Helping pregnant smokers quit: a multi-centre study of electronic cigarettes and nicotine patches

Not Applicable

Completed

• Conditions: Smoking cessation; Mental and Behavioural Disorders; Mental and behavioural disorders due to use of tobacco

• Registration Number: ISRCTN62025374
• Lead Sponsor: Queen Mary University of London

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35577966/ (added 17/05/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37840301/ (added 16/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-21
• Study Completion: 2020-11-26
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1140

Inclusion Criteria

1. Daily smokers
2. 12 to 24 weeks pregnant
3. Wants help with stopping smoking
4. Willing to be randomised to use either NRT or EC (to avoid selective drop-out and contamination)
5. Wiling to receive 6 weekly support calls over the phone plus two follow-up calls
6. Speaks English (to allow data collection via phone)
7. Aged 18 years or over

Exclusion Criteria

1. Known allergic reaction to nicotine skin patches (a contraindication for patch use)
2. Current daily use of NRT or EC
3. Taking part in another interventional trial
4. Serious medical problem or high-risk pregnancy (to avoid problems with follow-up and data collection)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prolonged abstinence rates at the end of pregnancy, defined as per Russell Standard (up to 5 lapses allowed from 2 weeks after the target quit day until end of pregnancy, with no smoking at all during the previous week at the time of follow-up), and verified by salivary cotinine (< 15 ng/ml) for those not reporting using any nicotine product and anabasine (< 1 ng/ml) for those reporting other forms of nicotine use.

Secondary Outcome Measures

Name	Time	Method
1. Smoke intake and nicotine intake, measured by salivary anabasine and salivary cotinine levels, assessed for participants still using NRT or EC at end of pregnancy and for ‘dual users’<br>2. 7-day point-prevalence abstinence (not a puff in the last 7 days), self-reported at 4 weeks, end of pregnancy and at 3 months post-partum<br>3. Prolonged abstinence, self-reported at end of pregnancy and 3 months post-partum<br>4. Use of NRT and EC throughout pregnancy, measured by asking participants on how many days they used their products at each weekly contact and at follow-ups<br>5. Safety examined by looking at the proportion of participants reporting adverse events and serious adverse events in each group throughout pregnancy; proportion of participants in each group reporting adverse events and serious adverse events for themselves or their infant at 3 months post-partum; and differences in birth and maternal outcomes between the two groups