Stopping smoking to optimise pregnancy
| ISRCTN | ISRCTN49741320 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49741320 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/05/2016
- Registration date
- 26/05/2016
- Last edited
- 19/09/2018
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Plain English summary as of 18/09/2018:
Background and study aims
About 13% of women having babies in the Coombe Hospital smoke cigarettes. This is associated with an increased risk of having a baby weighing less than 2.5kg at birth, and of having a baby before he or she is due to be born (premature birth). Both low birth weight and preterm birth are the leading causes of health problems for babies, including failure of the baby to reach its growth potential, or even stillbirth. Smoking can lead to an increased risk of pregnancy-related problems for the mother as well, including separation of the placenta from the wall of the womb, causing bleeding. It has been shown that there is a relationship between the number of cigarettes smoked per day and the amount of risk placed on the pregnancy. Stopping smoking has well-known benefits, as does “cutting down”. There is, however, no proven cost effective way to help women to cut down or stop smoking during pregnancy. The aim of this study is to assess whether receiving smoking cessation advice and social media support via a secret website is more effective than the usual way of delivering smoking cessation advice (with pamphlets at the first pregnancy visit, and through doctors). We also hope to show that smoking cessation will result in fewer pregnancies complicated by a low birthweight baby or a baby born too early.
Who can participate?
Pregnant women aged over 18 who smoke
What does the study involve?
Participants are randomly allocated to either the control group or the intervention group. The control group receive standard antenatal care in which they receive routine advice on diet, exercise and smoking cessation. The intervention group receive standard antenatal care along with an individualised counselling session and social media support via a private website. The individualised counselling session includes advice on how to quit smoking, smoking cessation resources and the benefits of smoking cessation. At the first antenatal appointment the women are also invited to join a website for smoking cessation support which includes reasons to stop smoking, methods to stop smoking and also allows for interaction between members of the group. Participants are seen by the research team once at less than 24 weeks gestation and at one other time point in pregnancy to have measurements (weight, height, body composition), a urine test, a breath test, and to complete food diaries and questionnaires.
What are the possible benefits and risks of participating?
The possible benefits of participation include increased knowledge of the health risks, adverse pregnancy outcomes and financial cost of continuing to smoke during pregnancy. There are no known adverse risks of participation.
Where is the study run from?
The Coombe Women and Infants University Hospital (Ireland)
When is the study starting and how long is it expected to run for?
June 2015 to March 2018
Who is funding the study?
Coombe Women and Infants University Hospital (Ireland)
Who is the main contact?
Ciara Reynolds
Previous plain English summary:
Background and study aims
About 13% of women having babies in the Coombe Hospital smoke cigarettes. This is associated with an increased risk of having a baby weighing less than 2.5kg at birth, and of having a baby before he or she is due to be born (premature birth). Both low birth weight and preterm birth are the leading causes of health problems for babies, including failure of the baby to reach its growth potential, or even stillbirth. Smoking can lead to an increased risk of pregnancy-related problems for the mother as well, including high blood pressure or separation of the placenta from the wall of the womb, causing bleeding. It has been shown that there is a relationship between the number of cigarettes smoked per day and the amount of risk placed on the pregnancy. Stopping smoking has well-known benefits, as does “cutting down”. There is, however, no proven cost effective way to help women to cut down or stop smoking during pregnancy. The aim of this study is to assess whether receiving smoking cessation advice and social media support via a secret website is more effective than the usual way of delivering smoking cessation advice (with pamphlets at the first pregnancy visit, and through doctors). We also hope to show that smoking cessation will result in fewer pregnancies complicated by a low birthweight baby or a baby born too early.
Who can participate?
Pregnant women aged over 18 who smoke
What does the study involve?
Participants are randomly allocated to either the control group or the intervention group. The control group receive standard antenatal care in which they receive routine advice on diet, exercise and smoking cessation. The intervention group receive standard antenatal care along with an individualised counselling session and social media support via a private website. The individualised counselling session includes advice on how to quit smoking, smoking cessation resources and the benefits of smoking cessation. At the 24 weeks gestation antenatal appointment the women are also invited to join a website for smoking cessation support which includes reasons to stop smoking, methods to stop smoking and also allows for interaction between members of the group. Participants are seen by the research team once at less than 24 weeks gestation, at one other time point in pregnancy, at delivery, and 6 weeks after delivery, to have measurements (weight, height, body composition), a urine test, a breath test, and to complete food diaries and questionnaires.
What are the possible benefits and risks of participating?
The possible benefits of participation include increased knowledge of the health risks, adverse pregnancy outcomes and financial cost of continuing to smoke during pregnancy. There are no known adverse risks of participation.
Where is the study run from?
The Coombe Women and Infants University Hospital (Ireland)
When is the study starting and how long is it expected to run for?
June 2015 to March 2018
Who is funding the study?
Coombe Women and Infants University Hospital (Ireland)
Who is the main contact?
Ciara Reynolds
Contact information
Public
Coombe Women and Infants University Hospital
Cork Street
Dublin 8
Dublin
8
Ireland
Study information
| Study design | Single-centre interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Stopping Smoking To Optimise Pregnancy (SSTOP): a randomised controlled trial |
| Study acronym | SSTOP |
| Study objectives | The hypothesis is that smoking cessation support, including an individualised counselling session and social media support via a private website (intervention group), will result in more women completely ceasing smoking compared with women receiving routine antenatal care alone (usual care group). |
| Ethics approval(s) | Coombe Women and Infant University Hospital Research Ethics Committee, 14/10/2015, Ref: 17-2015 |
| Health condition(s) or problem(s) studied | Smoking cessation in pregnant women |
| Intervention | Interventions as of 18/09/2018: The control group will receive standard antenatal care in which they will receive routine advice on diet, exercise and smoking cessation. Women allocated to the intervention group will receive standard antenatal care along with an individualised counselling session and social media support via a private website. The individualised counselling session will include advice on how to quit smoking, smoking cessation resources and benefits of smoking cessation. At the first antenatal appointment the women will also be invited to join a website for smoking cessation support which will include pregnancy specific and evidence based information on reasons to cease smoking, methods to cease smoking and will also allow for interaction between members of the group. Previous interventions: The control group will receive standard antenatal care in which they will receive routine advice on diet, exercise and smoking cessation. Women allocated to the intervention group will receive standard antenatal care along with an individualised counselling session and social media support via a private website. The individualised counselling session will include advice on how to quit smoking, smoking cessation resources and benefits of smoking cessation. At the 24 weeks gestation antenatal appointment the women will also be invited to join a website for smoking cessation support which will include pregnancy specific and evidence based information on reasons to cease smoking, methods to cease smoking and will also allow for interaction between members of the group. |
| Intervention type | Behavioural |
| Primary outcome measure | Primary outcome measure as of 18/09/2018: Smoking cessation measured using urine samples and carbon monoxide breath tests. These will be collected at <17 weeks gestation and two months post recruitment. Previous primary outcome measure: Smoking cessation measured using urine samples and carbon monoxide breath tests. These will be collected at <24 weeks gestation, two months post recruitment, at delivery and 6 weeks postnatal. |
| Secondary outcome measures | Secondary outcome measure as of 19/09/2018: 1. Perceived stress score will be collected by questionnaire at <17 weeks gestation and two months post recruitment 2. Nicotine dependency will be collected by questionnaire at <17 weeks gestation and two months post recruitment 3. Preterm birth collected post-delivery from hospital's computerised system 4. Birthweight collected post-delivery from hospital's computerised system 5. Perinatal mortality collected post-delivery from hospital's computerised system 6. NICU admissions collected post-delivery from hospital's computerised system Previous secondary outcome measure: 1. Perceived stress score will be collected by questionnaire at <24 weeks gestation, two months post recruitment, at delivery and 6 weeks postnatal 2. Nicotine dependency will be collected by questionnaire at <24 weeks gestation, two months post recruitment, at delivery and 6 weeks postnatal 3. Preterm birth collected post-delivery from hospital's computerised system 4. Birthweight collected post-delivery from hospital's computerised system 5. Perinatal mortality collected post-delivery from hospital's computerised system 6. NICU admissions collected post-delivery from hospital's computerised system |
| Overall study start date | 02/06/2015 |
| Completion date | 30/09/2016 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 220 pregnant women |
| Key inclusion criteria | Participant inclusion criteria as of 18/09/2018: 1. Age >18 years 2. <17 weeks gestation 3. Fluent in English 4. Ongoing singleton pregnancy 5. Self-reported smoker 6. Able to give written informed consent Previous participant inclusion criteria: 1. Age >18 years 2. <24 weeks gestation 3. Fluent in English 4. Ongoing singleton pregnancy 5. Self-reported smoker 6. Able to give written informed consent |
| Key exclusion criteria | Participant exclusion criteria as of 18/09/2018: 1. Age <18 years 2. >17 weeks gestation 3. Non-English speaking 4. Multiple pregnancy 5. Non-smoker 6. Unable to give written informed consent Previous participant exclusion criteria: 1. Age <18 years 2. >24 weeks gestation 3. Non-English speaking 4. Multiple pregnancy 5. Non-smoker 6. Unable to give written informed consent |
| Date of first enrolment | 01/05/2016 |
| Date of final enrolment | 30/09/2016 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Dublin
4
Ireland
Sponsor information
Hospital/treatment centre
Cork Street
Dublin 8
Dublin
8
Ireland
"ROR" |
https://ror.org/00bx71042 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Editorial Notes
19/09/2018: The following changes were made to the trial record:
1. The interventions were updated
2. The primary outcome measures were updated
3. The secondary outcome measures were updated
4. The participant inclusion criteria was updated
5. The participant exclusion criteria was updated
6. The plain English summary was updated
7. Recruitment ended on 30/09/2016 due to insufficient recruitment
8. The trial ended on 30/09/2016 due to insufficient recruitment
23/10/2017: Internal review.
