Condition category
Pregnancy and Childbirth
Date applied
25/11/2019
Date assigned
27/11/2019
Last edited
26/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Health professionals and pregnant women are cautious about recommending or using e-cigarettes (ECs) in pregnancy, due to lack of detailed safety information. The main aim of the study is to measure toxins and cancer causing substances in the urine of women who used to smoke and now just use ECs compared with women who just smoke.

Who can participate?
Pregnant women who are smokers, users of ECs, nicotine replacement therapy, smoke and use ECs, or have never smoked.

What does the study involve?
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 collected sample will be used if available) and to complete a questionnaire (about themselves and use of nicotine/tobacco products, alcohol, cannabis). They will also be asked to blow into a device that measures exposure to tobacco smoke. They will then be asked to meet with the researcher again at a further routine antenatal visit, in order to repeat the assessments.

What are the possible benefits and risks of participating?
None

Where is the study run from?
1. St George’s University Hospitals NHS Foundation Trust, UK
2. Lancashire teaching Hospitals NHS Foundation Trust, UK
3. Bradford Teaching Hospital NHS Foundation Trust, UK
4. The Newcastle Upon Tyne Hospitals NHS Foundation Trust, UK
5. Gateshead Health NHS Foundation Trust, UK

When is the study starting and how long is it expected to run for?
November 2019 to April 2021

Who is funding the study?
Cancer Research UK

Who is the main contact?
Prof. Michael Ussher
mussher@sgul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Ussher

ORCID ID

http://orcid.org/0000-0002-0995-7955

Contact details

Population Health Research Insititute
St George's University of London
Cranmer Terrace
London
SW17 ORE
United Kingdom
+44 (0)20 8725 5605
mussher@sgul.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

V2.0; IRAS project ID: 269631

Study information

Scientific title

Maternal exposure to carcinogens, toxicants and nicotine during pregnancy among e-cigarette users, smokers, nicotine replacement therapy users and among those who have never used nicotine or tobacco products

Acronym

Study hypothesis

During pregnancy, we hypothesise that eletronic cigarette (EC) users will have significantly lower levels of urinary acrolein than smokers. As secondary objectives we will explore levels of a range of biomarkers in exclusive EC users compared with exclusive smokers, dual users of cigarettes and ECs, exclusive nicotine replacement therapy (NRT) users; dual users of cigarettes and NRT, and ‘never users of tobacco or nicotine products’. Generally, the hypothesis is that less tobacco smoke exposure will equate to less toxin and carcinogen exposure.

Ethics approval

Approved 29/10/2019, London - Brighton & Sussex Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH; +44(0)207 104 8052; NRESCommittee.SECoast-BrightonandSussex@nhs.net), ref: 19/LO/1599

Study design

Observational cross-sectional multicentre study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

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

Condition

Use of nicotine and tobacco products during pregnancy

Intervention

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 collected sample can be used if available) and to complete a questionnaire (about themselves and use of nicotine/tobacco products, alcohol, cannabis). They will also be asked to blow into a device that measures exposure to tobacco smoke. They will then be asked to meet with the researcher again at a further routine antenatal visit, in order to repeat the assessments.
Urine samples will be stored in a freezer and at the end of the study will be sent to an external laboratory for testing. The results will provide valuable information for women who are pregnant, for healthcare professionals who care for those women and for regulators, about the potential safety of using ECs during pregnancy.

Intervention type

Other

Phase

Drug names

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 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 chorionic gonadotropin (hCG)
7. Pregnancy-associated plasma protein A (PAPPA-A)
8. Use of alcohol and cannabinoids

Overall trial start date

01/09/2019

Overall trial end date

30/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Mixed

Gender

Female

Target number of participants

204

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

Recruitment start date

14/11/2019

Recruitment end date

31/10/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George’s University Hospitals NHS Foundation Trust
Blackshaw Road
London
SW17 0QT
United Kingdom

Trial participating centre

Lancashire teaching Hospitals NHS Foundation Trust
Preston Royal Hospital Sharoe Green Lane
Preston
PR2 9HT
United Kingdom

Trial participating centre

Bradford Teaching Hospital NHS Foundation Trust
Bradford Royal Infirmary Smith Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

The Newcastle Upon Tyne Hospitals NHS Foundation Trust
The Royal Victoria Infirmary Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

Gateshead Health NHS Foundation Trust
Queen Elizabeth Hospital Queen Elizabeth Avenue Sheriff Hill
Gateshead
NE9 6SX
United Kingdom

Sponsor information

Organisation

St George’s University Hospitals NHS Foundation Trust

Sponsor details

Blackshaw Road
London
SW17 0QT
United Kingdom
+44(0)208 725 0892
sahollin@sgul.ac.uk

Sponsor type

Hospital/treatment centre

Website

https://www.stgeorges.nhs.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The findings will be presented at international conferences (e.g., Society for Research on Nicotine and Tobacco) and, towards the end of the study period, will be submitted to a high impact journal (e.g., BMJ). We will also disseminate the findings to policy makers, NGOs and health professionals.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available as consent has not be obtained for this purpose.

Intention to publish date

30/04/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

26/11/2019: Trial’s existence confirmed by Cancer Research UK