| Primary | Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. | The primary smoking outcome measure will be the number of participants reporting continuous abstinence from smoking from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation at approximately 36 weeks gestation. | All participants were included in analysis. Participants lost to follow up were assumed to be smoking. | Posted | | Count of Participants | | Participants | | 36 weeks gestation | | | | ID | Title | Description |
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| OG000 | MiQuit | 12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement. | | OG001 | Control | Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Adjusted odds ratio | 2.70 | | | 2-Sided | 95 | 0.93 | 9.35 | | | Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported. | | Superiority | | |
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| Secondary | Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Self-report. | The number of participants reporting continuous abstinence from smoking from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation), self-reported. | All participants were included in analysis. Participants lost to follow up were assumed to be smoking. | Posted | | Count of Participants | | Participants | | 36 weeks gestation | | | | ID | Title | Description |
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| OG000 | MiQuit | 12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement. | | OG001 | Control | Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking |
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| Secondary | 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Self-report. | The number of participants reporting 7-day abstinence from smoking at the end of pregnancy (approximately 36 weeks gestation), self-reported. | All participants were included in analysis. Participants lost to follow up were assumed to be smoking. | Posted | | Count of Participants | | Participants | | 36 weeks gestation | | | | ID | Title | Description |
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| OG000 | MiQuit | 12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement. | | OG001 | Control | Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking |
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| Secondary | 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Biochemically Validated. | The number of participants reporting 7-day abstinence from smoking at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation. | All participants were included in analysis. Participants lost to follow up were assumed to be smoking. | Posted | | Count of Participants | | Participants | | 36 weeks gestation | | | | ID | Title | Description |
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| OG000 | MiQuit | 12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement. | | OG001 | Control | Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking |
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| Secondary | 7-day Point Prevalence Abstinence From Smoking Reported at 4 Weeks Post-randomization, Self-report. | The number of participants reporting 7-day abstinence from smoking at 4 weeks after randomisation, self-reported. | All participants were included in analysis. Participants lost to follow up were assumed to be smoking. | Posted | | Count of Participants | | Participants | | 4 weeks post-randomisation | | | | ID | Title | Description |
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| OG000 | MiQuit | 12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement. | | OG001 | Control | Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking |
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| Secondary | 7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Self-report. | The number of participants reporting 7-day abstinence from smoking at both 4 weeks after randomisation and at follow up at the end of pregnancy (approximately 36 weeks gestation), self-reported. | All participants were included in analysis. Participants lost to follow up were assumed to be smoking. | Posted | | Count of Participants | | Participants | | 36 weeks gestation | | | | ID | Title | Description |
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| OG000 | MiQuit | 12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement. | | OG001 | Control | Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking |
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| Secondary | 7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Biochemically Validated at Late Pregnancy. | The number of participants reporting 7-day abstinence from smoking at both 4 weeks after randomisation and at follow up at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation at approximately 36 weeks gestation. | All participants were included in analysis. Participants lost to follow up were assumed to be smoking. | Posted | | Count of Participants | | Participants | | 36 weeks gestation | | | | ID | Title | Description |
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| OG000 | MiQuit | 12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement. | | OG001 | Control | Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking |
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| Secondary | Number of 24 Hour Quit Attempts | Number of short-term, 24 hour quit attempts noted per participant, from baseline until follow up at the end of pregnancy (approximately 36 weeks gestation). | Outcomes are calculated out of 254 participants with response data at late pregnancy follow up (124 MiQuit, 130 Standard Care). | Posted | | Median | Inter-Quartile Range | number of events reported | | 36 weeks gestation | | | | ID | Title | Description |
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| OG000 | MiQuit | 12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement. | | OG001 | Control | Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking |
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| Secondary | Reported Use of NHS and Other (Non-trial) Cessation Support | Reported use of any NHS cessation support or other (non-trial) cessation support (e.g. non-NHS websites), from baseline until follow up at the end of pregnancy (approximately 36 weeks gestation). | Outcomes are calculated out of 254 participants with response data at late pregnancy follow up (124 MiQuit, 130 Standard Care). | Posted | | Count of Participants | | Participants | | 36 weeks gestation | | | | ID | Title | Description |
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| OG000 | MiQuit | 12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement. | | OG001 | Control | Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking |
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| Secondary | Number of Requests to Stop Text Support | The number of participants in the trial arm who discontinued the text support prematurely, from baseline until follow up at the end of pregnancy (approximately 36 weeks gestation). | All participants allocated to the trial arm were included in analysis. | Posted | | Count of Participants | | Participants | | 36 weeks gestation | | | | ID | Title | Description |
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| OG000 | MiQuit | 12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care MiQuit: MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement. |
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