Smoking, nicotine and pregnancy 2 trial

Not Applicable

• Conditions: Adherence to nicotine replacement therapy during pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN16830506
• Lead Sponsor: niversity of Nottingham

Brief Summary

2024 Protocol article in https://doi.org/10.1136/bmjopen-2024-087175 (added 29/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-16
• Last Update Posted: 10 June 2024
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 1320

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

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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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified