Condition category
Mental and Behavioural Disorders
Date applied
26/05/2016
Date assigned
26/05/2016
Last edited
26/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Miss Ciara Reynolds

ORCID ID

Contact details

Coombe Women and Infants University Hospital
Cork Street
Dublin 8
Dublin
8
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Stopping Smoking To Optimise Pregnancy (SSTOP): a randomised control trial

Acronym

SSTOP

Study hypothesis

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

Coombe Women and Infant University Hospital Research Ethics Committee, 14/10/2015, Ref: 17-2015

Study design

Single-centre interventional randomised control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Smoking cessation in pregnant women

Intervention

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

Phase

Drug names

Primary outcome measures

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

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 trial start date

02/06/2015

Overall trial end date

01/03/2018

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

220 pregnant women

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

Recruitment start date

01/05/2016

Recruitment end date

01/03/2018

Locations

Countries of recruitment

Ireland

Trial participating centre

The Coombe Women and Infants University Hospital
Cork Street
Dublin
4
Ireland

Sponsor information

Organisation

Coombe Women and Infants University Hospital (Ireland)

Sponsor details

Cork Street
Dublin 8
Dublin
8
Ireland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Coombe Women and Infants University Hospital (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes