CompletedInterventional

Smoking, nicotine and pregnancy 2 trial

Stopping smoking during pregnancy can be very difficult. Nicotine replacement therapy (NRT), like patches or gum, can help manage cravings, but many pregnant women find it tough to use NRT for long enough or in large enough doses to work well. Researchers have designed a support programme called 'Baby, Me & NRT'. It offers helpful text reminders, a website, and leaflets to encourage women to use NRT properly and ease their worries. In this trial, pregnant smokers will either receive standard NHS stop smoking support alone, or standard NHS support alongside the 'Baby, Me & NRT' package. Researchers will see whether the extra support helps women stay smoke-free, track their NRT use, and check birth records after delivery. Taking part involves using smartphone apps, giving saliva samples, and doing quick breath tests.

At a glance

Status

Completed

Sponsor

University of Nottingham

Enrolment target

1,320

Start

21 Jun 2021

Estimated completion

30 Jun 2026

Adherence to nicotine replacement therapy during pregnancy

What is this study about?

Smoking during pregnancy carries serious health risks for both mother and baby. Quitting is one of the best things a mother can do, but stopping completely can be extremely challenging. Nicotine replacement therapy (NRT) — which includes products like patches, gum, and mouth sprays — is a proven way to tackle cravings. However, evidence shows that many pregnant women stop using NRT too early or do not take a high enough dose to keep their cravings away.

To address this, researchers developed the 'Baby, Me & NRT' programme. This service provides regular, friendly text messages sent directly to your phone, along with a helpful booklet and website. The messages are designed to reassure women about using NRT safely in pregnancy, remind them to take their doses on time, and offer tips to handle difficult withdrawal symptoms.

The SNAP 2 trial aims to test whether adding 'Baby, Me & NRT' to regular NHS stop smoking care helps more pregnant women stay smoke-free. By comparing women who receive this digital support with women who receive usual NHS care, the researchers hope to discover the best ways to support future mothers and give babies the healthiest possible start.

Key takeaways

Tests a new digital support programme ('Baby, Me & NRT') alongside usual NHS stop smoking care.
Open to daily smokers who are 16 or older and under 25 weeks pregnant.
Aims to help pregnant women use nicotine replacement therapy (NRT) safely and effectively.
All participants receive standard NHS stop smoking advice and access to NRT.
Involves smartphone check-ins, quick breath tests, saliva samples, and follow-up until birth.

Who may be eligible?

You may be able to take part if you are at least 16 years old, less than 25 weeks pregnant, and currently smoke at least one cigarette every day. You must have smoked five or more cigarettes a day before becoming pregnant, be booked in for regular NHS antenatal care, and feel ready to set a quit date within the next two weeks.

Because the study uses mobile tools, you will need a smartphone that can receive text messages and download two study apps to record your progress. You will also need to be able to read and speak English and be happy to give your informed consent to take part.

You cannot join this study if you are already getting help from an NHS stop smoking service, another quit-smoking text service, or another clinical trial. You also cannot join if you already use NRT, or if you use e-cigarettes or heated tobacco and do not want to stop using them.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am 16 years of age or older.
I am currently pregnant and under 25 weeks along.
I currently smoke at least 1 cigarette every day.
I am ready and motivated to set a quit date within the next 14 days.
I own a smartphone that can receive texts and download apps.
I am not already using NRT, vapes, or enrolled in another stop smoking service.

Answer every question to see your result.

What does participation involve?

If you decide to join, a computer will place you at random into one of two groups. Everyone in the study will receive standard NHS stop smoking support, which includes free NRT products and expert behavioural advice. If you are placed in the second group, you will also receive the 'Baby, Me & NRT' package, which includes tailored text messages, an information booklet, and website access.

You will be asked to download two free apps onto your smartphone. One app helps you log your daily smoking and NRT use, while the other connects to a simple handheld breath monitor that checks your carbon monoxide levels. You will also provide small saliva samples to check nicotine levels and answer short surveys about your thoughts on NRT.

The researchers will follow up with you 28 days after your quit date and again when you are around 36 weeks pregnant. Finally, the team will check standard hospital records after your baby is born to see how your delivery went. The study lasts for the remainder of your pregnancy.

Potential risks and benefits

Taking part means you will receive high-quality NHS support to help you quit smoking, which can significantly benefit your health and your baby's development. You will also be helping to improve healthcare for other pregnant women in the future. There are no direct medical risks from taking part, though completing questionnaires, blowing into a breath monitor, and logging your symptoms will take a little time. Some women may also find thinking about the risks of smoking slightly upsetting. Your participation is completely voluntary, and you can withdraw at any point without it affecting your regular NHS maternity care in any way.

Locations (23)

Southport and Formby District General Hospital
Approximate
Southport, England
Kings Mill Hospital
Approximate
Sutton-in-Ashfield, England
Queen's Medical Centre
Approximate
Nottingham, England
Royal Derby & Burton Hospital
City only
Derby, England
Birmingham Women's Hospital
Approximate
Birmingham, England
Royal Preston Hospital
Unverified
Preston, England
Sunderland Royal Hospital
Unverified
Sunderland, England
Leighton Hospital
Unverified
Crewe, England
Nottingham City Hospital
Unverified
Nottingham, England
University Hospitals Birmingham NHS Foundation Trust
Unverified
Birmingham, England
Northern Lincolnshire and Goole NHS Foundation Trust
Unverified
Grimsby, England
Surrey and Sussex Healthcare NHS Trust
Unverified
Redhill, England

Common questions

Will I still get normal NHS stop smoking help if I join?

Yes. Every participant in the trial receives full, standard NHS stop smoking support, including behavioural advice and access to NRT.

Is nicotine replacement therapy safe during pregnancy?

Yes. Licensed NRT products contain only nicotine, making them far safer for you and your baby than smoking tobacco, which contains thousands of harmful chemicals and toxic gases.

Do I have to pay for the study apps or text messages?

No. The apps and text support are completely free to use throughout the study.

What happens if I slip up and smoke a cigarette during the trial?

You will not be asked to leave the study. Quitting smoking is a journey, and honest information helps researchers understand how real people cope when trying to stop.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time. You do not have to give a reason, and your decision will never affect the healthcare you receive from your midwife or doctor.

How to find out more

Lucy Phillips

snap2@nottingham.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.