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

Helping pregnant smokers quit: a multi-centre RCT of electronic cigarette and nicotine patches

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN62025374

Enrollment

1142

Registered

2017-03-21

Start date

2018-01-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking cessation Mental and Behavioural Disorders Mental and behavioural disorders due to use of tobacco

Interventions

Randomisation will be conducted by a web-based application system created by the trialists' clinical trials unit. Randomisation will be in blocks of mixed sizes. Allocation is 1:1. Participants will

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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’ 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 3. Prolonged abstinence, self-reported at end of pregnancy and 3 months post-partum 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 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	—

Measure

Time frame

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’ 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 3. Prolonged abstinence, self-reported at end of pregnancy and 3 months post-partum 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 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

—

Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026