Adherence to nicotine replacement therapy during pregnancy Pregnancy and Childbirth
Conditions
Interventions
We will recruit 1320 pregnant smokers who want to use NRT and receive stop smoking support. We will then randomize participants into two groups. The control group will receive standard NHS stop smokin
using NRT is established clinical practice and is recommended by NICE for pregnant women who cannot stop by other means. A 2015 survey found that 87% of English SSSs recommend ‘dual NRT’ to pregnant w
Sponsors
University of Nottingham
Eligibility
Sex/Gender
Female
Age
16 Years to 100 Years
Inclusion criteria
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 _____ 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 25/01/2024: Smoking cessation in late pregnancy or around childbirth by participant self-report, with appropriate biochemical validation in late pregnancy from either saliva cotinine concentration below =10 ng/mL or exhaled CO reading =9 ppm. Previous primary outcome measure: Reported number of days NRT is used in the first 28 days after the quit date (daily questions through a mobile phone app for 28 days, survey at Day 7 and Day 28) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 25/01/2024: 1. Smoking cessation at both 28 days and in late pregnancy or at childbirth by participant self-report, with and without appropriate biochemical validation in late pregnancy from either saliva cotinine concentration below =10 ng/mL or exhaled CO reading =9 ppm 2. Smoking cessation for 24 hours or 7 days by participant self-report at 28 days 3. Adherence to NRT use measured as the number of days NRT is used in the first 28 days following a quit date from participants’ self-report 4. ’Intensity’ of NRT use measured as mean daily nicotine dose in the first 7 days following quit date from participants’ self-report 5. Engagement with BMN intervention measured in the first 28 days following a quit date by the participant reported engagement with components of the BMN intervention (daily tailored texts, leaflet and website) Pilot phase outcomes: 6. Urges to smoke ‘cravings’ and tobacco withdrawal symptoms on Day 7 and Day 28 from participant self-report 7. NRT concerns & necessity beliefs using the ‘NRT concerns & necessity beliefs’ survey at baseline and Day 28 completed by participants 8. Fidelity of intervention delivery at the Initial Pre-Quit consultation as measured against the fidelity checklist by the researcher 9. Cessation practitioners’ views on intervention delivery via semi-structured qualitative interviews at the end of delivery of the intervention Other outcomes: 10. Nicotine exposure measured by mean saliva cotinine concentrations and exhaled CO concentrations measured at baseline and Day 7 11. Adherence to NRT use measured by the number of days NRT use reported by participants between a quit date and the end of pregnancy 12. Adverse pregnancy outcome rates at the end of pregnancy measured by birth weight 13. Adverse pregnancy outcome rates at the end of pregnancy measured by low birth weight (<2500 g) 14. Adverse pregnancy outcome rates at the end of pregnancy measured by gestational age at birth 15 | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed