Exposure to nicotine and tobacco products during pregnancy
- Conditions
- se of nicotine and tobacco products during pregnancyPregnancy and ChildbirthUse of nicotine and tobacco products during pregnancy
- Registration Number
- ISRCTN13835237
- Lead Sponsor
- St George’s University Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 149
1. Pregnant women
2. Aged at least 16 years of age
3. Able to speak and read English
4. Do not report having had an active infection (chest infection, cold or flu, sore throat, or fever) within 24 hours of either of the two assessments
5. Willing and able to give informed consent for participation in the study
6. Meet criteria for one of six groups related to level and type of use of nicotine and tobacco products:
6.1. Group A. ‘Exclusive smokers’: Smoked more than 5 cigarettes every day for more than the last six months and have not vaped or used NRT in the last month
6.2. Group B. ‘ECs only’: Not smoked cigarettes for at least a month and have vaped every day for at least the last two weeks. Also, have not used NRT in the last month
6.3. Group C. ‘NRT only': Not smoked cigarettes for at least a month and have used NRT every day for at least the last two weeks. Also, have not vaped in the last month
6.4. Group D. Dual users of cigarettes and ECs: Smoked cigarettes on most days of the week for more than 6 months. Also, have been using e-cigarettes on most days of the week for at least the last two weeks
6.5. Group E. Dual users of cigarettes and NRT: Smoked cigarettes on most days of the week for more than 6 months. Also, have been using NRT on most days for at least the last two weeks
6.6. Group F. ‘never smokers’: Have never smoked or used any nicotine or tobacco products
Current participant exclusion criteria as of 20/10/2021:
1. Have used tobacco products other than cigarettes in the last month (e.g., cigars, heat-not-burn)
2. Have used both NRT and ECs in the last month
3. Have used nicotine free e-cigarettes in the last month
4. Report having had an active infection (chest infection, cold or flu, sore throat, or fever) within 24 hours of either of the two assessments
5. Reported as not currently smoking with an expired carbon monoxide reading of >3 parts per million (where an expired carbon monoxide reading has been obtained)
Previous participant exclusion criteria:
1. Have used tobacco products other than cigarettes in the last month (e.g., cigars, heat-not-burn)
2. Have used both NRT and ECs in the last month
3. Have used nicotine free e-cigarettes in the last month
4. Report having had an active infection (chest infection, cold or flu, sore throat, or fever) within 24 hours of either of the two assessments
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measure as of 13/12/2021:<br>Maternal urinary levels of the volatile organic compound Acrolein (metabolite HPMA) measured using urine test at the time of participation. Acrolein has two metabolites (3HPMA & 2CoEMA); the single primary outcome will be 3HPMA because 3HPMA has a higher ratio in smokers vs non-smokers compared with 2CoEMA. The metabolite 2CoEMA will be analysed as a secondary outcome.<br><br>Previous primary outcome measure:<br>Maternal urinary levels of the volatile organic compound Acrolein (metabolites HPMA and CEMA) measured using urine test at the time of participation
- Secondary Outcome Measures
Name Time Method