Use of nicotine and tobacco products during pregnancy Pregnancy and Childbirth Use of nicotine and tobacco products during pregnancy
Conditions
Interventions
Pregnant women will be invited to take part when they attend a routine antenatal appointment. If they agree to participate, they will be asked by a researcher to provide a urine sample (or a routinely
Sponsors
St George’s University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 13/12/2021: 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. Previous primary outcome measure: Maternal urinary levels of the volatile organic compound Acrolein (metabolites HPMA and CEMA) measured using urine test at the time of participation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 13/12/2021: All tested in maternal urine at time of participation: 1. Tobacco exposure will be assessed with a test for minor tobacco alkaloids (anabasine, anatabine), expired carbon monoxide levels 2. Levels of nicotine, cotinine and their metabolites, to derive total nicotine equivalents 3. Nicotine metabolite ratio (NMR) 4. Two tobacco-specific nitrosamines (TSNAs) (i.e., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNAL) and N-nitrosonornicotine (NNN)), two heavy metals (i.e., cadmium (Cd) and lead (Pb)) and one polycyclic aromatic hydrocarbon (PAH) (i.e., 2-naphthol) 5. 13 volatile organic compounds (VOCs) parent (metabolite): acrolein (2CoEMA), 1,3-butadiene (MHB3), acrylamide (AAMA), acrylonitrile (CYMA), Benzene (PMA), crotonaldehyde (HPMM), cyanide (ATCA), isoprene (IPM3), ethylbenzene (PHGA), propylene oxide (HPM2), styrene (MADA), toluene/benzyl alcohol (BMA), and m,p-xylene (34MH) 6. Human chorionic gonadotropin (hCG) 7. Pregnancy-associated plasma protein A (PAPPA-A) 8. Use of alcohol and cannabinoids Previous secondary outcome measures: All tested in maternal urine at time of participation: 1. Tobacco exposure will be assessed with a test for minor tobacco alkaloids (anabasine, anatabine), expired carbon monoxide levels 2. Levels of nicotine, cotinine and their metabolites, to derive total nicotine equivalents 3. Nicotine metabolite ratio (NMR) 4. Two tobacco-specific nitrosamines (TSNAs) (i.e., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNAL) and N-nitrosonornicotine (NNN)), two heavy metals (i.e., cadmium (Cd) and lead (Pb)) and one polycyclic aromatic hydrocarbon (PAH) (i.e., 2-naphthol) 5. 12 volatile organic compounds (VOCs) parent (metabolite): 1,3-butadiene (MHB3), acrylamide (AAMA), acrylonitrile (CYMA), Benzene (PMA), crotonaldehyde (HPMM), cyanide (ATCA), isoprene (IPM3), ethylbenzene (PHGA), propylene oxide (HPM2), styrene (MADA), toluene/benzyl alcohol (BMA), and m,p-xylene (34MH) 6. Human c | — |
Countries
England, United Kingdom
Outcome results
None listed