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Completed

NCT Number: NCT03231553

Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy

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.

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Berkshire NHS Foundation Trust, Reading, Berkshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant and less than 25 weeks gestation
  • Smoking at least 5 cigarettes per day pre-pregnancy
  • Smoking at least 1 cigarette on a typical day during pregnancy
  • Aged 16 or over
  • Agrees to accept information to assist cessation
  • Owns or has primary use of a mobile phone
  • Familiar with sending and receiving text messages
  • Able to understand written English (text messages are in English only) and consent issues explained in English.
  • Able to give informed consent

Exclusion criteria

  • Already enrolled in another text service to assist smoking cessation
  • Already enrolled in a smoking cessation study
  • Having already participated in the study in an earlier pregnancy

Treatment and study plan

MiQuit text message support programme

Other

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.

Primary outcomes

  1. Self-reported abstinence from smoking

    Time frame: 36 weeks gestation

    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.

Secondary outcomes

  1. Self-reported abstinence from smoking at 4 weeks after randomisation

    Time frame: 4 weeks after enrolment

    7 day abstinence reported at 4 weeks

  2. Abstinence from smoking at 36 weeks gestation

    Time frame: 36 weeks gestation

    self-reported and biochemically validated 7 day abstinence at 36 weeks gestation

  3. Use of stop-smoking services

    Time frame: 36 weeks gestation

    use of stop-smoking services

  4. Use of NHS care

    Time frame: At delivery

    Use of NHS care

  5. Birth weight

    Time frame: At delivery

    Weight of infant at birth

  6. Gestational age

    Time frame: At delivery

    Gestational age at birth

  7. Fetal death

    Time frame: At delivery

    Miscarriage or stillbirth

  8. Maternal death

    Time frame: At delivery

    Death of participant

  9. Health Status - baseline

    Time frame: At hospital ante-natal appointment

    Health status measured by EQ-5D-5L at baseline visit

  10. Health Status - 4 weeks after randomisation

    Time frame: 4 weeks post randomisation

    Health status measured by EQ-5D-5L at 4 weeks post randomisation

  11. Health Status - 36 weeks gestation

    Time frame: 36 weeks gestation

    Health status measured by EQ-5D-5L at 36 weeks gestation

  12. Maternal hospital admissions

    Time frame: At delivery

    Hospital admission of participant

  13. Infant hospital admission

    Time frame: At delivery

    Hospital admission of infant

  14. Staff costs

    Time frame: Upto 40 weeks after enrolment

    Overheads and other consumables required to deliver the MiQuit intervention and usual care

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

RCT and Meta-analysis Testing Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2017
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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