U.S. flag

An official website of the United States government

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

WHO Recommendations for the Prevention and Management of Tobacco Use and Second-Hand Smoke Exposure in Pregnancy. Geneva: World Health Organization; 2013.

Cover of WHO Recommendations for the Prevention and Management of Tobacco Use and Second-Hand Smoke Exposure in Pregnancy

WHO Recommendations for the Prevention and Management of Tobacco Use and Second-Hand Smoke Exposure in Pregnancy.

Show details

Recommendations

To assist in the formulation of the recommendations, the GDG outlined a number of overarching principles that it agreed should underpin all recommendations for optimal identification and management of tobacco use by and SHS exposure in pregnant women. These principles are based on the human rights and ethics values, outlined in the WHO FCTC (24), Convention on the Elimination of All Forms of Discrimination against Women (CEDAW) (34), and the Programme of Action of the International Conference on Population and Development (ICPD) (35). These principles, together with the implementation strategies and indicators for monitoring and evaluation presented later in the document, should guide stakeholders and policy-makers in the process of planning, implementing and evaluating the most suitable and relevant recommendation for their own circumstances.

It is necessary to note that all population-level policies and interventions for comprehensive tobacco control that are proven to be effective for the general population, would also help protect the health of pregnant women as well. These policies create an enabling environment which is promotive of non-use of tobacco, and enable and empower women to be able to implement their own choices.

OVERARCHING PRINCIPLES

It is a basic right of every pregnant woman to be informed about the harms of tobacco use in any form, as well as the harms of SHS exposure.

Every pregnant woman has the right to a smoke-free environment at the home, and at work and in public places.

All interventions addressing the prevention of tobacco use and SHS exposure in pregnancy should be:

  • woman-centred and gender-sensitive;
  • culturally appropriate and socially acceptable; and
  • delivered in a non-judgemental and non-stigmatizing manner.

Health centres, hospitals and clinics need to ‘practice what their providers preach’ by providing tobacco-free health-care facilities, and having the health-care providers as ‘tobacco-free role models’.

The presented recommendations are consistent with the guiding principles set out in the WHO FCTC (24).

This section includes nine recommendations for the prevention and management of tobacco use and SHS exposure in pregnancy. Each recommendation is followed by specific remarks related to that recommendation, which are intended to explain the context in which these recommendations were made. Narrative summaries of evidence supporting the recommendations are also included below each recommendation. (The decision tables summarizing the values, preferences and judgements made about the strength of the recommendations are available in Annex 7.)

IDENTIFICATION OF TOBACCO USE AND SECOND-HAND SMOKE EXPOSURE

RECOMMENDATION 1. Assessment of tobacco use and second-hand smoke exposure in pregnancy

Health-care providers should ask all pregnant women about their tobacco use (past and present) and exposure to SHS as early as possible in the pregnancy and at every antenatal care visit.

Strength of recommendation: Strong. Quality of evidence: Low

REMARKS

Tobacco use includes all forms of smoking and use of smokeless tobacco.

Second-hand smoke exposure includes exposure to smoke from combustible tobacco products at home, work and in public places.

Tobacco use (smoking and smokeless) status of husbands/partners and other household members should also be assessed.

At the first prenatal visit, health-care providers should ask all pregnant women about their tobacco use (past and present). Pregnant women with prior history of tobacco use should be asked about their present tobacco use at every antenatal care visit. Providers should ask women about their SHS exposure at the first prenatal visit, and whenever there is a change in living or work status and when SHS intervention has been initiated.

Before assessment is initiated in a clinic setting:

  • training and resource materials should be provided to clinicians and other health-care workers to enable effective and non-judgemental assessment of tobacco use; and
  • clinicians and other health-care workers should be trained to refer or intervene with all pregnant women who are identified as tobacco users (past and present) or exposed to SHS.

EVIDENCE FOR RECOMMENDATION 1

Overall question: What are the necessary elements for effective screening of pregnant women for smoking and smokeless tobacco use?

The first step in treating tobacco use and dependence is to identify tobacco users. Identification of smokers increases rates of clinician intervention. Effective identification of tobacco-use status not only opens the door for successful interventions (e.g. clinician advice and treatment), but also guides clinicians to identify appropriate interventions based on the tobacco-use status of patients and their willingness to quit.

PICO (Population, Intervention, Comparison, and Outcome) question used to examine evidence

PopulationPregnant women (all trimesters and postpartum)
InterventionActive screening for current and past tobacco use (frequency of use of smoked and smokeless tobacco; quantities of smoked and smokeless tobacco consumed), assessment of tobacco dependence, screening for SHS exposure
ComparisonTreatment as usual
Outcomes
  • Identification of current tobacco-use status
  • Identification of recent or past tobacco-use status
  • Identification of nicotine dependence
  • Identification of exposure to SHS

SYSTEMATIC REVIEWS AND OTHER SOURCES (E.G. QUALITATIVE STUDIES, COST-EFFECTIVENESS ANALYSES) IDENTIFIED BY THE SEARCH PROCESS

Although the search for evidence did not identify any relevant recent systematic reviews on screening pregnant women for tobacco use or SHS exposure, previous research has indicated efficacy of screening in a general health-care setting on successful cessation efforts (or intent) (36). WHO has developed the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), an instrument to detect and manage substance use and related problems in primary and general medical care settings. This instrument provides some information on how to assess tobacco use and provide brief intervention, but does not include any recommended action for the management of smokeless tobacco use or SHS exposure (37). The current recommendations have used guidance from various national guidelines as well as resource documents from international agencies to develop the narrative synthesis.

  • Methods for evaluating tobacco control policies. IARC Handbook of Cancer Prevention (Volume 12), 2008 (38).
  • Treating tobacco use and dependence: 2008 update. US Department of Health and Human Services, 2008 (36).
  • How to stop smoking in pregnancy and following childbirth. National Institute for Health and Clinical Excellence (NICE), the United Kingdom, 2010 (39).
  • Flemming H et al. (2012) Using qualitative research to inform interventions to reduce smoking in pregnancy in England: a systematic review of qualitative studies. The Journal of Advanced Nursing, 2010 (40).
  • The WHO ASSIST package: Manuals for the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) and the ASSIST-linked brief interventions, 2010 (37).
  • Gender, women, and the tobacco epidemic. WHO monograph, 2010 (41).
  • WHO guidelines for control and monitoring the tobacco epidemic. World Health Organization, 1998 (42).

NARRATIVE SYNTHESIS OF KEY FINDINGS

Tobacco use

The first step in effective intervention for tobacco cessation is assessment of tobacco-use status. The 2008 USA guidelines on ‘Treating tobacco use and dependence’, recommend that clinicians and health-care systems should use health-care visits for universal assessment and intervention for tobacco use (36). Specifically, it is recommended that every patient who presents to a health-care facility be asked if she/he uses tobacco. All patients should have their tobacco-use status documented on a regular basis. Evidence has shown that clinic screening systems, such as expanding the vital signs to include tobacco-use status or the use of other reminder systems such as chart stickers or computer prompts, significantly increase rates of intervention by health-care providers (36).

Studies have shown that not all health-care staff ask all pregnant women about their smoking status during consultations (39). There is evidence that health-care staff may not ask about smoking status fearing that doing so will negatively impact the relationship between themselves and their pregnant patients.

When asking about tobacco use, health-care staff should screen for current use as well as for past tobacco use, in order to identify pregnant women who may have quit recently (in the pre-conception period or early in the pregnancy) and are therefore vulnerable to relapse (36).

Research has shown that the use of multiple choice questions, as opposed to a simple yes/no question, can increase disclosure of tobacco use among pregnant women by as much as 40%. For example, giving women the opportunity to answer, ‘I am still smoking but I have cut down on my use’ or a similar response when asked about their tobacco-use status provides women with an opportunity to disclose that they are smoking while also showing they have taken steps to reduce exposure (36). It is important to communicate with the pregnant women in a sensitive, client-centred manner, particularly as some pregnant women find it difficult to say that they smoke. Such an approach is important in reducing the likelihood that pregnant women will conceal their tobacco use and thus miss out on the opportunity to get help (39).

Nicotine dependence

Nicotine dependence is a chronic disease that often requires repeated intervention and multiple attempts to quit (36). Nicotine is the drug in tobacco products that causes dependence. Nicotine dependence among adult smokers is characterized by the emergence of withdrawal symptoms in response to abstinence and by unsuccessful attempts to reduce the use of tobacco or to quit altogether. This dependence is not limited to smoked tobacco products: use of smokeless tobacco also results in nicotine dependence. The IARC handbook of cancer prevention on ‘Methods for Evaluating Tobacco Control Policies’ provides a list of instruments which could be used in different settings to assess tobacco dependence for various tobacco products (38).

Second-hand smoke exposure

The United Kingdom's guidance on ‘Quitting smoking in pregnancy and following childbirth’ recommends that during the first face-to-face antenatal care visit, health-care staff enquire if anyone else in the household smokes. This includes the woman's husband or partner if applicable (39). This is intended to determine both support for cessation, as well as an assessment of SHS exposure from other family members.

Frequency of assessment for tobacco use and SHS exposure

Although quitting early in pregnancy and remaining abstinent through the pregnancy will produce the greatest benefits to the fetus and expectant mother, even quitting at a late stage during pregnancy can yield benefits (36). Hence, the tobacco control programmes should strive to reach pregnant smokers as early as possible in the pregnancy and follow them throughout the pregnancy, and early postpartum to promote and support sustained smoking cessation (41). There is evidence that many women under-report smoking in pregnancy due to a strong stigma against smoking (36, 39, 43). During the multiple interactions with the health-care providers, women may become sufficiently comfortable to disclose their tobacco-use status. Therefore, it is important that clinicians assess tobacco-use status of pregnant women not only at the first prenatal visit, but also throughout the course of pregnancy as indicated.

Health-care workers should assess SHS exposure at the first prenatal visit as well as throughout the course of pregnancy, as circumstances may change at home or in the workplace (e.g. the arrival of a relative who smokes indoors, career moves, etc.).

The USA guidelines also advise that once a tobacco user is identified, the clinician should assess the patient's willingness to quit at this time (36). The patient should be asked, ‘Are you willing to make a quit attempt at this time?’ Such an assessment (willing or unwilling) is a necessary first step in treatment. In addition, every patient should be assessed for social, physical or existing medical conditions that may affect the use of planned cessation treatments (36).

Grading of evidence: Evidence was graded as low due to indirectness.

STRENGTH OF THE RECOMMENDATION

The GDG reviewed the above evidence and considered the harms, benefits, values, preferences, feasibility and cost-effectiveness of the proposed recommendation when drafting the recommendation. It was decided that the potential benefits strongly outweighed any harms, values were in support, and that it was cost effective and feasible in the antenatal care settings, and therefore should be classified as a strong recommendation. (See Annex 7 for detailed description of all issues considered in these domains.)

INTERVENTIONS FOR TOBACCO-USE CESSATION

RECOMMENDATION 2. Psychosocial interventions for tobacco-use cessation in pregnancy

Health-care providers should routinely offer advice and psychosocial interventions for tobacco cessation to all pregnant women, who are either current tobacco users or recent tobacco quitters.

Strength of recommendation: Strong. Quality of evidence: Moderate

REMARKS

Psychosocial interventions involve behavioural support that may include one or more of the following: counselling, health education, incentives and peer or social support.

Psychosocial interventions should be offered to pregnant women who are current or former tobacco users as early in pregnancy as possible.

The recommendation for recent tobacco quitters is based on population-based studies in non-pregnant populations. Recent tobacco quitters may include women who used tobacco before the pregnancy, and who have either spontaneously quit or stopped tobacco use in the pre-conception period or in early pregnancy, before their first antenatal visit.

There is emerging evidence from some countries that the use of financial incentives may be more effective than other interventions. However, it is difficult to generalize the reported effectiveness to the global population as the evidence is limited and is derived from select small populations.

The Stages of Change approach is not effective in pregnancy. The Stages of Change approach to tobacco cessation suggests that health behaviour change involves progress through six stages of change: pre-contemplation, contemplation, preparation, action, maintenance, and termination (44). As this approach is not effective, all women should be offered support irrespective of their intention to quit.

More heavily dependent tobacco users may require high intensity interventions.

Interventions should address concerns of the pregnant smokers about gaining weight as a result of tobacco cessation.

Interventions should recognize and address the impact of partner's smoking status and their attitudes towards tobacco use or cessation.

Recognizing that there is no safe level of tobacco use, there is evidence of some benefit from reduction in smoking if quitting is not achieved.

Almost all existing evidence for interventions is for smokers of manufactured cigarettes, but emerging evidence suggests that similar psychosocial strategies could be applied to users of other forms of tobacco (smokeless tobacco, waterpipes, etc.). There is limited evidence that stopping use of smokeless and other forms of tobacco may improve some birth outcomes.

Given the cost-effectiveness of these interventions, and long-term cost recovery to the health system through tobacco-related disease burden being averted, programme cost should not be a deterrent to immediate implementation.

EVIDENCE FOR RECOMMENDATION 2

Overall question: Is use of psychosocial interventions for tobacco dependence effective in pregnancy?

The complexity of smoking in pregnancy has generated many perspectives about the most appropriate approaches and strategies to support cessation.

PICO (Population, Intervention, Comparison, and Outcome) question used to examine evidence

PopulationPregnant women (all trimesters and postpartum) who use tobacco
InterventionPsychosocial interventions including counselling, health education, incentives, and peer or social support
ComparisonTreatment as usual
Outcomes
  • tobacco cessation in pregnancy
  • tobacco abstinence postpartum
  • smoking reduction from first antenatal visit to late pregnancy
  • maternal outcomes (mode of birth e.g. caesarean section rate)
  • fetal outcomes:
    –

    birth weight – mean birth weight, low birth weight (proportion less than 2500 g), very low birth weight (proportion less than 1500 g)

    –

    perinatal mortality (stillbirth, neonatal deaths, all perinatal deaths)

SYSTEMATIC REVIEWS AND OTHER SOURCES (E.G. QUALITATIVE STUDIES, COST-EFFECTIVENESS ANALYSES) IDENTIFIED BY THE SEARCH PROCESS

Cochrane systematic reviews of the range of interventions to support smoking cessation have been performed since 1995. The most recently published Cochrane review on this topic was carried out in 2009 (45). The 2009 review was then updated in 2012. The 2012 update was split into two separate reviews. Coleman et al. in 2012 evaluated pharmacotherapy to support smoking cessation (presented in a separate evidence profile on pharmacotherapy) (46), while Chamberlain et al. in 2012 evaluated the effectiveness of individual psychosocial interventions for supporting women to stop smoking in pregnancy and interventions to prevent smoking relapse among women who have spontaneously quit (47).

In addition to the Cochrane reviews, the following reviews were also used for the evidence retrieval and to inform the discussion on the values and preferences.

  • Baxter et al. Systematic review of how to stop smoking in pregnancy and following childbirth: review 2: factors aiding delivery of effective interventions (review prepared for NICE Public Health guidance 26), 2008 (48).
  • Taylor M. Economic analysis of interventions for smoking cessation aimed at pregnant women (paper prepared for NICE, the United Kingdom guidelines), 2009 (49).
  • Ebbert et al. Cochrane systematic review on interventions for smokeless tobacco-use cessation, 2011 (50).
  • Flemming H et al. Using qualitative research to inform interventions to reduce smoking in pregnancy in England: a systematic review of qualitative studies, 2012 (40).
  • Treating tobacco use and dependence: 2008 update. US Department of Health and Human Services, 2008 (36).

NARRATIVE SYNTHESIS OF KEY FINDINGS

A major limitation was the lack of studies conducted in low- to middle-income countries. Only 2 of 65 studies on psychosocial interventions during pregnancy were from low- or middle-income countries (Poland and four countries in South America). The criteria for ‘smoker’ varied, and only one study included women using smokeless tobacco products.

Many of the trials had multimodal interventions, but the main intervention strategies involved counselling (39 trials), health education (7 trials), feedback (7 trials), incentives (3 trials), and peer or social support (11 trials). Three trials offered optional nicotine replacement therapy as part of a multimodal intervention. Women in the control groups in 38 of the 67 trials received information about the risks of smoking in pregnancy and were advised to quit as part of ‘usual care’. The most frequent comparison was ‘usual care’ from a woman's antenatal care provider (30 trials).

Pooled data from 63 trials revealed that women receiving psychosocial interventions (counselling, health education, feedback, incentives, or peer or social support) were approximately 30% more likely to not smoke (i.e. be abstinent) late in pregnancy (RR=1.36, 95% confidence interval [CI] 1.22–1.52), compared to women in the comparison group (Number Needed to Benefit [NNTB]=25, 95% CI 17–40). This included both self-reported and biochemically validated smoking cessation. However, the heterogeneity was high (I2=58%).

The effect of the intervention on smoking in late pregnancy was still statistically significant among a subgroup of 17 trials with biochemically validated smoking cessation, assessed as ‘low risk of bias’ in this review (RR=1.43, 95% CI 1.13–1.80). It is unclear whether interventions to support women who spontaneously quit in early pregnancy reduce the rate of relapse in late pregnancy (RR=0.89, 95% CI 0.74–1.08). Although the effect on smoking in late pregnancy was still statistically significant among a subgroup of trials with ‘low risk of bias’, caution is urged in interpreting other results as potential sources of bias were identified and there is high heterogeneity. There was some weak evidence that women in intervention groups reduced smoking in late pregnancy, but the evidence was not consistent.

Among a subset of studies that examined cessation in the postpartum period, women receiving the psychosocial interventions were significantly more likely to remain abstinent in the early postpartum period (1–5 months) (RR=1.33, 95% CI 1.07–1.66), but this was not sustained in the longer term (6–12 months) (RR=1.10, 95% CI 0.83–1.44).

Interventions were grouped into five main intervention strategies: (i) counselling (n=38), (ii) health education (n=6), (iii) feedback (n=5), (iv) incentives (n=3), and (v) peer or social support (n=11). Interventions with incentives were the most effective (RR=2.86, 95% CI 2.25–3.46; n=3). This was followed by feedback (RR=2.26, 95% CI 1.77–2.75; n=5) and then counselling (RR=1.34, 05% CI 1.19–1.48; n=38). The pooled effect size estimates for social/peer support (RR=1.20, 95% CI 0.98–1.42; n=11) and health education (RR=1.14, 95% CI 0.69–1.59; n=6) were not statistically different.

Pooled data from 14 trials demonstrated that psychosocial interventions to support women to stop smoking in pregnancy reduce the rate of infants born low birth weight (<2500 g) (RR=0.83, 95% CI 0.71–0.97; NNTB=61, 95% CI 37–292) and preterm birth (<37 weeks) (RR=0.85, 95% CI 0.72–0.99; NNTB=97, 95% CI 53–1554). It is unclear whether interventions to stop smoking reduce: the rate of infants born very low birth weight (<1500 g); neonatal deaths; neonatal intensive care admissions or total perinatal mortality, as the outcome numbers were small. There were no differences reported in rates of caesarean section (two trials). One study examined maternal weight gain as an outcome, and found a mean excess weight of 2.8 kg among women who had stopped smoking compared to the women who did not quit.

The review defined intensity rating of interventions and controls as follows:

Low intensityProvision of leaflet, posters or self-help materials available AND advice to quit and written or verbal information on risks.
Medium intensityProvision of low intensity intervention AND self-help materials on strategies for quitting.
High intensityProvision of medium intensity intervention AND other forms of support, such as personal contacts, reminders, incentives, pharmacological agents.

Interventions categorized as ‘high intensity’, such as counselling (Pooled RR=1.36, 95% CI 1.20–1.54) are slightly more effective than those categorized as ‘low intensity’, such as provision of advice and self-help materials (Pooled RR=1.30, 95% CI 1.00–1.70), in supporting women to stop smoking. There was strong significant correlation between the intensity of both the intervention and control arms (i.e. higher intensity interventions were compared with higher intensity control conditions, and trials with lower intensity interventions were compared with lower intensity controls).

Newly included studies in this update of the review demonstrated a borderline effect of smoking cessation interventions in supporting pregnant women to stop smoking (RR=1.28, 95% CI 1.00–1.60), when compared to studies in the previous version of this review (RR=1.40, 95% CI 1.23–1.60) (45). The median intensity of ‘standard care’ provided in antenatal care in the comparison group has also increased over time, perhaps explaining attenuation of the association between the intervention and cessation.

There does not appear to be psychological harm caused by psychosocial interventions and two studies suggest some interventions may improve psychological well-being for women. Studies reporting women's views regarding the interventions (n=13) suggest personal contact may be important, though trials of emerging technologies, such as computer-based interventions and telephone support, have received positive feedback from women. In six studies looking at peer and partner support for smoking cessation, women reported mixed (both positive and negative) support experiences.

Studies reporting provider's views of the interventions suggest challenges to implementation in clinical settings, including competing demands on time and uncertainty over the effectiveness of interventions. These barriers may be overcome by including educational interventions directed at providers, use of referral services and technological aids.

Although psychosocial interventions administered in randomized controlled trials (RCTs) were effective (RR=1.37, 95% CI 1.22–1.54), the effect of interventions provided in cluster-randomized trials was smaller and not statistically significant (RR=1.23, 95% CI 0.84–1.78), suggesting challenges implementing research evidence into more general settings. However, the group noted that there were few cluster RCTs in general for smoking cessation in pregnancy and the data could be more robust if evidence from more RCTs was available.

Four studies conducted in high-income countries reported that the interventions were highly cost effective using a variety of measures. Pregnancy-specific self-help materials were more cost effective than standard smoking cessation information or self-help materials.

Tobacco control programme interventions should reach a pregnant smoker as early as possible in the pregnancy and follow her throughout the pregnancy and early postpartum to promote and support sustained smoking cessation (41).

Use of psychosocial interventions to support smokeless tobacco cessation in pregnant women

There have been no trials to study effect of psychosocial intervention in pregnant women using smokeless tobacco (ST). A 2011 Cochrane review of interventions for smokeless tobacco cessation identified 12 trials involving behavioural interventions in the adults, but these trials did not involve pregnant women (50). The results are as follows:

Behavioural interventions appear to be effective for increasing tobacco abstinence rates among smokeless tobacco users.

Behavioural interventions which include telephone support or an oral examination with feedback may be effective for increasing tobacco abstinence rates among smokeless tobacco users. These estimates combine both population-based interventions and individuals self-selecting for treatment.

The 2008 USA guidelines on ‘Treating tobacco use and dependence’ also recommend that smokeless tobacco users should be identified, strongly urged to quit, and provided counselling cessation interventions.

Grading of evidence: The quality of the evidence in Chamberlain et al. was graded as moderate quality for all outcomes. (See Annex 6 for GRADE tables.)

STRENGTH OF THE RECOMMENDATION

The GDG reviewed the above evidence and considered the harms, benefits, values, preferences, feasibility and cost-effectiveness of the proposed recommendation when drafting the recommendation. It was decided that the benefits strongly outweighed any harms, values were in support, and that it was cost-effective and feasible, and therefore should be classified as a strong recommendation. (See Annex 7 for detailed description of all issues considered in these domains)

RECOMMENDATIONS 3–5. Use of pharmacotherapy for tobacco-use cessation in pregnancy

The panel cannot make a recommendation on use or non-use of nicotine replacement therapy (NRT) to support cessation of tobacco use in pregnancy.

Strength of recommendation: Not applicable. Quality of evidence: Moderate

The panel does not recommend use of bupropion or varenicline to support cessation of tobacco use in pregnancy.

Strength of recommendation: Strong. Quality of evidence: No evidence available

The panel recommends that further research be carried out in pregnant women on safety, efficacy and factors affecting adherence to pharmacotherapeutic agents for tobacco-use cessation.

Strength of recommendation: Strong. Quality of evidence: Not applicable

REMARKS

The evidence search found no quality evidence on the use of pharmacotherapy with bupropion or varenicline for tobacco-use cessation in pregnancy.

There is currently insufficient evidence to determine whether or not pharmacotherapy (NRT, bupropion, varenicline) is effective when used in pregnancy for tobacco-use cessation.

There is currently insufficient evidence to determine whether or not pharmacotherapy (NRT, bupropion, varenicline) is safe when used in pregnancy for tobacco-use cessation.

Given the known considerable harms caused by tobacco smoking in pregnancy and the known benefits of using NRT from studies in the general population, it is acknowledged that various national guidelines have recommended use of NRT in pregnancy under medical supervision.

Urgently needed research includes: studies of factors improving or impeding adherence to pharmacotherapeutic agents; a review of the effects (safety profiles, effectiveness) of use of NRT in pregnant women, particularly in the United Kingdom where a historical cohort exists for use of NRT in pregnancy; use of client preference trials (client's preference of pharmacotherapy treatment versus no treatment); and surveillance of current use of pharmacotherapy in pregnancy (focused on determining whether women use pharmacotherapy when recommended or prescribed by health-care providers).

EVIDENCE FOR RECOMMENDATIONS 3–5

Overall question: Is use of pharmacological treatment for tobacco dependence safe and effective in pregnancy?

Three first-line pharmacological agents were approved by the United States Food and Drug Administration (FDA) to treat tobacco-use dependence (36). The following agents have been found to be safe and effective in assisting with tobacco cessation (smoking and smokeless tobacco) in the general population:

  1. Nicotine replacement therapy (NRT) in several forms (patches, gum, nasal sprays, oral sprays, inhalers, microtabs and lozenges)
  2. Bupropion
  3. Varenicline

PICO (Population, Intervention, Comparison, and Outcome) question used to examine evidence

PopulationPregnant women (all trimesters and postpartum who are dependent on tobacco)
InterventionNicotine replacement therapy, bupropion, varenicline
ComparisonTreatment as usual
Outcomes
  • Adherence to or compliance with treatment
  • Efficacy: tobacco-use cessation
  • Safety: maternal outcomes (e.g. preterm birth, caesarean section rate and fetal outcomes (e.g. miscarriage/spontaneous abortion, stillbirth, congenital abnormalities, any effects of fetal growth, neonatal intensive care admissions.)

SYSTEMATIC REVIEWS AND OTHER SOURCES (E.G. QUALITATIVE STUDIES, COST-EFFECTIVENESS ANALYSES) IDENTIFIED BY THE SEARCH PROCESS

The evidence search found randomized controlled trials and observational studies on the use of NRT in pregnancy, one observational study on use of bupropion in pregnancy and none for varenicline. The latter two medications are not recommended for use in pregnancy in most countries (36, 39).

Nicotine replacement therapy is available as patches, gum, nasal sprays, inhalers, and lozenges; all have been used to treat tobacco dependence in pregnancy. Concerns about fetal safety and possible adverse maternal outcomes have led to limitations on its use in pregnancy in many countries. National and professional guidelines from Canada and the United Kingdom recommend use of NRT in pregnancy only when psychosocial interventions fail (39, 51). Randomized controlled trials of NRT have been performed, all of them in high-income countries, measuring continuous smoking abstinence or point prevalence of smoking abstinence and comparing adverse effects – maternal and fetal – between the intervention and control groups.

The following Cochrane and other systematic reviews were used for evidence retrieval.

  • Coleman et al. Pharmacological interventions for promoting smoking cessation in pregnancy, 2012 (46).
  • Myung et al. Efficacy and safety of pharmacotherapy for smoking cessation among pregnant smokers: a meta-analysis, 2010 (52).
  • Taylor M. Economic analysis of interventions for smoking cessation aimed at pregnant women (paper prepared for NICE Public Health guidance 26), 2009 (49).
  • Baxter et al. Systematic review of how to stop smoking in pregnancy and following childbirth: review 2: factors aiding delivery of effective interventions (review prepared for NICE Public Health guidance 26), 2008 (48).
  • Ebbert et al. Cochrane systematic review on interventions for smokeless tobacco-use cessation in general population, 2011 (50).
  • Inclusions: systematic reviews performed within the past two years.
  • Exclusions: Myung et al., 2012, was not used for grading of evidence on NRT because it gave a pooled effect using combined studies on NRT and one using bupropion. However, information on side effects and attitudes in this review was used to inform values and preferences domains for this recommendation.

NARRATIVE SYNTHESIS OF KEY FINDINGS

Use of NRT to support smoking cessation in pregnant women

Coleman et al. found that NRT had a small (RR=1.3, 95% CI 0.93–1.91) but non-significant effect on smoking cessation (46). There were non-significant increases in rates of stillbirth, miscarriage and birth by caesarean section, and non-significant reductions in preterm births, neonatal intensive care admissions and neonatal deaths. Adherence to recommended treatment was generally low in the included studies. Nicotine is metabolized faster in pregnant women than in non-pregnant women. This means that pregnant women are likely to need higher doses of NRT as compared to non-pregnant women to substitute for nicotine received from tobacco. Subsequently a higher dose of NRT may be needed for cessation. Many of the studies in the Coleman review used the standard NRT dose (principally 15 mg, delivered via a 16-hour patch). This, together with low adherence would lead to very low exposure to the intervention, which may explain the lack of observed effect.

Use of pharmacotherapy to support smokeless tobacco cessation in pregnant women

There have been no trials comparing pharmacotherapy to placebo in pregnant women using smokeless tobacco. A 2011 Cochrane review of interventions for smokeless tobacco cessation identified 11 trials comparing pharmacotherapy to a placebo in the adults but these trials did not involve pregnant women (50). The results are as follows:

Two small trials of bupropion did not detect an effect on smokeless tobacco abstinence, although the wide confidence intervals (OR=0.86, 95% CI 0.47–1.57) do not rule out a small benefit.

Four trials of nicotine patch did not detect a benefit (OR=1.16, 95% CI 0.88–1.54), nor did two trials of nicotine gum (OR=0.98, 95% CI 0.59–1.63).

Data from one study among Swedish snus users suggests that varenicline can increase tobacco abstinence rates at six months (OR=1.6, 95% CI 1.08–2.36).

Grading of evidence: The quality of the evidence in Coleman et al. was graded as moderate. (See Annex 6 for GRADE tables.)

STRENGTH OF THE RECOMMENDATION

The GDG reviewed the above evidence and considered the harms, benefits, values, preferences, feasibility and cost-effectiveness of the proposed recommendation during the recommendation drafting process. Given that there was good quality but inconclusive evidence on both the effectiveness and impact on fetal outcomes for NRT, and acknowledging that in some countries NRT is recommended for smoking cessation in pregnant women when behavioural therapy fails, the panel decided they could not make a specific recommendation on the use or non-use of NRT. The group also noted that this is an area of great public health importance where presently there are large gaps in research and evidence, and made a strong recommendation for further research to be carried out on safety, efficacy and factors affecting adherence to pharmacotherapeutic agents in pregnant women for tobacco-use cessation. (See Annex 7 for a detailed description of all issues considered in these domains.)

PROTECTION FROM SECOND-HAND SMOKE

RECOMMENDATIONS 6–7. Protection from second-hand smoke in pregnancy (smoke-free public places)

All health-care facilities should be smoke-free to protect the health of all staff, patients and visitors including pregnant women.

Strength of recommendation: Strong. Quality of evidence: Low

All work and public places should be smoke-free for the protection of everyone including pregnant women.

Strength of recommendation: Strong. Quality of evidence: Low

REMARKS

Health-facility staff who use tobacco should be offered cessation services.

EVIDENCE FOR RECOMMENDATIONS 6–7

Overall question: What are the effective interventions to prevent SHS exposure to pregnant women at health-care facilities, workplaces and other public places?

Article 8 of the WHO Framework Convention for Tobacco Control (WHO FCTC) on protection from exposure to tobacco smoke obliges WHO Member States who have ratified the treaty (176 parties as of 23 August 2012) to protect all people from exposure to SHS in indoor workplaces, public transport and indoor public places. As a result, many countries around the world have banned smoking in public places (24). At its second session in July 2007, the Conference of the Parties (COP) adopted guidelines for implementation of Article 8 of the WHO FCTC on protection from exposure to SHS (53).

Many countries, regardless of their FCTC ratification status, are taking steps to protect their citizens from the harms of SHS in public places, through either planning the steps or implementing national smoke-free laws for public places or workplaces. As of December 2010, more than 739 million people globally were protected by comprehensive, national smoke-free laws. However, 107 countries spanning all levels of economic development still have the lowest level of legal protection, i.e. no smoke-free policies in place at all, or policies that cover only one or two of the eight types of public places assessed (16). Furthermore, in many countries smoke-free laws are not fully enforced, leading to variable compliance of the public with the legislation.

Status of smoke-free policies for public places in WHO Member States as of 2011*

Type of public placeNo. of countries
Health-care facilities52
Educational facilities excluding universities50
Universities42
Government facilities37
Indoor offices24
Restaurants21
Pubs and bars18
Public transport41
*

A country may have more than one type of ban.

PICO (Population, Intervention, Comparison, and Outcome) question used to examine evidence

PopulationPregnant women (all trimesters and postpartum) who are exposed to tobacco smoke) visiting public places (including work areas, health-care facilities, restaurants, public transport, educational institutes etc.)
InterventionCommunity and population-based interventions to reduce exposure to SHS (smoke-free legislation)
ComparisonNo community or population-based intervention to reduce exposure to SHS
Outcomes
  • Reduced exposure of pregnant women to SHS at health-care facilities, workplaces, and public places
  • Reduced smoking prevalence among pregnant women
  • Reduction in adverse birth outcomes related to SHS exposure of pregnant women to SHS at health-care facilities, workplaces, and public places

SYSTEMATIC REVIEWS AND OTHER SOURCES (E.G. QUALITATIVE STUDIES, COST-EFFECTIVENESS ANALYSES) IDENTIFIED BY THE SEARCH PROCESS

No recent systematic reviews were identified that were specific to the impact of the smoke-free policies on SHS exposure in pregnant women. However, there is strong evidence to support smoke-free policies to protect the general population from SHS; in turn these policies will also benefit the subpopulation of pregnant women.

The following systematic reviews and peer-review publications were used to develop the narrative synthesis.

  • Callinan et al. Legislative smoking bans for reducing SHS exposure, smoking prevalence and tobacco consumption. Cochrane Database of Systematic Reviews, 2010 (54).
  • Charrier et al. Smoking habits in Italian pregnant women: any changes after the ban? 2010 (55).
  • Puig et al. Assessment of prenatal exposure to tobacco smoke by cotinine in cord blood for the evaluation of smoking control policies in Spain, 2012 (56).
  • Mackay et al. Impact of Scotland's smoke-free legislation on pregnancy complications: retrospective cohort study, 2012 (57).
  • Adams et al. Reducing prenatal smoking: the role of state policies, 2012 (58).

NARRATIVE SYNTHESIS OF KEY FINDINGS

There has been an increase in the number of countries implementing national and subnational policies which ban or restrict smoking in public places and workplaces. The main reason for these policies is to protect non-smokers from the harmful health effects of exposure to SHS (54). Smoke-free environments also help smokers who want to quit, and bans on smoking in public places and workplaces may also encourage people to make their homes smoke-free to protect the non-smokers (59).

Impact of smoke-free policies on SHS exposure

General population: A 2010 Cochrane review looking at the impact of smoke-free policies on exposure to SHS in the general population found that smoking bans reduced exposure to SHS in workplaces, restaurants, pubs and in public places. Hospitality workers experienced a greater reduction in exposure to SHS after implementing the ban as compared to the general population. There was no change in exposure to SHS in private cars. In general, there was no change in the levels of SHS exposure at home after the implementation of the smoking bans across all studies, though some studies reported reductions in exposure to SHS at home after public smoking bans were implemented (54). Following the implementation of legislation in Scotland prohibiting smoking in all partially or completely enclosed public spaces in 2006, many studies have shown a reduction in smoking and in SHS exposure in adults and children (57).

Pregnant women: Italy introduced smoke-free legislation in 2005. A study looking at the impact of the ban on smoking in indoor public places on pregnant women in Italy, reported a marked drop in exposure to SHS in pregnant women in the workplace but not in the home (55). Spain introduced smoke-free legislation to reduce SHS in 2005. A cross-sectional survey assessed cotinine concentrations in infant cord blood in separate cohorts of mothers and newborns at three time points: 1996–98, 2002–04 (immediately before implementation in 2005), and 2008 (after implementation) of smoke-free workplace bans in Spain. In the 2008 cohort, the percentage of infants with no prenatal SHS exposure (cord blood cotinine 0.2–1 ng/mL) was 73.4%, compared to 56.9% in 2002–04, and 10.8% in 1996–98, showing that public smoking bans reduced prenatal SHS exposure (56).

Impact of smoke-free policies on smoking prevalence

General population: There is limited evidence regarding the impact of smoke-free legislation on reduction in active smoking (54).

Pregnant women: In Scotland, researchers found that following implementation of the smoking bans, rates of current smoking among pregnant women dropped significantly from 25.4% to 18.8% (57). Similar results were also observed in a study from the United States, in which pooled data from 225 445 women with live births during 2000–2005 in 29 states and New York City were analyzed. The researchers found that implementing a full private worksite smoking ban increased third trimester quit prevalence by five percentage points. This suggests that national and local tobacco control policies can effect an increase in smoking cessation in pregnant women (58).

Impact of smoke-free policies on health outcomes

General population: There is strong evidence to suggest that the health of those affected by the smoking ban improves as a result of implementation of the ban (54). A 2010 Institute of Medicine report concluded that smoking bans are effective in reducing the risk of coronary heart disease and heart attack (59). The implementation of smoke-free legislation in Scotland has been accompanied by significant reductions in the incidence of both cardiovascular and respiratory disease (57).

Pregnant women: Few studies have demonstrated improvement in birth outcomes following smoking bans. Following the introduction of national, comprehensive smoke-free legislation in Scotland, there was a significant drop in overall preterm births (-11.72%, 95% CI -15.87, -7.35, p<0.001), and spontaneous preterm labour (-11.35%, 95% CI -17.20, -5.09, p=0.001), which remained after adjustment for potential confounding factors. Likewise, there was a significant decrease in the number of infants born small for gestational age (24.52%, 95% CI 28.28, 20.60, p=0.024). These significant reductions occurred in both smoking and never-smoking mothers, suggesting that the introduction of smoking bans in Scotland was associated with significant reductions in preterm birth and babies being born small for gestational age (57).

Grading of evidence: Evidence was graded as low due to indirectness.

STRENGTH OF THE RECOMMENDATION

The GDG reviewed the above evidence and considered the harms, benefits, values, preferences, feasibility and cost-effectiveness of the proposed recommendation during the drafting process. It was decided that potential benefits strongly outweighed harms, values were in support, and that it was cost effective and feasible and therefore should be classified as a strong recommendation. (See Annex 7 for a detailed description of all issues considered in these domains.)

RECOMMENDATIONS 8–9: Protection from second-hand smoke in pregnancy (smoke-free homes)

Health-care providers should provide pregnant women, their partners and other household members with advice and information about the risks of SHS exposure as well as strategies to reduce SHS in the home.

Strength of recommendation: Strong. Quality of evidence: Low

Health-care providers should, wherever possible, engage directly with partners and other household members to inform them of the risks of SHS exposure to pregnant women and to promote reduction of exposure and offer smoking cessation support.

Strength of recommendation: Strong. Quality of evidence: Low

REMARKS

The overall goal of the intervention should be to eliminate SHS exposure at home.

Efforts to reduce SHS exposure can also help to reduce active tobacco use in pregnant women.

EVIDENCE FOR RECOMMENDATIONS 8–9

Overall question: What interventions are effective for reducing SHS exposure in the home?

PICO (Population, Intervention, Comparison, and Outcome) question used to examine evidence

PopulationPregnant women (all trimesters) exposed to SHS in their homes
InterventionInterventions to reduce SHS exposure at home (e.g. education and counselling to increase awareness in women of harms of exposure and means to minimize them, counselling of husbands, partners or other tobacco-smoking household members)
ComparisonUsual care, no intervention to reduce exposure
Outcomes
  • Reduced exposure of pregnant women to SHS at home
  • Quit rates in smoking partners

SYSTEMATIC REVIEWS AND OTHER SOURCES (E.G. QUALITATIVE STUDIES, COST-EFFECTIVENESS ANALYSES) IDENTIFIED BY THE SEARCH PROCESS

No recent systematic reviews of interventions to reduce the exposure of pregnant women to SHS at home were identified. Although the following two reviews focused on the reduction of SHS exposure of infants rather than pregnant women, these were used for evidence retrieval for interventions aimed at fathers or partners of pregnant women to make homes smoke-free.

  • Baxter et al. Which interventions are effective and cost-effective in encouraging the establishment of smoke-free homes? 2009 (48, 60).
  • Hemsing et al. Interventions to improve partner support and partner cessation in pregnancy, 2012 (61).

There is mixed evidence in regard to the effect of counselling plus other interventions (such as provision of written materials or telephone support) on making homes of pregnant women smoke-free. There was also mixed evidence from studies reporting on interventions based on the use of motivational interviewing of parents to promote smoke-free homes, and evaluations of individually adapted smoke-free home plans.

WHO commissioned a systematic review on ‘Interventions to reduce SHS exposure among non-smoking pregnant women’, which searched the Cochrane library and eight databases, yielding five studies (62). The results from this review are reported as a narrative synthesis below.

NARRATIVE SYNTHESIS OF KEY FINDINGS

Five studies were found that evaluated a clinical intervention to reduce SHS exposure among non-smoking pregnant women. One RCT conducted in the United States (Washington, DC) among non-smoking African-American pregnant women tested a behavioural intervention that included counselling, role play, skills practice and building negotiation skills with partners and household members who smoked (63). Pregnant women in the intervention group were less likely to report SHS exposure than women in the control group (OR=0.57, 95% CI 0.38–0.84). In an RCT conducted in Guangzhou, China, pregnant women in the intervention group received educational materials and brief advice (2–3 minutes) on the harms of SHS from their obstetrician (64). Husbands of women in the intervention group were more likely than those in the control group to not smoke in the previous seven days (8.4% versus 4.8%, p=0.04); however, no difference was found in reported not smoking in the previous 30 days (6.1% versus 4.2%, p=0.26). Another study conducted in Sichuan, China found that by providing educational materials on SHS as well as counselling by obstetricians, significantly decreased mean nicotine concentration in the hair of the mothers in the intervention compared to the controls (for intervention: 0.3 log micro g/g at follow-up compared to 0.5 at baseline; and for control: 0.5 log micro g/g at follow-up compared to 0.4 at baseline) (65).

In an RCT conducted in Isfahan, Iran, midwives were trained to provide 15–20 minutes of education during prenatal care visits on the harms of SHS exposure during prenatal care visits (66). The authors found that pregnant women's self-reported weekly SHS exposure was lower in the intervention group compared with the control group at each of the third, fourth, and fifth prenatal care sessions, p<0.001 (e.g. at the fifth visit, 12.3 versus 25.4 weekly mean number of cigarettes husband smoked near the woman). There was no difference between the two groups at the initial session. The fifth study in Brisbane, Australia, involved both counselling by a general practitioner and use of a nicotine patch to help partners of pregnant women to quit smoking (67). The authors found that 48 out of 291 men (16.5%) in the intervention group self-reported quitting compared to 25 out of 270 men (9.3%) in the control group (p=0.011, OR=0.52, 95% CI 0.31–0.86); biochemical verification (carbon monoxide testing) was carried out on a subsample of men who reported quitting.

Interventions

A small number of randomized controlled trials suggest that providing brief advice or counselling to non-smoking pregnant women may reduce SHS exposure; however, studies are needed with biochemical measures of SHS exposure.

Only one study has examined the effect of partner cessation in reducing SHS exposure among non-smoking pregnant women. Similar to other studies in the general population, this study found that counselling and use of a nicotine patch increased quitting among the partners or husbands of pregnant women.

Cost effectiveness: No evidence

Adverse outcomes: No evidence

Grading of evidence: The evidence has been graded as low indicating we are uncertain about the estimate of effect. (See annex 6 for GRADE tables.)

STRENGTH OF THE RECOMMENDATION

The GDG reviewed the above evidence and considered the harms, benefits, values, preferences, feasibility and cost-effectiveness of the proposed recommendation when drafting the recommendation. It was decided that the potential benefits strongly outweighed the harms, values were in support, and that it was feasible and therefore should be classified as a strong recommendation. (See Annex 7 for a detailed description of all issues considered in these domains.)

Copyright © World Health Organization 2013.

All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: tni.ohw@sredrokoob).

Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO web site (www.who.int/about/licensing/copyright_form/en/index.html).

Bookshelf ID: NBK190305
Contents

Views

In this Page

Other titles in this collection

Recent Activity

ClearTurn OffTurn On

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...