BREATHE: A Realist Evaluation study to understand smoking tobacco cessation and how to support pregnant women with this

Realist EvAluation to understand smoking Tobacco cessation and How to support pregnant womEn

Registry ID
ISRCTN18430450
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
King's College London
Enrollment
60
Start date
2026-03-01
Completion date
2027-07-30
Last update
2026-08-17

Conditions

Summary

Smoking tobacco cessation in pregnant women

Detailed description

The study will run for 22 months across three NHS Trusts in West Yorkshire. It involves two main components: Interviews with pregnant women who smoke or have recently quit, and with staff who deliver smoking cessation support. Analysis of routinely collected maternity and neonatal data from the participating Trusts (e.g. gestation at booking, smoking status, referral to services, birth outcomes). Participants and data collection: Pregnant women: Women aged 18 or over, receiving antenatal care, identified by their clinical team as smokers or recent quitters. Around 5-10 women from each site will be interviewed. Staff: Midwives, stop smoking advisors and other maternity staff involved in smoking cessation care. Around 5-10 staff from each site will be interviewed. Each participant will be invited to take part in one interview only. Interviews will be conducted remotely (telephone or video call), at a time convenient to the participant. Interviews will last approximately 45–60 minutes. Women and staff will be asked about their experiences of smoking cessation care, what worked well or less well, and in what situations. The researcher may share some ideas (“programme theories”) and ask for feedback. Interviews will be audio-recorded (with consent), transcribed, and anonymised. Participants can skip questions or stop at any time. Data analysis: Qualitative data will be analysed using a realist logic. Quantitative data will be analysed with descriptive statistics to answer the secondary clinical outcome Routinely collected maternity and neonatal data will be aonymised before transfer to the research team, and analysed to confirm, falsify, or refine elements of the programme theorie

Interventions

Inclusion criteria

1. Staff interviews: involved in the smoking tobacco cessation pathway as staff (as clinicians and/or non-clinicians), are 18 years or older, and English speaking. 2. Pregnant women interviews: are involved or eligible to be involved in the smoking tobacco cessation pathway as service users, are 18 years or older, and English speaking. 3. Routine electronic hospital data: maternity and neonatal service users, collected over a continuous 12-month period at each site (January 2025 to December 2025).

Exclusion criteria

1. Not English speaking 2. Aged under 18 years 3. Not willing to participate in the research

Locations

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