute for Health Research (NIHR) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The SNAP 2 dataset will be available upon request but set processes will need to be completed prior to data being shared via a secure drop off service, for example a possible data sharing agreement and CI sign off. snap2@nottingham.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1.1 | 22/02/2021 | 16/03/2021 | No | Yes |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 28/05/2024 | 29/05/2024 | Yes | No |
Additional files
- ISRCTN16830506_PIS_v1.1_22Feb2021.docx
- uploaded 16/03/2021
Editorial Notes
26/06/2025: The following changes were made:
1. Doncaster Royal Infirmary, Royal Free Hospital, The Hillingdon Hospitals NHS Foundation Trust, University Hospital of Hartlepool, Wasall Manor Hospital, Dewi Sant Hospital, and St Helier Hospital were added as study participating centres.
2. The United Kingdom - Wales was added as a country of recruitment.
3. The study contact was updated.
29/05/2024: Publication reference added.
25/01/2024: The following changes were made to the trial record:
1. The study hypothesis, primary and secondary outcome measures and study website were updated.
2. Bedfordshire Hospitals NHS Foundation Trust was added as a study participating centre.
3. The intention to publish date was changed from 01/01/2024 to 01/01/2027.
03/11/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2024 to 31/12/2025.
2. The overall end date was changed from 28/04/2025 to 31/01/2027.
3. The plain English summary was updated to reflect these changes.
4. The study participating centres Bradford Royal Infirmary, Chesterfield Royal Hospital were removed and University Hospitals Birmingham NHS Foundation Trust, Northern Lincolnshire and Goole NHS Foundation Trust, Surrey and Sussex Healthcare NHS Trust, University Hospitals Sussex NHS Foundation Trust, West Suffolk NHS Foundation Trust, Norfolk and Norwich University Hospitals NHS Foundation Trust were added.
5. The target number of participants was changed from 264 to 1320.
17/10/2022: The participant level data sharing plan was added.
29/09/2022: The recruitment end date was changed from 28/06/2023 to 30/06/2024.
21/06/2022: The following changes have been made:
1. The recruitment end date has been changed from 28/06/2022 to 28/06/2023.
2. The overall trial end date has been changed from 28/01/2023 to 28/04/2025 and the plain English summary has been updated to reflect this change.
21/01/2022: The recruitment end date was changed from 28/01/2022 to 28/06/2022.
12/01/2022: The inclusion criteria were changed.
10/09/2021: The public title was changed from "Smoking, nicotine replacement therapy and pregnancy trial 2" to "Smoking, nicotine and pregnancy 2 trial".
15/06/2021: The recruitment start date was changed from 01/06/2021 to 21/06/2021.
11/05/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 03/05/2021 to 01/06/2021.
2. The trial participating centres Nottingham City Hospital and Chesterfield Royal Hospital were added.
16/03/2021: The participant information sheet was uploaded as an additional file.
15/03/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
