The trial aims to determine whether or not MiQuit (text-message support programme) is effective when offered in addition to standard behavioural support for smoking cessation in pregnancy.
Smoking in pregnancy is expensive; in the UK in 2010 the annual smoking-attributable maternal and infant health care costs were estimated at up to £87.5 million. In high income countries 13% to 25% of pregnant women smoke and rates are increasing in developing ones. In the UK in 2010 26% of pregnant women smoked with highest rates seen amongst younger, socially disadvantaged women. However, pregnancy is the life event which most motivates smoking cessation attempts and 50+% of pregnant smokers try stopping, hence smoking cessation support offered in pregnancy is likely to be especially beneficial. Regrettably, in pregnancy, there is only strong efficacy evidence for using either face-to-face or 'self-help' stop smoking support. Although nicotine replacement therapy (NRT) is widely-used by UK pregnant smokers this has at best, borderline efficacy. Self-help support (SHS) almost doubles the likelihood of smoking cessation in late pregnancy. However SHS programmes which help pregnant smokers to quit were all developed before easily-accessible technologies became widely available. Text message SHS smoking cessation programmes are highly-acceptable; those trialled with non-pregnant smokers in the US and UK have demonstrated efficacy. Unfortunately, neither programme is appropriate in pregnancy as they make no mention of pregnancy which for most pregnant smokers is the very reason they try quitting; consequently many pregnant smokers would likely find these programmes' advice irrelevant and ignore it. Funded by CRUK to remedy the lack of acceptable self-help cessation support for pregnant smokers, we developed MiQuit, a text-message, smoking cessation SHS programme for pregnant smokers. MiQuit advice is relevant to pregnancy as it is highly-tailored to gestation. We evaluated MiQuit in two RCTs. The first CRUK-funded trial (n=207) demonstrated acceptability. Subsequently, with NIHR funding we refined MiQuit and tested this in a second RCT which demonstrated the feasibility of recruiting from UK National Health Service (NHS) settings to a multi-centre RCT. Again estimated efficacy was encouraging; in MiQuit and control groups, prolonged abstinence from smoking, validated in late pregnancy was 5.4% and 2.0% respectively. To efficiently determine whether or not MiQuit works for smoking cessation, we are conducting a third RCT with an almost identical design. The efficacy of the MiQuit system will be assessed by combining the findings, using Trial Sequential Analysis methods, from this trial with the findings from the previous two MiQuit trials. Without requiring an expensive, large RCT this study will tell whether or not MiQuit is efficacious for smoking cessation in pregnancy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
1,000
MiQuit is an automated, responsive text message support programme lasting 12 weeks which sends texts containing self-help smoking cessation support and advice to participants mobile phones.
Royal Berkshire NHS Foundation Trust
Reading, Berkshire, United Kingdom
Birmingham Womens NHS Foundation Trust
Self-reported abstinence from smoking
Self-reported smoking abstinence from 4 weeks after enrolment until 36 weeks gestation, with no more than 5 cigarettes smoked in total between these time points, as reported and biochemically validated at 36 weeks using a cut-point used in the previous two trials.
Time frame: 36 weeks gestation
Self-reported abstinence from smoking at 4 weeks after randomisation
7 day abstinence reported at 4 weeks
Time frame: 4 weeks after enrolment
Abstinence from smoking at 36 weeks gestation
self-reported and biochemically validated 7 day abstinence at 36 weeks gestation
Time frame: 36 weeks gestation
Use of stop-smoking services
use of stop-smoking services
Time frame: 36 weeks gestation
Use of NHS care
Use of NHS care
Time frame: At delivery
Birth weight
Weight of infant at birth
Time frame: At delivery
Gestational age
Gestational age at birth
Time frame: At delivery
Fetal death
Miscarriage or stillbirth
Time frame: At delivery
Maternal death
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Edgbaston, Birmingham, United Kingdom
Mid Cheshire Hospitals NHS Trust
Crewe, Cheshire, United Kingdom
North Cumbria University Hospitals NHS Trust
Carlisle, Cumbria, United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, Derbyshire, United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, Devon, United Kingdom
Pennine Acute Hospitals NHS Trust
Multiple Locations, Greater Manchester, United Kingdom
East Lancashire Hospitals NHS Trust
Burnley, Lancashire, United Kingdom
United Lincolnshire Hospitals Trust
Multiple Locations, Lincolnshire, United Kingdom
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, Newcastle Upon Tyne, United Kingdom
...and 7 more locations
Death of participant
Time frame: At delivery
Health Status - baseline
Health status measured by EQ-5D-5L at baseline visit
Time frame: At hospital ante-natal appointment
Health Status - 4 weeks after randomisation
Health status measured by EQ-5D-5L at 4 weeks post randomisation
Time frame: 4 weeks post randomisation
Health Status - 36 weeks gestation
Health status measured by EQ-5D-5L at 36 weeks gestation
Time frame: 36 weeks gestation
Maternal hospital admissions
Hospital admission of participant
Time frame: At delivery
Infant hospital admission
Hospital admission of infant
Time frame: At delivery
Staff costs
Overheads and other consumables required to deliver the MiQuit intervention and usual care
Time frame: Upto 40 weeks after enrolment