Pregnancy Trial of E-cigarettes and Patches (PREP)
Research type
Research Study
Full title
Helping Pregnant smokers quit: A multi-centre RCT of electronic cigarettes and nicotine patches
IRAS ID
220190
Contact name
Mays Jawad
Contact email
Sponsor organisation
Queen Mary University of London, Joint Research Management Office
Eudract number
2017-001237-65
ISRCTN Number
ISRCTN62025374
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Research Summary
Smoking in pregnancy remains an unresolved issue. Quit rates in pregnant smokers are low and advice by doctors and nurses, even when combined with behavioural support and nicotine replacement treatment (NRT) has only limited efficacy.
Electronic cigarettes (EC) may overcome these limitations. EC allow flexible dosing and have a faster effect than NRT. They also provide some of the sensations and enjoyment that smokers get from smoking. These characteristics should ensure better treatment adherence.
It is estimated that in the UK half a million smokers switched from smoking to vaping (EC use) so far, with 20,000 quitting smoking with the help of EC per year who would not have quit otherwise. There is thus a strong rationale for testing the efficacy of EC as a stop-smoking treatment for pregnant women.
We propose to randomise 1,140 pregnant smokers to either behavioural support provided by pro-active phone calls and accompanied by nicotine patches, or to the same support accompanied instead by EC. The two study arms would be compared in validated abstinence rates at end of pregnancy and in a number of other outcomes including adverse effects and birth and maternal outcomes.
A positive result would provide a new, inexpensive, and practical tool to tackle an important and so far
unresolved problem.The study will recruit pregnant smokers from hospital sites across England and stop-smoking services in Scotland, and is funded by the NIHR.
Summary of Results
Like many other smokers in the UK, some pregnant smokers try to limit or stop their smoking with the help of e-cigarettes (EC). It is not known whether this helps with stopping smoking and whether using EC has any bad effects on the baby.
We recruited 1,140 pregnant smokers who wanted to quit. Half were randomly given nicotine patches, which are commonly used to help smokers quit. The other half were given an EC. They were also phoned once a week for four weeks to support them in stopping smoking. We then looked at how many in each group stopped smoking by the end of pregnancy.
More women were smoke-free in the group that was given an EC, but the difference was small and could be due to chance. However, some of the women in the nicotine patch arm stopped smoking with the help of EC. When these were not counted, EC helped almost twice as many women stop smoking than patches.
EC were better than patches in preventing low birth weight (having babies that weigh less than 2.5 kg). Otherwise, women given patches and those given EC (and their babies) had similar number of serious medical complications.
For pregnant women who smoke and need help to quit, EC are probably more helpful than nicotine patches, and do not pose any additional risks to women or their babies.REC name
London - South East Research Ethics Committee
REC reference
17/LO/0962
Date of REC Opinion
29 Jun 2017
REC opinion
Favourable Opinion