Health education for the prevention of secondhand smoke exposure among pregnant women visiting the antenatal clinic at a university hospital
| ISRCTN | ISRCTN32178828 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32178828 |
| Protocol serial number | Ref.No.15/0393/IRB |
| Sponsor | King Saud University, Deanship of Scientific Research |
| Funder | King Saud University |
- Submission date
- 22/02/2016
- Registration date
- 11/04/2016
- Last edited
- 07/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
One of the biggest public health threats in the world is smoking. It is a major preventable cause of disease and death all over the world. Every year, six million persons die due to the effects of tobacco. Worldwide, 40% of men and nearly 9% of women smoke tobacco. In Saudi Arabia 13% to 38% of males and 1-16% of females are smokers (although this varies with age and social status).
Although the number pregnant women in Saudi Arabia is very low (0.6%), a significantly number (31%) are frequently exposed to secondhand smoke (SHS). Tobacco smoke that is exhaled by a smoker contains more than 4000 chemicals known to be toxic or carcinogenic (i.e. known to cause cancer). SHS can affect a developing baby (fetus) directly by crossing the placenta. It is associated with premature labor, low birth weight (LBW), stillbirth, shorter infant length, smaller head size and congenital malformations (i.e. birth defects). The amount of nicotine in the air in a household where people smoke is 17 times that of a household with non-smokers. Studies have shown that many pregnant women have limited knowledge about SHS can affect the health of their unborn baby. Health education plays a key role in increasing pregnant women awareness about SHS and its harmful effect on their babies. The aim of this study is to look at whether face-to-face counselling and written information (in the form of a leaflet) about SHS for pregnant women is a more effective way of increasing their knowledge about the health risks involved than just providing written information.
Who can participate?
Women who are less than 25 weeks pregnant, do not smoke but live with someone who does smoke.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given one 15-20 minute session of face-to-face counseling and a leaflet about the health risks of SHS. Those in group 2 are given the leaflet only. All participants are asked to complete questionnaires before the study begins and again 4 weeks later. These questionnaires are designed to measure whether or not the women gain a better understanding of the risks of SHS, whether they take steps to reduce the amount of SHS they are exposed to and also whether they become less exposed to SHS.
What are the possible benefits and risks of participating?
There are no risks to taking part in this study.
Where is the study run from?
King Khalid University Hospital (Saudi Arabia)
When is the study starting and how long is it expected to run for?
September 2015 to September 2016
Who is funding the study?
King Saud University (Saudi Arabia)
Who is the main contact?
Dr Hayfaa Wahbi
hwahabi@ksu.edu.sa
Contact information
Scientific
P.O Box 2925, (internal code 34)
Riyadh
11461
Saudi Arabia
 ORCID ID |
0000-0003-2304-3364 |
|---|---|
| Phone | 00 966 114691462 |
| hwahabi@ksu.edu.sa |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effectiveness of health education for the prevention of secondhand smoke exposure among pregnant women visiting the antenatal clinic at a university hospital: a randomized controlled trial |
| Study objectives | 1. It is hypothesized that both methods of health education will be effective at improving the pregnant women knowledge about SHS exposure and its adverse effects compared to pre-education knowledge by 20-50% 2. It is hypothesized that women counseling is more effective than written information in improving pregnant women knowledge about SHS exposure 3. It is hypothesized that counseling will be effective at reducing SHS exposure among pregnant women by 20-50% |
| Ethics approval(s) | Institutional Review Board at King Saudi University, 29/10/2015, ref: 15/0393/IRB |
| Health condition(s) or problem(s) studied | Secondhand smoke exposure in pregnant women |
| Intervention | Face-to face counseling (one session which takes 15-20 minutes) and written information (leaflet) compared to only written information about health risks of exposure to secondhand smoke for pregnant women. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Reduction in time of pregnant woman exposure to secondhand smoke |
| Key secondary outcome measure(s) |
1. Rate of quitting of person/persons smoking in the presence of the pregnant woman |
| Completion date | 30/09/2016 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Arabic speaking pregnant non –smoker women 2. <25 weeks of pregnancy to give time for the intervention (1 month) and the follow up 3. Living with smoking person (husband, brother, father, son, father- in- low, house helper or other) 4. Literate 5. Willing to participate in the study |
| Key exclusion criteria | Women with unknown smoking status |
| Date of first enrolment | 01/03/2016 |
| Date of final enrolment | 01/07/2016 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
Riyadh
11461
Saudi Arabia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
