The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study

NCT06297005 | Recruiting

• 1 other identifier: 21/FFP-P/10154
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 3

Brief Summary

Tobacco smoking in pregnancy is now widely accepted as having adverse health outcomes for both the mother and fetus. Tobacco smoking in pregnancy is associated with increased incidence of miscarriage, stillbirth and preterm birth as well as low birthweight, respiratory infections, wheeze and asthma in childhood. E-cigarettes are a popular method for trying to quit smoking in Ireland and there has been an explosion in the use of e-cigarettes over the past ten years. However, there is currently insufficient evidence on their long-term safety and effectiveness as a smoking cessation tool. E-cigarettes contain varying combinations of compounds and flavours which are used differently in different e-cigarette types, with unknown long-term effects. Research has shown that pregnant women perceive e-cigarettes to be a healthier option when compared with tobacco smoking. But, there is very little known about the long-term health impact of exposure of unborn babies to e-cigarettes during pregnancy. The ECHO study will determine what the long-term health outcomes are in children born to mothers who use e-cigarettes during pregnancy. Specifically, we will focus on birth, nutritional, brain development and respiratory outcomes in children. To answer this research question, the ECHO study will recruit infants born to women who use e-cigarettes during pregnancy across three maternity hospitals and follow them up over 2 years. We will invite women at their booking visit to take part in this research study. We plan to also recruit a similar number of both non-smoking and tobacco smoking pregnant women for comparison. We will record a detailed record of e-cigarette and tobacco use by women during pregnancy as well as checking smoking using special monitoring tools. After the baby is born, we will perform growth measurements, neurocognitive assessments and a respiratory questionnaire at 6 months, one year and two years of age.

Conditions

Vaping; Pregnancy Related; Pediatric Respiratory Diseases

Keywords

Vaping; Pregnancy; Paediatric health

Outcome Measures

Primary Outcomes (3)

• Incidence of preterm birth

  Obstetric

  Up to the time of birth

• Incidence of low birth weight

  Neonatal: Defined as less than the 10th centile

  Up to the time of birth

• Incidence of wheeze during the first two years of life

  Paediatric

  6, 12 and 24 months

Secondary Outcomes (24)

• Incidence of smoking and vaping

  Through study completion, up to 24 months

• Estimated foetal weight

  20 and 34 weeks gestation

• Trends in carbon monoxide levels

  Antenatal: At time of recruitment, 20 weeks, 34 weeks; postnatally: birth, 12 and 24 months

• Blood pressure measurements (both diastolic and systolic)

  At time of recruitment, 20 weeks, 34 weeks

• Urine cotinine measurements

  At time of recruitment, 20 weeks, 34 weeks and delivery

Study Arms (3)

Vapers

Women who vape during pregnancy

Smokers

Women who smoke tobacco during pregnancy

Controls

Women who neither smoke tobacco or vape during pregnany

Eligibility Criteria

• Age: 18 Years - 46 Years
• Gender Eligibility Details: Pregnant woment
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The population under scrutiny in this prospective observational cohort are adult (18 to 46 years of age) women pregnant with a singleton, non-anomalous fetus, who can understand English and can give consent to partake in the study for its duration. Participants who smoke cigarettes, use vapes and controls will be invited to partake when they attend for the booking appointment at any of the Dublin maternity hospitals. They will be given written information about the study in their first visit booking back either in electronic or hardcopy format.

You may qualify if:

• Women aged 18 or greater and less than 46 years of age at booking
• Pregnant with a singleton fetus
• Smokers (exhaled CO reading of greater than or equal to 4) or
• Self-reported vaper or
• Dual user (smoker/vaper)
• Non-smokers
• Able to understand and read English.
• Willing to agree to follow-up for the two-year duration of the study in the postnatal period (ie. unlikely to move out of the catchment area).

You may not qualify if:

• Women pregnant with twins or higher order multiples
• Late bookers - defined as booking after 24+0 weeks' gestational age
• Fetus or infant diagnosed with a major congenital abnormality (major structural abnormality, ie congenital diaphragmatic hernia (CDH), omphalocele, major cardiac defects ie. which require immediate admission to NICU +/- transfer to cardiology for surgery, chromosomal abnormalities, syndromes - Turner's/Noonan's) or a lethal fetal anomaly
• Any inherited disorder of metabolism or Cystic Fibrosis on Guthrie Card/ neonatal blood spot screening
• History of significant medical disorder in pregnancy e.g. cardiac, haematological, or endocrine disease (including gestational diabetes requiring insulin)
• Significant maternal psychiatric disorder, e.g. delusional or psychotic disorders, severe depression requiring hospitalisation, use of \>1 psychotropic drugs for treatment
• Serious co-morbid addiction issues e.g. opiate abuse, methadone maintenance program
• Severe intellectual disability or lack of capacity

Sponsors & Collaborators

• University College Dublin: lead
• Royal College of Surgeons, Ireland: collaborator

Study Sites (3)

Rotunda Hospital

Dublin, D01 P5W9, Ireland

RECRUITING

National Maternity Hospital, Holles Street

Dublin, D02 YH21, Ireland

RECRUITING

Coombe Womens Hospital

Dublin, D08 XW7X, Ireland

RECRUITING

Related Publications (25)

• Agarwal S, Trolice MP, Lindheim SR. E-cigarette use in reproductive-aged women and pregnancy: a rising health concern. Fertil Steril. 2020 Jun;113(6):1133-1134. doi: 10.1016/j.fertnstert.2020.01.031. Epub 2020 Mar 25. No abstract available.

  PMID: 32222252 BACKGROUND

• Gould GS, Havard A, Lim LL, The Psanz Smoking In Pregnancy Expert Group, Kumar R. Exposure to Tobacco, Environmental Tobacco Smoke and Nicotine in Pregnancy: A Pragmatic Overview of Reviews of Maternal and Child Outcomes, Effectiveness of Interventions and Barriers and Facilitators to Quitting. Int J Environ Res Public Health. 2020 Mar 19;17(6):2034. doi: 10.3390/ijerph17062034.

  PMID: 32204415 BACKGROUND

• Rogers JM. Tobacco and pregnancy. Reprod Toxicol. 2009 Sep;28(2):152-60. doi: 10.1016/j.reprotox.2009.03.012. Epub 2009 Apr 9.

  PMID: 19450949 BACKGROUND

• Holbrook BD. The effects of nicotine on human fetal development. Birth Defects Res C Embryo Today. 2016 Jun;108(2):181-92. doi: 10.1002/bdrc.21128. Epub 2016 Jun 13.

  PMID: 27297020 BACKGROUND

• Hsu G, Sun JY, Zhu SH. Evolution of Electronic Cigarette Brands From 2013-2014 to 2016-2017: Analysis of Brand Websites. J Med Internet Res. 2018 Mar 12;20(3):e80. doi: 10.2196/jmir.8550.

  PMID: 29530840 BACKGROUND

• Ebell MH. e-Cigarettes More Effective Than Nicotine Replacement for Cessation of Tobacco Use in Adults. Am Fam Physician. 2019 Oct 1;100(7):442. No abstract available.

  PMID: 31573159 BACKGROUND

• Hajek P, Phillips-Waller A, Przulj D, Pesola F, Myers Smith K, Bisal N, Li J, Parrott S, Sasieni P, Dawkins L, Ross L, Goniewicz M, Wu Q, McRobbie HJ. A Randomized Trial of E-Cigarettes versus Nicotine-Replacement Therapy. N Engl J Med. 2019 Feb 14;380(7):629-637. doi: 10.1056/NEJMoa1808779. Epub 2019 Jan 30.

  PMID: 30699054 BACKGROUND

• Ibrahim S, Habiballah M, Sayed IE. Efficacy of Electronic Cigarettes for Smoking Cessation: A Systematic Review and Meta-Analysis. Am J Health Promot. 2021 Mar;35(3):442-455. doi: 10.1177/0890117120980289. Epub 2020 Dec 17.

  PMID: 33327728 BACKGROUND

• Wang RJ, Bhadriraju S, Glantz SA. E-Cigarette Use and Adult Cigarette Smoking Cessation: A Meta-Analysis. Am J Public Health. 2021 Feb;111(2):230-246. doi: 10.2105/AJPH.2020.305999. Epub 2020 Dec 22.

  PMID: 33351653 BACKGROUND

• Hartmann-Boyce J, McRobbie H, Lindson N, Bullen C, Begh R, Theodoulou A, Notley C, Rigotti NA, Turner T, Butler AR, Hajek P. Electronic cigarettes for smoking cessation. Cochrane Database Syst Rev. 2020 Oct 14;10(10):CD010216. doi: 10.1002/14651858.CD010216.pub4.

  PMID: 33052602 BACKGROUND

• Tsai M, Byun MK, Shin J, Crotty Alexander LE. Effects of e-cigarettes and vaping devices on cardiac and pulmonary physiology. J Physiol. 2020 Nov;598(22):5039-5062. doi: 10.1113/JP279754. Epub 2020 Oct 12.

  PMID: 32975834 BACKGROUND

• Gotts JE, Jordt SE, McConnell R, Tarran R. What are the respiratory effects of e-cigarettes? BMJ. 2019 Sep 30;366:l5275. doi: 10.1136/bmj.l5275.

  PMID: 31570493 BACKGROUND

• Chun LF, Moazed F, Calfee CS, Matthay MA, Gotts JE. Pulmonary toxicity of e-cigarettes. Am J Physiol Lung Cell Mol Physiol. 2017 Aug 1;313(2):L193-L206. doi: 10.1152/ajplung.00071.2017. Epub 2017 May 18.

  PMID: 28522559 BACKGROUND

• Ruszkiewicz JA, Zhang Z, Goncalves FM, Tizabi Y, Zelikoff JT, Aschner M. Neurotoxicity of e-cigarettes. Food Chem Toxicol. 2020 Apr;138:111245. doi: 10.1016/j.fct.2020.111245. Epub 2020 Mar 5.

  PMID: 32145355 BACKGROUND

• Breland A, McCubbin A, Ashford K. Electronic nicotine delivery systems and pregnancy: Recent research on perceptions, cessation, and toxicant delivery. Birth Defects Res. 2019 Oct 15;111(17):1284-1293. doi: 10.1002/bdr2.1561. Epub 2019 Jul 31.

  PMID: 31364280 BACKGROUND

• Greene RM, Pisano MM. Developmental toxicity of e-cigarette aerosols. Birth Defects Res. 2019 Oct 15;111(17):1294-1301. doi: 10.1002/bdr2.1571. Epub 2019 Aug 9.

  PMID: 31400084 BACKGROUND

• McDonnell BP, Dicker P, Regan CL. Electronic cigarettes and obstetric outcomes: a prospective observational study. BJOG. 2020 May;127(6):750-756. doi: 10.1111/1471-0528.16110. Epub 2020 Feb 9.

  PMID: 32036628 BACKGROUND

• Wang X, Lee NL, Burstyn I. Smoking and use of electronic cigarettes (vaping) in relation to preterm birth and small-for-gestational-age in a 2016 U.S. national sample. Prev Med. 2020 May;134:106041. doi: 10.1016/j.ypmed.2020.106041. Epub 2020 Feb 24.

  PMID: 32105682 BACKGROUND

• Kim S, Oancea SC. Electronic cigarettes may not be a "safer alternative" of conventional cigarettes during pregnancy: evidence from the nationally representative PRAMS data. BMC Pregnancy Childbirth. 2020 Sep 23;20(1):557. doi: 10.1186/s12884-020-03247-6.

  PMID: 32967660 BACKGROUND

• Cooper S, Lewis S, Thornton JG, Marlow N, Watts K, Britton J, Grainge MJ, Taggar J, Essex H, Parrott S, Dickinson A, Whitemore R, Coleman T; Smoking, Nicotine and Pregnancy Trial Team. The SNAP trial: a randomised placebo-controlled trial of nicotine replacement therapy in pregnancy--clinical effectiveness and safety until 2 years after delivery, with economic evaluation. Health Technol Assess. 2014 Aug;18(54):1-128. doi: 10.3310/hta18540.

  PMID: 25158081 BACKGROUND

• Cooper S, Taggar J, Lewis S, Marlow N, Dickinson A, Whitemore R, Coleman T; Smoking, Nicotine and Pregnancy (SNAP) Trial Team. Effect of nicotine patches in pregnancy on infant and maternal outcomes at 2 years: follow-up from the randomised, double-blind, placebo-controlled SNAP trial. Lancet Respir Med. 2014 Sep;2(9):728-37. doi: 10.1016/S2213-2600(14)70157-2. Epub 2014 Aug 10.

  PMID: 25127405 BACKGROUND

• Kapaya M, D'Angelo DV, Tong VT, England L, Ruffo N, Cox S, Warner L, Bombard J, Guthrie T, Lampkins A, King BA. Use of Electronic Vapor Products Before, During, and After Pregnancy Among Women with a Recent Live Birth - Oklahoma and Texas, 2015. MMWR Morb Mortal Wkly Rep. 2019 Mar 1;68(8):189-194. doi: 10.15585/mmwr.mm6808a1.

  PMID: 30817748 BACKGROUND

• Cardenas VM, Fischbach LA, Chowdhury P. The use of electronic nicotine delivery systems during pregnancy and the reproductive outcomes: A systematic review of the literature. Tob Induc Dis. 2019 Jul 1;17:52. doi: 10.18332/tid/104724. eCollection 2019.

  PMID: 31582941 BACKGROUND

• Opondo C, Harrison S, Alderdice F, Carson C, Quigley MA. Electronic cigarette use (vaping) and patterns of tobacco cigarette smoking in pregnancy-evidence from a population-based maternity survey in England. PLoS One. 2021 Jun 4;16(6):e0252817. doi: 10.1371/journal.pone.0252817. eCollection 2021.

  PMID: 34086809 BACKGROUND

• Healy EF, O'Connell A, Yousef MS, Reddin A, Boyle M, Coleman T, Doolan A, Fitzpatrick P, Frazer K, Higgins S, Kelleher C, Malone FD, O'Currain E, Seguardo R, Walsh J, Cox D, Downes M, Regan C. The impact of electronic cigarettes on pregnancy and childhood health outcomes: the ECHO study-a protocol for a multicentre, prospective, observational, cohort. Arch Gynecol Obstet. 2025 Sep;312(3):927-935. doi: 10.1007/s00404-025-08066-8. Epub 2025 Jun 20.

  PMID: 40540019 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine for cotinine measurements

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Des Cox, MB BCh BAO

  University College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Des W Cox, MB BCh BAO

CONTACT

+35314282638; desmond.cox@ucd.ie

Carmen Regan, FRCOG

CONTACT

cregan@coombe.ie

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 6, 2024
• Study Start: October 9, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (3)