The association of electronic cigarettes use during pregnancy and its influence on birth weight. Protocol for a prospective cohort study.

Table of contents

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1. INTRODUCTION                      3

1.1  Risks of tobacco        3

1.2  Risks of tobacco in pregnancy      3

1.3  Cessation techniques       3

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1.4  Drugs in cessation       3

1.5  Electronic cigarettes       4

1.6  Electronic cigarette safety      5

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1.7  Electronic cigarette safety in pregnancy     5

2. STUDY AIM         6 

3. METHODS         7

3.1  Study design        7

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3.2  Setting         7

3.3 Participants        8

3.4  Variables             10

3.5  Data Sources/measurement      10

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3.6  Bias         11

3.7  Study size        13

3.8  Quantitative variables       14

3.9  Participant recruitment       15

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3.10  Participant characteristics      17

3.11 Main results        00 

4. ANALYSIS         15 

5. DISCUSSION                      20 

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6. REFERENCES         22

Introduction

Tobacco products are one of the most common causes of preventable diseases globally.(1) Their use leads to many diseases of the heart and lungs, these include but are not limited to chronic obstructive pulmonary disease (COPD), stroke and lung cancer. (2) Maternal use of these products puts the fetus at increased risk of a number of adverse health outcomes such as low birth weight, congenital disorders, and stillbirth being reported from studies.(3) With these being preventable diseases and malformations it may motivate one to quit or use a cessation technique in order to improve their own health or put their fetus at less of risk during its development.(4, 5)

Even with all the health risks of smoking being known it still remains a major public health issue with ~20% of pregnant women in Ireland reporting to have smoked during their pregnancy.(6) Prenatal smoking and the use of smokeless tobacco use can have a negative effect on the fetus birth weight. From a study of 34,928 singleton births, it has been reported that smoking can cause a reduction of 129g (95% CI -170, -87) in birth weight among normal weight women.(7) Maternal smokeless tobacco use has also been examined by the WHO and in a report in 2003 of smokeless tobacco use in India, it stated that there was 2-3 times higher rate of stillbirth and 2-3 times higher rate of low birth weight compared to that of non-exposed to smokeless tobacco. (8)

Currently, there are several cessation techniques available – quitting altogether, behavioral therapy, use of nicotine replacement therapy (NRT), medication and combination therapy.(9) Pharmaceutical intervention through the use of NRT and medications such as varenicline and bupropion have been reported as more effective methods of cessation than placebo for quitting.(10) However, the use of NRT and these medications in pregnancy are not without risk.

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With the use of NRT in pregnancy the fetus is exposed to nicotine and this can have an influence on brain development and may cause fetal harm.(11) From a Danish National Birth Cohort from 1997-2003, there was a suggested increase of congenital malformations risk with a relative prevalence rate ratio of 1.61 (95% CI, 1.01-2.58) in nonsmokers using nicotine substances compared to non-exposed children. Within this cohort, it was suggested that maternal use of NRT does not seriously affect birth weight, but there could be a negative effect on birth weight with the simultaneous use of more than one type of NRT product.(12) This posed the question that if there are high levels of maternal nicotine exposure is there an association with birth weight. The use of transdermal systems has appeared to show more positive results than chewing gum for cessation. However, there are concerns that transdermal patches can actually deliver more nicotine to the embryo/fetus as there are continuous blood levels of nicotine relative to episodic smoking or use of gums are available to cross the placenta. (13, 14)

According to Briggs’s Drug in Pregnancy and Lactation, there have been no reports describing the use of Varenicline in pregnancy and the benefit appears to outweigh the risk to the embryo and/or fetus. (15) However, there has been lack of studies in this area. The use of Bupropion has been suggested as low risk according to animal and human data. However, there has been a strong association between the use of Bupropion in pregnancy and attention-deficit/hyperactivity disorder (ADHD) in offspring, however, it was considered that cigarette smoking was a potential confounder. (16) It has been reported that there has been an increased rate of heart defects reported in two studies, however, this outcome has not been confirmed by other studies. (17, 18)

The use of electronic cigarettes has been proposed as an effective cessation technique for tobacco cigarette smokers. Electronic cigarettes are nicotine-delivery devices that vaporize a liquid also known as an e-liquid. This e-liquid contains nicotine that has been processed and purified from nicotine of tobacco leaves. This then is suspended within a mixture of glycerin or propylene glycerol with water and flavouring’s, and then vapourised. The nicotine is then inhaled into the respiratory tract and absorbed into the bloodstream.(19)

Electronic cigarettes and devices have now been showing an increase in use, especially among young people. There has been an 86% increase seen in users of electronic cigarettes or vaping devices from 2013 to 2015.(20, 21) Their use as a tobacco smoking cessation technique has been tested and was reported to have a potential for cessation, to have higher acceptability among smokers relative to NRT and seemed to have no greater risk of adverse effects.(22)

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However, there are concerns that electronic cigarette use may be a gateway product for nicotine containing products such as tobacco cigarettes. The influence of its use in the younger generations is a worry of health institutions around the globe. Approaches of these companies to advertise their product to the masses has been observed through TV advertising, celebrity endorsement, and music festivals. There is worry that these companies are portraying claims that electronic cigarettes are safe and beneficial despite them containing nicotine and other unknown containing excipients.(23)

The World Health Organization (WHO) also has expressed their concern about the safety of electronic cigarettes. Especially as it contains nicotine and this can have an adverse effect especially during pregnancy and can contribute to cardiovascular disease. Another worry is that from chronic inhalation of toxicants in the vapour to the user could lead to potential cytotoxicity have raised concerns about pregnant women who use electronic cigarettes or are exposed to them.(24) Another worry of the WHO is that the impacts of tobacco-controlled efforts are diminished due to the rapid growth of electronic cigarette use and advertisement. (24)

Electronic cigarette vapour has been found to have some toxic substances however relative to tobacco cigarettes they are lower.(20) The idea of substituting tobacco products with e-cigarettes may substantially reduce exposure to selected tobacco-specific toxicants, however this proposal warrants further study due to the differences in toxins inhaled.(25) With nicotine being observed to be a teratogen when used in pregnancy it is uncertain if delivery through electronic cigarettes will cause a low birth weight, have an influence on gestation, birth defects, stillbirth or premature birth.(26)

From a systematic review on the health effects of electronic cigarettes it was concluded that with many methodological problems, conflicts of interest, very few studies, inconsistencies and contradictions in results, there is no conclusive information that can be collected from studies of electronic cigarettes so far.(27) Lack of regulation and control of studies is an identified issue. With major tobacco companies such as British American Tobacco developing electronic cigarettes and carrying out their own studies give rise to the suspicion of these claims.(28) The World Health Organization’s stance on electronic cigarette use is uncertain as they state that “it is important to identify public health concerns and to consider these concerns when undertaking regulation and surveillance” and that “establishing a scientific basis on which to judge the effects of their use, and for ensuring that adequate research is conducted”.(24) Currently, there are no reported cohort studies conducted on electronic cigarette use in pregnancy.

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This prospective cohort protocol aims to explore the perinatal outcomes of electronic cigarette use during pregnancy compared to no exposure. Primarily focusing on examining its use and its association with birth weight. Secondary outcomes of gestational age, birth length, stillbirth, congenital disorders and premature births will also be examined.

Study Aim

The study will follow the PECO format (population, exposure, comparison, and outcome). The population of the study will be pregnant women who are users of electronic cigarettes. The full list of inclusion and exclusion criteria with included rationale can be seen in table 1 and table 2. This population will be recruited from the antenatal clinic of 2 large maternity hospitals (hospital A and hospital B) in Dublin Ireland. Mothers who are users of electronic cigarettes will be recruited over 34 weeks and information regarding their newborn infant will be collected through a questionnaire given by the attending midwife or personnel.

The exposure will be any first-hand electronic cigarette use by the mother during the gestational period. There will also be a recording of the amount of e-liquid consumed per week, brand and strength of e-liquid. This, in turn, will allow for determination of nicotine exposure per week through formulation. Electronic cigarette use will be self-reported by the mother and recorded by a trained midwife or personnel at their antenatal clinic visit.

The comparison will be women who give birth in selected hospital A or hospital B with a full history of antenatal clinic visit information. These women will be selected randomly on the fact that they were not exposed to nicotine-containing products during their pregnancy. A full list of inclusion and exclusion criteria and rationale can be seen in table 3 and table 4. These women will be selected on the factors of the exposed group maternal age at delivery, nulliparous and region of descendants in order to reduce the chance on confounding.

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This cohort protocol will be conducted in order to examine the use of electronic cigarettes in pregnancy and its association with birth weight. Other information regarding fetus gestation time, premature birth, stillbirth, and congenital disorders will also be recorded. Descriptive statistics will be applied to describe both groups. Binomial outcomes will be expressed as an odds ratio. Data will be presented in both adjusted and unadjusted formats. Data will be adjusted for maternal age at delivery, nulliparous and region of descendants. Collected information will also be graphed with birth gestation against birth weight for both the exposed values and non-exposed values will be done. A distribution graph of exposed and unexposed will also be created.

 Methods

The study will be carried out with pregnant women within antenatal clinics of two large maternity hospitals (hospital A & hospital B) in Dublin, Ireland that roughly 20,000 births per year occur in total. Midwives and personnel will be trained over 12 weeks on how to carry out the study. Participants (pregnant women who are users of electronic cigarettes) will be recruited over 34 weeks with a 10-week contingency period. After consent has been granted a midwife will question the participants with regards to their electronic cigarette use along with their routine obstetrician questions three times over 36 weeks of their gestation. The data will be stored in the participant’s antenatal file. Firstly upon their visit at less than 12 weeks gestation, followed up by their routine antenatal clinic visits at week 28 and at week 36. There will be a follow-up period of 36 weeks at the last day of recruitment for completion of all pregnancies. With recruitment starting when a mother indicates she is pregnant at the antenatal clinic (estimated 5-12 weeks gestation) along with a 36-week birth period this will allow for 41-48 weeks gestation. This will ensure all pregnancies will be completed by the end of the 36 weeks. Records of the infant’s birth details will be gathered and recorded at the end of the birth period by a representative of the study. An appropriate comparison of non-exposed will be recruited from electronic records of hospital A and hospital B and selected randomly by a representative following inclusion and exclusion criteria seen in table 3 and table 4. The total time for training and the study to be carried out is predicted to be 92 weeks. Data collection, selection of unexposed comparison from electronic records, sorting of data, and analysis of data is estimated to take 13 weeks The total estimated time is 105 weeks.

Figure 1: Gantt chart of study period.

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Table 1: Inclusion criteria for exposed group (users of electronic cigarettes).

Table 2: Exclusion criteria for exposed group (users of electronic cigarettes).

Of these women eligible for the study, the midwife will carry out an interview at their first antenatal clinic visit at <12 weeks gestation. The study will be discussed and the requirements for participation will be explained. Women will be given a participant information leaflet (see Appendix 1.A) and those who agree to participate will give written consent (see Appendix 1.B).(33)

The women who qualify for the study will then be asked a series of questions following their routine antenatal clinic questions with regards to their electronic cigarette use.

1. Average e-liquid consumption (in ml) per week
2. Brand of e-liquid used
3. Strength of e-liquid used (in mg/ml)

Then in order to classify nicotine exposure from electronic cigarettes, the following formula will be used.

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E Liquid consumption per week in ml × E Liquid strength inmgml=Average amount of nicotine inhaled in mg per week

Upon the subsequent visits at week 28 and week 36 thereafter, women will be asked the questions again with regards to their use since the last visit. Their average weekly electronic cigarette use will be calculated as an average over the entire pregnancy. This will be recorded as a continuous variable and then sorted categorically upon statistical analysis upon completion of the study. The mothers will be grouped indicating nicotine exposure from electronic cigarettes with regards to self-reported use (low: 0-14.99mg/week, medium: 15-134.99mg/week and high:

≥135mg/week). Both the continuous and categorical data will be analyzed through statistical methods.

The control group will be selected from the electronic booking delivery records of hospital A and hospital B. Of these records, women will be selected as a comparison based on certain maternal factors of maternal age at delivery, nulliparous and region of descendants in order to minimize the risk of selection bias.

Table 3: Inclusion criteria for non-exposed group (non-users of electronic cigarettes).

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Table 4: Exclusion criteria for non-exposed group (non-users of electronic cigarettes).

The primary outcome that will be measured will be birth weight in grams. Secondary outcomes will be the gestational time in weeks, premature birth, the occurrence of a stillbirth and any congenital defects present.

Birth weight will be recorded on a previously calibrated weighing scale to the nearest gram. The attending midwife or obstetrician will determine birth gestation time and classification of malformation.

Table 5: Other potential confounders that will be analyzed.