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Tobacco and nicotine use in pregnancy: Cessation strategies and treatment options

Tobacco and nicotine use in pregnancy: Cessation strategies and treatment options
Literature review current through: Jan 2024.
This topic last updated: Dec 15, 2023.

INTRODUCTION — Pregnancy is an optimal time for smoking cessation interventions because pregnant individuals are often highly motivated to stop smoking and have frequent and regular contact with clinicians, which provides multiple opportunities to assess and reinforce abstinence. Concerns over the dangers of cigarette smoking for the fetus serve as an additional motivator to stop smoking. Additionally, pregnancy also provides an opportunity to educate the patient's partner or family members on the benefits of smoking cessation for themselves, the patient, and the baby.

This topic will review strategies and treatment options for those who desire to stop smoking while pregnant. Related information on the impact of cigarette smoking on maternal and fetal outcomes is reviewed separately. (See "Cigarette and tobacco products in pregnancy: Impact on pregnancy and the neonate".)

In this topic, when discussing study results, we will use the terms "woman/en" or "patient(s)" as they are used in the studies presented. We encourage the reader to consider the specific counseling and treatment needs of transgender and gender diverse individuals.

EPIDEMIOLOGY OF SMOKING CESSATION — Survey and birth certificate data indicate that 35 to 75 percent of pregnant individuals who smoke completely stop smoking by the end of pregnancy [1-4]. Most individuals who quit smoking on their own during pregnancy do so prior to their first prenatal visit. In the absence of intervention, those still smoking after their first prenatal visit are likely to continue smoking during pregnancy. A study of US birth certificate data reported that the percentage of pregnant persons who smoked declined from 7.2 to 3.7 percent between 2016 and 2022 [5].

Risk factors for continued smoking include lower education status (high school level or less), heavy smoking (>10 cigarettes per day), a partner or other household member who smokes, public insurance, poor coping skills, multiparity, and coexisting emotional or psychiatric problems (eg, depression) [6-16]. Because many of these factors are interrelated, their independent effects are difficult to discern [17].

IMPACT OF HEALTH CARE PROVIDER INTERVENTION — There is expert consensus that pregnant persons who use tobacco should be identified early in pregnancy and provided augmented, pregnancy-tailored counseling on smoking cessation [18-21]. Examples of brief interventions include information about smoking-related risks from the physician and frequent follow-up to assess patient progress, as well as use of a pregnancy-specific or other self-help manual, one or more sessions with a health educator, and video tapes on smoking risks and cessation. Despite evidence that brief interventions work to reduce maternal smoking, it is estimated that only 49 percent of obstetricians routinely advise and provide follow-up for smoking cessation; furthermore, only 28 percent discuss actual strategies for cessation [8]. (See 'General questions (5 A's) to smoking cessation' below.)

Data from meta-analyses of randomized trials show that health care provider-initiated interventions can lead to significant reductions in the number of people smoking during pregnancy and improved birth outcomes [22-24]. As examples:

A 2017 meta-analysis of 16 trials, including over 6100 women, reported that smoking cessation interventions were associated with a reduced risk of low birth weight infants (odds ratio 0.65, 95% CI 0.42-0.88) [25].

A different 2017 meta-analysis comparing psychosocial interventions (eg, counseling, health education, feedback, incentives, social support) with usual care reported use of these interventions increased the proportion of women who stopped smoking in late pregnancy (average risk ratio 1.44, 95% CI 1.19-1.73, 30 trials) and reduced low birth weight infants by 17 percent [26].

In a 2014 systematic review, the Agency for Healthcare Research and Quality found that the difference in cessation rates between pregnant individuals who smokes who received an intervention and control groups ranged from 5.8 percent to 31.0 percent, although this did not lead to marked improvements in infant outcome [27].

APPROACH TO SMOKING CESSATION

Our approach — We refer all patients with a clear intention to quit smoking to cessation counseling. (See 'Behavioral counseling' below.)

Behavioral counseling – For individuals who do not smoke heavily, express that they can do this on their own, or for those who desire medication-free cessation, we recommend a trial of cessation counseling without pharmacotherapy to avoid any potential risks of pharmacotherapy. (See 'Behavioral counseling' below.)

Counseling plus pharmacotherapy – For individuals who do not feel they can stop on their own or who smoke heavily, we suggest pharmacotherapy as an adjunct to smoking cessation counseling. We discuss the risks and benefits of pharmacotherapy with either nicotine replacement therapy (NRT) or bupropion and ask about any contraindications. While both NRT and bupropion are reasonable drug options, the optimal treatment is not known, and the patient's preferences help determine the medication choice. (See 'Pharmacotherapy' below.)

For all patients, we also ask about additional comorbidities, such as anxiety, depression, or substance use, that may be contributing to continued smoking. We advise guided meditation (free via smartphone apps or online) and counseling with a mental health provider for all those who report anxiety. We refer patients as needed for treatment of depression or substance use disorder. We involve partners in the discussion as much as possible, and if they smoke, we discuss how smoking cessation can benefit them, their partner, and their family. If the partner is interested in quitting, we refer to the primary care physician for smoking cessation treatment.

General questions (5 A's) to smoking cessation — The five A's (ask, advise, assess, assist, and arrange) provide a general approach to helping patients stop smoking, as detailed in the table (table 1) [19,20,28-30]. The specific action steps outlined have been gathered from various investigators and guideline panels and are not exclusive to pregnant people.

Ask – Ask all patients (pregnant and nonpregnant) about and document smoking status (current and past) at every visit (including smoking status of household members) and whether anyone smokes in the woman's home or car. Among current patients who smoke, document number of cigarettes smoked per day [31-34]. For pregnant individuals, we counsel about the benefits of quitting, including the benefits that are specific to pregnancy. We encourage patients to quit smoking before planning a pregnancy and refer those who are interested in quitting to smoking cessation programs.

Remember that some patients find it difficult to admit to smoking initially or upon relapse. In one study of 107 self-reported pregnant quitters, 26 percent had salivary cotinine levels consistent with current smoking [35]. Questions that can help patients disclose their smoking status are listed in the table (table 1).

For patients who have stopped smoking, we congratulate them on what they have done to improve their health and that of their families. Recent quitters are at risk for relapse/continued smoking. Hence, we continue to ask about smoking status at each visit and continue to provide positive reinforcement.

For patients who report active smoking, we initiate or continue a strategy to help her quit.

Advise – Advise persons who smoke to stop smoking. Patients advised to quit rather than just cut down are more likely to stop smoking [19]. Advise patients that quitting at any point during pregnancy is beneficial, although quitting as soon as possible is the best. We discuss the benefits of smoking cessation for the pregnancy as well as for lifelong maternal and family health. We also discuss the known risks of continued smoking on pregnancy complications and risks to her child. We advise individuals who quit smoking during pregnancy to make a commitment to staying tobacco-free after delivery and include partners/other family members in the discussion whenever possible.

Assess – Assess the patient's readiness to quit smoking in the next month. Accept a patient's decision to continue to smoke nonjudgmentally and continue to follow-up and encourage/offer help for smoking cessation.

Assist the patient who wants to quit – Several approaches have been proposed, with minimal to good supporting evidence:

Connect the smoker to pregnancy-specific, structured smoking cessation support, which is available in a variety of formats that include written material, videos, computer websites, telephone calls or text messages, or in-person counseling in individual or group settings [36-39].

Offer a direct referral to a smoker's quit line to provide ongoing telephone counseling and support (eg, in the United States: 1-800-QUIT NOW and various local lines; in the United Kingdom: 0800-1699-169). Mobile phone messaging support can be helpful [40].

Refer to a smoking cessation counselor/health educator [36]. (See "Behavioral approaches to smoking cessation".)

Provide financial incentives, if available [41,42]. The odds of quitting with the use of incentives are three times the odds of quitting in the absence of incentives, holding all other interventions constant [27].

If she feels that she can quit, we congratulate her on wanting to quit, and at that moment, we set a quit date. We outline strategies to prepare for this date (eg, throw out ashtrays, inform other nonsmoking family members, and avoid scenarios associated with smoking).

Offer pharmacotherapy [23,43]. This strategy can be considered after counseling and behavioral support if patients find they are unable to quit on their own. Those who smoke heavily are less likely to quit on their own. (See 'Pharmacotherapy' below.)

Assist the patient who is NOT ready to quit now – (See "Behavioral approaches to smoking cessation", section on 'Patients not ready to quit'.)

Accept her decision nonjudgmentally. Address concerns related to quitting.

Explore and address barriers that prevent the woman from utilizing smoking cessation resources (eg, lack of knowledge, fear of failure or stigmatization, access and resource issues, partner issues, family or partner smoking, coexisting anxiety).

Support the importance of having smoke-free space at home. Encourage the patient to adopt a smoke-free policy for her home and car. Encourage household members who smoke to quit for their own benefit or at least refrain from smoking in the home or car. Both actions help the pregnant woman quit [44,45].

Recommend that she cut down the number of cigarettes. If she is willing to cut down, set a goal at the counseling visit for the number of cigarettes per day. Document this goal in your visit note so that it prompts you at the next visit to review with her. Provide positive reinforcement for cutting down. If she notes she was unable to reduce the number of cigarettes, explore and address barriers as above.

Refer for management of coexisting anxiety or depression, which may be affecting her ability to reduce or quit smoking.

Arrange – Address tobacco use at every subsequent prenatal visit to track progress, reinforce success, and provide ongoing assistance to individuals who continue to smoke. Lack of ongoing follow-up and support decrease the chance of successful smoking cessation.

This approach is similar to that used in nonpregnant adults and adolescents and reviewed in detail elsewhere in UpToDate:

(See "Overview of smoking cessation management in adults".)

(See "Benefits and consequences of smoking cessation".)

(See "Substance use disorders: Motivational interviewing".)

(See "Behavioral approaches to smoking cessation".)

(See "Pharmacotherapy for smoking cessation in adults".)

(See "Management of smoking and vaping cessation in adolescents".)

Barriers — Barriers to cessation, attitudes to nicotine patch use, and perceptions of cessation counseling among pregnant persons have been studied using focus groups [46]. Reasons given for continuing to smoke in pregnancy were skepticism about smoking-related harms, addiction to nicotine, and the smoking behavior of partners and/or family members. Most patients considered use of nicotine patches acceptable; however, some expressed doubt of patch safety, believing continued smoking was preferable. The patients noted that care providers differed in their approaches to smoking cessation and that some no longer asked about smoking status after they reported "cutting down."

Abstinence versus reduction — Although abstinence early in pregnancy will produce the greatest benefits to the fetus and mother, quitting at any point in pregnancy can yield benefits [30]. On the other hand, reduction in the number of cigarettes smoked during pregnancy has not produced consistent improvement in perinatal outcomes [22,27,47]. This finding, in conjunction with concerns that individuals who reduce the number of cigarettes smoked may compensate by inhaling deeper, has led to the recommendation that smoking cessation, not a reduction in the number of cigarettes smoked, should be the primary goal [10]. Moreover, it is likely that nondisclosure underestimates the effects of "cutting down." A placebo-controlled randomized trial of nicotine gum for smoking cessation during pregnancy reported similar quit rates in both the active drug and placebo groups; however, those in the nicotine gum group smoked fewer cigarettes and had lower cotinine levels and higher birth weights than those in the placebo group [48]. These findings support the recommendation that patients who are unable to quit smoking should still be encouraged to reduce the number of cigarettes they smoke each day.

BEHAVIORAL COUNSELING — Consistent with society recommendations, we offer smoking cessation behavioral counseling to all pregnant individuals and view counseling, with continued monitoring and behavioral interventions, as the first-line intervention for smoking cessation [21,30,49]. Counseling interventions can include motivational interviewing, cognitive behavioral therapy, psychotherapy, relaxation techniques, problem solving facilitation, and other strategies [26]. A meta-analysis of 30 studies (randomized trials, cluster-randomized trials, and quasi-randomized trials) reported counseling increased smoking cessation in late pregnancy compared with usual care (average risk ratio [RR] 1.44, 95% CI 1.19-1.73) [26]. The same meta-analysis also reported that, compared with usual care, counseling was associated with continued smoking abstinence at zero to five months postpartum (average RR 1.59, 95% CI 1.26-2.01, 11 studies) and at 12 to 17 months postpartum (average RR 2.20, 95% CI 1.23-3.96, 2 studies). A borderline effect was reported for the time frame 6 to 11 months (average RR 1.33, 95% CI 1.00-1.77, six studies). Importantly, patients who received psychosocial counseling had a 17 percent reduction in low birth weight infants, a higher mean birth weight (mean difference 55.60 g, 95% CI 29.82-81.38 g higher), and a 22 percent reduction in admission to the neonatal intensive care unit. At least one study has reported that use of a texting program targeted to pregnant women was associated with improved smoking cessation rates compared with baseline [50].

Behavioral interventions for smoking cessation in adults are discussed in additional detail elsewhere:

(See "Overview of smoking cessation management in adults", section on 'Behavioral counseling'.)

(See "Behavioral approaches to smoking cessation".)

PHARMACOTHERAPY

Drug use and selection — While cessation counseling is the first-line intervention for all pregnant persons who want to stop smoking, some individuals find that counseling is not enough to help them quit. Given the known harms of continued smoking during pregnancy and the benefits of smoking cessation, we offer pharmacotherapy in addition to cessation counseling to pregnant people who are otherwise unable to quit or who are at high risk for continued smoking. High-risk individuals include those who smoke heavily (>10 cigarettes per day), those smoking later in pregnancy, and those who have been unsuccessful in a previous attempt to stop. We believe the benefits of quitting with pharmacotherapy outweigh the potential risks of pharmacotherapy and the risks of continued smoking.

When pharmacotherapy for smoking cessation is utilized, general principles of prescribing drugs during pregnancy should be followed. These include using the lowest dose necessary to achieve success in order to minimize fetal exposure and, if possible, delaying therapy until the second trimester in order to avoid the period of embryogenesis when the fetus is most sensitive to teratogens. Despite concerns about underdosing due to the changes in pharmacokinetics due to pregnancy, we start with the lowest medication dose and titrate accordingly.

While both nicotine replacement therapy (NRT) and bupropion are reasonable drug options, the safety and efficacy of these drugs have not been directly compared in randomized trials including pregnant persons; thus, the optimal treatment is not known. Given the limited available data, it is reasonable to offer either NRT or bupropion as adjuncts to cessation counseling and ask the patient to participate in the selection (table 2). As data on varenicline use in pregnancy are lacking, we avoid varenicline in pregnant patients. When presented with this discussion, our patients generally opt for bupropion, but we also offer NRT.

NRT appears to be safe, but the efficacy of NRT in pregnancy is not well established. (See 'Nicotine replacement' below.)

Bupropion appears to be efficacious in pregnant people based on limited studies, but may be associated with a small increased risk of congenital malformations, specifically cardiac abnormalities. However, the data on fetal impact are limited, inconsistent, and might be confounded by additional factors such as maternal depression or concurrent use of other antidepressants. (See 'Bupropion' below.)

Society guidelines — Society guidelines differ in their approaches to pharmacotherapy in pregnancy, likely in part because the body of evidence on pharmacotherapy in pregnancy is small and evolving.

In 2017, and again in 2020, the American College of Obstetricians and Gynecologists (ACOG) stated that, for individuals with clear resolve to quit smoking, the use of NRT could be undertaken with close supervision and after a thorough discussion about the risks of continued smoking and the possible risks of replacement therapy with the patient [20,51]. This statement acknowledges both the significant negative impact of smoking on fetal outcomes and the benefit of adjunct pharmacotherapy on smoking cessation in nonpregnant individuals as well as the potential adverse fetal effects of nicotine [52]. ACOG also concluded that there was insufficient evidence supporting the use of bupropion or varenicline in pregnant or breastfeeding individuals based on an earlier publication by the United States Department of Health and Human Services (HHS) [30].

The European Network for Smoking and Tobacco Prevention (ENSP) 2016 guidelines for treating tobacco dependence stated that "it is vital for the mother to quit smoking as early as possible during the pregnancy and maintaining cessation is particularly important after the first trimester, due to the fact that the strongest adverse effects of smoking occur during the second and the third terms of pregnancy" [53]. The ENSP noted that in some European countries pregnancy was considered a contraindication to NRT and did not make a specific treatment statement but did acknowledge that the precautions had to be balanced against the high risks of continued smoking. Pregnancy and breastfeeding were listed as contraindications to use of bupropion and varenicline.

The 2021 United States Preventive Services Task Force (USPSTF) statement reaffirmed earlier ones and concluded that available data were insufficient to assess the balance of benefits and harms of pharmacotherapy use during pregnancy [18,30,49,54]. Behavioral interventions were advised for pregnant individuals. (See 'Behavioral counseling' above.)

The 2011 Society of Obstetricians and Gynecologists of Canada (SOGC) and the 2010 United Kingdom National Institute for Health and Care Excellent (NICE) guidelines both stated that trials failed to demonstrate that NRT clearly improved smoking cessation rates for pregnant persons and the safety of NRT in pregnancy was unknown [55,56]. However, both societies noted that pharmacotherapy with NRT could reasonably be offered to pregnant patients who desired smoking cessation but had been unable to quit with cessation counseling alone. Both guidelines stated that, if prescribing NRT, the clinician should discuss the benefits and risks of NRT in pregnancy. Neither organization advised use of bupropion or varenicline during pregnancy because safety data were insufficient.

Nicotine replacement — We use NRT in combination with counseling for smoking cessation in pregnancy. NRT includes short-acting gum, lozenges, nasal spray, and inhalers as well as long-acting transdermal patches. NRT does not include e-cigarettes. At least one organization advises NRT only for those individuals whose goal is smoking cessation [20].

NRT is one component of smoking cessation programs; it is an adjunct to behavioral intervention and counseling. Behavioral counseling on an ongoing basis is important and may enhance adherence to nicotine replacement [57,58]. (See 'Behavioral counseling' above.)

Efficacy — Although NRT is prescribed to help pregnant individuals stop smoking and appears to be an effective smoking cessation aid in the general population [52], studies have not clearly demonstrated that NRT is effective in pregnant persons as compared with controls. Examples of the conflicting body of evidence include:

A 2020 meta-analysis reported that, compared with placebo and nonplacebo controls, NRT as an adjunct to behavioral therapy increased the likelihood of smoking abstinence later in pregnancy (risk ratio [RR] 1.37, 95% CI 1.08-1.74, nine trials, n = 2336 pregnant adults) [43]. However, the subgroup analysis that compared NRT with placebo treatments demonstrated a nonsignificant trend toward a benefit (RR 1.21, 95% CI 0.95-1.55, n = 2063 women). In this meta-analysis, there were no differences between NRT-treated and control women in rates of miscarriage, stillbirth, premature birth, birth weight, low birth weight, admissions to neonatal intensive care unit, cesarean delivery, congenital abnormalities, or neonatal death. Nonserious adverse effects from NRT included headache, nausea, and local reactions (eg, skin irritation from patch).

In a subsequent questionnaire study of over 1200 pregnant women who smoked, women who used the nicotine patch to aid smoking cessation reported higher rates of smoking cessation compared with no NRT use (79 versus 0 percent) [59]. After discontinuing NRT, 68 percent of prior patch users did not smoke again during and up to one year after pregnancy. In adjusted analysis, NRT was also associated with a nearly 40 percent reduced risk for small for gestational age infants and 80 percent lower risk of prematurity compared with continued smoking. Pregnancies ending in stillbirth were excluded from the study.

A different trial of 1050 women reported that only 7 percent of patients in the nicotine patch intervention group adhered to nicotine replacement for more than one month [60]. One potential explanation for poor compliance and limited reduction in smoking is that nicotine is metabolized more rapidly in pregnancy; therefore, pregnant people in clinical trials may have been underdosed. In addition, some individuals are afraid to take nicotine replacement during pregnancy despite the fact that they are continuing to smoke.

A small trial that evaluated the use of nicotine gum did not find a significant difference in biochemically validated smoking cessation rates [48]. However, use of nicotine gum was associated with increased birth weight and gestational age [48].

Risks and benefits — There is no strong evidence that pregnant persons who smoke and use NRT are at higher risk of adverse perinatal events, including teratogenesis, than pregnant patients who smoke who do not use NRT [52,61]. In a trial of 1050 pregnant individuals who smoke randomly assigned to NRT or placebo, children exposed to nicotine replacement in utero had as good or better development outcomes at two-year follow-up compared with unexposed children [62]. Additionally, in a retrospective study of nearly 200,000 children born in the United Kingdom, the rates of major congenital anomalies were not statistically different among children born to women using NRT, women who were actively smoking and not using nicotine therapy, and women who did not use either [63]. There was a higher risk of congenital respiratory anomalies in the children exposed to NRT compared with those with no nicotine exposure (odds ratio 4.65, 99% CI 1.76-12.25), but the absolute risk difference was very small. Major limitations of this study include the low rate of NRT (1.3 percent of total group) and higher rates of maternal morbidities in the nicotine replacement and smoking groups.

While the fetal impact of NRT may not be fully known, NRT does not appear to be harmful and may be associated with lower rates of prematurity and small for gestational age infants [64]. Even if NRT cannot entirely reduce all of the risks associated with smoking during pregnancy, maternal smoking cessation results in less in-utero exposure of the fetus to non-nicotine cigarette toxins such as carbon monoxide that may also contribute to poor pregnancy outcomes. Additionally, assessment of the impact of NRT during pregnancy does not typically evaluate postnatal outcomes that are influenced by continued or resumed smoking, such as upper respiratory infections, asthma, hospital admission, otitis media, and sudden infant death syndrome. Therefore, the full effect of NRT may be underestimated.

Administration — For patients who elect a trial of NRT, administration is similar to that of nonpregnant adults. We generally begin with an intermediate dose patch and short-acting agents (eg, gum or lozenge) as needed for breakthrough symptoms (table 2). Administration of NRT in nonpregnant adults is described in detail separately. (See "Pharmacotherapy for smoking cessation in adults", section on 'Nicotine replacement therapy'.)

Use in labor — There is no information specifically on use of nicotine replacement products during labor. Based on available information on the physiological effects of these drugs on mother and fetus, there should be no additional risk from continuing their use intrapartum in patients who used them antepartum. In addition, they may be useful to reduce nicotine withdrawal symptoms in those who smoke heavily who are uncomfortable when hospitalization forces them to abstain from smoking.

Bupropion

Use and efficacy — We use bupropion (commercial name Zyban) as an adjunct to counseling. We use it as a first-line agent in individuals with a contraindication to NRT, those who wish to quit but are afraid to use NRT, or for patients who have been unable to quit with cessation counseling alone or with combined counseling and NRT. The woman is initially started on oral bupropion 150 mg once daily for three days and is then increased to 150 mg twice daily (maximum dose: 300 mg/day). The quit date should be set approximately a week after the start date to allow for adequate levels. NRT is stopped if bupropion is started.

Observational studies suggest that bupropion is an effective medication for smoking cessation in pregnancy [59,65].

In one of the first prospective, matched, controlled observational studies among pregnant women, pregnant persons who smoke receiving bupropion were significantly more likely to quit than pregnant controls (45 versus 14 percent) [65].

In a subsequent questionnaire study that included over 1200 pregnant persons who smoke, bupropion use was associated with much higher rates of smoking cessation compared with no bupropion use (81 versus 0 percent) [59]. Sixty percent of bupropion users did not smoke again during pregnancy or the first postpartum year. In addition, bupropion use was associated with an 88 percent reduced risk of prematurity, although the study only included data on live births and did not include patients with fetal deaths.

The comparison of bupropion with other agents in nonpregnant persons is discussed separately. (See "Pharmacotherapy for smoking cessation in adults", section on 'Bupropion'.)

Risks — Bupropion crosses the placenta. However, the data on fetal impact are limited, inconsistent, and might be confounded by additional factors such as maternal depression or concurrent use of other antidepressants. While a clear association with congenital malformations has not been established, we discuss the option of initiating medication after the first trimester ultrasound is performed (generally 11 to 14 weeks) so that we can evaluate the early fetal anatomy before starting treatment. After discussion of these data, some patients may choose to wait until the second trimester before beginning bupropion. Others may prefer to delay initiating therapy until the detailed anatomical ultrasound assessment is performed (generally 18 to 20 weeks). It is important for the expectant mother to be comfortable with the treatment timing as well as choice, which may also improve compliance. (See "Antenatal use of antidepressants and risks of teratogenicity and adverse pregnancy outcomes: Drugs other than selective serotonin reuptake inhibitors", section on 'Bupropion'.)

One small study (136 women) reported an increase in risk of miscarriage with use of bupropion in the first trimester compared with nonexposed women, but the risk remained within that of the general population [66,67]. Although there are conflicting data regarding the risk of congenital malformations, the body of evidence suggests that bupropion does not increase the overall risk [68]. The bupropion pregnancy registry report, published by the manufacturer, prospectively reviewed nearly 1600 pregnancies from 1997 to 2008 [69]. The committee concluded that the observed 3.6 percent incidence of congenital anomalies after first trimester exposure (n = 806) was consistent with the general population rate. They also noted repeated occurrence of heart defects, but concluded that the data were insufficient to evaluate if bupropion increased heart defect risk. A subsequent retrospective case-control study from the United States National Birth Defects Prevention Study reported an increased risk for left ventricular outflow tract heart defects (hypoplastic left heart, aortic stenosis, and aortic coarctation) with first trimester exposure to bupropion (adjusted odds ratio 2.6, 95% CI 1.2-5.7) but the wide confidence interval made the true magnitude of risk less clear [70]. Some of the women had also taken other antidepressants, which further complicated the analysis. Two subsequent population-based studies did not support this finding of an increased risk in left-sided lesions [71,72]. Furthermore, in one of the studies, an increase in ANY cardiac malformation was not observed after adjustment for depression severity, which suggests that the severity of depression is a confounder [73]. Subsequently, a meta-analysis of four studies reported no increased risk of congenital malformations with bupropion exposure during pregnancy (pooled estimated proportion 1.0, 95% CI 0.0-3.0) [68].

Varenicline — There is limited information on the safety of varenicline (commercial name Chantix) use in human pregnancy [67,74]. In an observational cohort study comparing varenicline-exposed pregnancies with either nonteratogen-exposed controls or to NRT or bupropion for smoking cessation, the rate of major congenital malformations was not different compared with nonexposed controls nor different from the expected background rate [74]. However, varenicline use was limited to the first trimester of all pregnancies, with most women stopping the drug early in the first trimester. Given the lack of information and the availability of alternative drugs, we avoid varenicline for smoking cessation in pregnant people.

Electronic cigarettes and vaping — Electronic nicotine delivery systems (ENDS), such as electronic cigarettes and vaporizers, are used by some pregnant individuals for smoking reduction; however, there is insufficient safety and efficacy data to recommend these devices during pregnancy [18]. One cohort study reported that ENDS users had higher rates of self-reported smoking abstinence in late pregnancy compared with NRT users (51 versus 19 percent), but only for individuals with prepregnancy ENDS use and not those who initiated ENDS in early pregnancy [75]. Despite the lack of supporting evidence, many believe ENDS are safer than traditional tobacco products [76]. More data are needed on the physiologic impact of ENDS on the pregnant person and developing fetus as well as the efficacy of these devices in smoking cessation. (See "Vaping and e-cigarettes", section on 'Role in smoking cessation'.)

Limited supporting data – In one trial including over 1100 pregnant individuals, the prespecified analysis (including only patients who used allocated products) reported improved cessation rates with electronic cigarettes compared with nicotine patches (cessation rates of 6.8 versus 3.3 percent, relative risk 0.93, 95% CI 1.14-3.26) [77]. Both arms received behavioral support that included six phone calls from stop-smoking advisors. Safety outcomes were similar for the two products except for reduced incidence of low birth weight (<2500 g) in the electronic cigarette group compared with the nicotine patch group (14.8 versus 9.6 percent, relative risk 0.65, 95% CI 0.47-0.90). However, definitive conclusions are limited because small numbers of confirmatory saliva samples were returned and similar cessation rates were reported in the intention-to-treat analysis (electronic cigarette 6.8 percent versus nicotine patch 4.4 percent).

Concern for toxins – Aerosols from electronic devices contain chemicals in addition to nicotine [78]; the impact of these agents during pregnancy is not yet known. A study that evaluated the role of the heating coil on the inhaled aerosol reported that electronically-generated vapor potentially contains toxic metals (chromium, nickel, and lead) as well as metals that are toxic when inhaled (manganese and zinc) [79].

INCENTIVE-BASED INTERVENTIONS — Incentive-based interventions appear effective at reducing smoking in the pregnant persons when compared with noncontingent incentives, although the overall quit rates remain low and postpartum smoking relapse is common [26,80-83].

In a multi-center UK trial including 944 pregnant persons that compared smoking cessation services with a financial incentive with smoking cessation services alone, financial incentives resulted in more than double the quit rate of usual care (27 versus 12 percent, adjusted odds ratio [OR] 2.78, 95% CI 1.94-3.97) [83]. However, by six months postpartum the biochemically verified nonsmoking rates had dropped to 6 and 4.4 percent, respectively.

In a single-blind trial that randomly assigned 460 pregnant individuals who smoked to either financial incentives or usual care, the continuous abstinence rate was more than double for the incentivized group (2.45, 95% CI 1.34-4.49) [82]. While financial incentives were associated with an increase in continuous abstinence rate throughout pregnancy, the absolute continuous abstinence rates remained low overall (16 percent for financial incentives versus 7 percent for usual care).

OTHER INTERVENTIONS — Other interventions for study in pregnancy include:

Increased education and/or support – It is unclear if health education and peer-group social support improve smoking cessation in pregnant people.

Complementary therapies – Acupuncture, meditation, and hypnotherapy have not been associated with improved quit-rates in nonpregnant adults [30], but pregnancy-specific data are lacking. (See "Overview of smoking cessation management in adults", section on 'Other interventions'.)

Computer-based applications (apps) – While one study of computer-based application during pregnancy did not report improved cessation rates [84], apps may have a role in smoking cessation as technology continues to evolve.

SPECIAL POPULATIONS

Breastfeeding persons — The optimal medication for smoking cessation in breastfeeding persons is not known. For those who used medication during pregnancy, we continue the same drug postpartum. For patients who wish to start a medication while breastfeeding, we discuss the risks and benefits of each medication based on the limited available data and ask the patient to participate in the medication selection.

Nicotine replacement therapy (NRT) – Use of a 21 mg transdermal nicotine patch results in nicotine breast milk levels that are equivalent to smoking 17 cigarettes daily [85]. Daily replacement should not exceed the amount of nicotine the woman typically consumes (assume a cigarette delivers 1 mg nicotine) as nicotine passes into milk, is orally absorbed as nicotine, and has been demonstrated to have adverse infant effects during breastfeeding. Despite these concerns, the risks of continued smoking are greater. In patients who are not already using medication to aid their smoking cessation efforts, we offer breastfeeding individuals NRT in conjunction with counseling. Of note, the 2013 Committee on Drugs of the American Academy of Pediatrics concluded that NRT was the preferred pharmacologic approach to smoking cessation in breastfeeding women, although the rationale for the statement is unclear as both NRT and bupropion are excreted into breastmilk [85-87].

Bupropion – Although no adverse effects in breastfeeding infants have been reported, available data are very limited [88]. In a lactation study, the average daily infant exposure to bupropion and its active metabolites was approximately 2 percent of the maternal weight-adjusted dose. In case reports, three infants did not show quantifiable levels of bupropion and its active metabolites. As with nicotine, a decision to prescribe bupropion to breastfeeding mothers needs to be balanced with the risks of continued smoking, which are likely greater than the risks of bupropion.

Varenicline – There are limited available data for varenicline during pregnancy and no available human data on varenicline in breastfed infants [67,74,89]. As such, NRT or bupropion are preferred over varenicline in breastfeeding women, particularly for newborn or preterm infants [20,89]. Women who use varenicline while breastfeeding are encouraged to monitor their infants for seizures and excessive vomiting.

Postpartum individuals

Postpartum relapse rates – Although many pregnant patients can remain smoke-free during their entire pregnancy, the Pregnancy Risk Assessment Monitoring System reported relapse rates of 42, 61, and 67 percent at 2 to 3, 4 to 5, and ≥6 months postpartum, respectively [90]. Similarly, a study from the United Kingdom reported 47 percent of women who had quit smoking during pregnancy relapsed within the first six weeks postpartum while others have reported relapse rates of up to 75 percent at 12 months postpartum [91,92]. Breastfeeding appears to reduce the risk of relapse [4,91-94].

Prevention of postpartum relapse – The optimal strategies for preventing postpartum relapse are not known [95,96].

Use of medical record – We suggest using in the medical record or problem list that a patient has recently quit smoking or using tobacco products so the high risk of postpartum recidivism is recognized and patients are offered additional support.

Use of postpartum programs – In a trial of postpartum individuals that compared enhanced cognitive behavioral therapy that focused on patient's postpartum concerns with a supportive time- and attention-controlled intervention, only 24 percent of those in each group remained tobacco-abstinent at one year [97]. Individuals with more depressive symptoms and higher levels of perceived stress were more likely to relapse. In a systematic review of 36 studies evaluating effectiveness of smoking relapse prevention interventions in nonpregnant abstinent former smokers, use of self-help materials or pharmacotherapy was modestly effective in preventing relapse at 12 to 18 months' follow-up (self-help materials odds ratio [OR] 1.5, nicotine replacement OR 1.3, bupropion OR 1.5); behavioral interventions were less effective [98].

Predictors of postpartum relapse – A systematic review of 31 studies reported the most common predictors of postpartum smoking relapse included being less well educated, younger, or multiparous, or living with a partner or household member who smoked [92]. The postpartum period is a period of great stress and emotional fluctuations, and lack of both social supports and coping skills has been implicated in relapse [92,99,100]. Lower mood scores have also been strongly associated with smoking relapse [92,101,102]. Approximately 50 to 70 percent of postpartum women report transient depressed mood or postpartum blues, making them vulnerable to relapse during this time. Women who relapse are more likely to have family members or friends who smoke and report less social support [95]. Relapsers are also more likely to report lower confidence for staying smoke-free [92]. Interestingly, studies looking at process of change variables have demonstrated that individuals who quit during pregnancy are more likely to see their quitting as temporary [103].

Treatment of postpartum relapse – Patients who are lactating and resume smoking postpartum are offered the treatment approaches discussed above. (See 'Breastfeeding persons' above.)

For patients who relapse postpartum and are not breastfeeding, we offer a combination of behavioral support and pharmacologic therapy. For most patients, we suggest either varenicline or a combination of two nicotine replacement products (such as a patch plus a short-acting form such as the gum or lozenge) as first-line pharmacologic therapy.

(See "Overview of smoking cessation management in adults".)

(See "Pharmacotherapy for smoking cessation in adults".)

Adolescents — Smoking cessation counseling and treatment options for teen patients is addressed separately. (See "Management of smoking and vaping cessation in adolescents".)

Partners and household members — Addressing partner and household smoking cessation is important because studies have reported lower quit rates for pregnant persons who live with persons who continue smoking. In addition, one observational study reported a potential generational impact of smoking, which raises questions of epigenetic changes related to tobacco exposure.

In a prospective cohort study of over 450 healthy pregnant persons who smoke in Spain, individuals were less likely to quit smoking if they had a partner who smoked compared with individuals whose partners who did not smoke [104]. While the smoking rates for mothers decreased throughout pregnancy, there was only minimal decrease in the smoking rates of partners.

In a meta-analysis that included over 500,000 women who smoked prior to pregnancy, having a partner or household member who continued to smoke reduced the chance of smoking cessation during pregnancy by more than 50 percent (pooled odds ratio 0.46, 95% CI 0.35-0.50) [105].

In a Norwegian cohort study that included >100,000 children, offspring attention deficit hyperactivity disorder (ADHD) was not more strongly associated with maternal smoking compared with paternal smoking, grandmother's smoking when pregnant with mother, or maternal smoking in previous pregnancies [106].

Areas for future study include using combined patient/partner cessation strategies and/or family-based interventions (including other engaged family members such as grandparents).

RESOURCES FOR PATIENTS AND CLINICIANS

World Health Organization provides a free tobacco fact sheet as well as tool kits for health care providers

The American College of Obstetricians and Gynecologists has a Frequency Asked Questions infographic on "Tobacco and Pregnancy" available online for free in English and Spanish.

Centers for Disease Control and Prevention

The US National Institutes of Health site smokefree.gov provides patient information and links to phone quit lines with trained counselors (1-800-QUIT-NOW)

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Smoking cessation, e-cigarettes, and tobacco control".)

INFORMATION FOR PATIENTS — UpToDate offers two types of patient education materials, "The Basics" and "Beyond the Basics." The Basics patient education pieces are written in plain language, at the 5th to 6th grade reading level, and they answer the four or five key questions a patient might have about a given condition. These articles are best for patients who want a general overview and who prefer short, easy-to-read materials. Beyond the Basics patient education pieces are longer, more sophisticated, and more detailed. These articles are written at the 10th to 12th grade reading level and are best for patients who want in-depth information and are comfortable with some medical jargon.

Here are the patient education articles that are relevant to this topic. We encourage you to print or e-mail these topics to your patients. (You can also locate patient education articles on a variety of subjects by searching on "patient info" and the keyword(s) of interest.)

Basics topics (see "Patient education: Smoking in pregnancy (The Basics)" and "Patient education: Secondhand smoke and children (The Basics)")

Beyond the Basics topics (see "Patient education: Quitting smoking (Beyond the Basics)")

SUMMARY AND RECOMMENDATIONS

Prevalence of smoking cessation during pregnancy – Available data indicate that 35 to 75 percent of pregnant persons who smoke completely stop smoking by the end of pregnancy. Most pregnant patients who are able to quit smoking by themselves during pregnancy do so prior to their first prenatal visit. (See 'Epidemiology of smoking cessation' above.)

Ask about tobacco use during pregnancy – There is expert consensus that pregnant individuals who use tobacco should be identified early in pregnancy and provided augmented, pregnancy-tailored counseling on smoking cessation. Despite evidence that brief interventions work to reduce maternal smoking, it is estimated that only approximately half of obstetricians routinely advise and provide follow-up for smoking cessation, and only 28 percent discuss actual strategies for cessation. (See 'Impact of health care provider intervention' above.)

Questions to identify tobacco use – The five A's (ask, advise, assess, assist, and arrange) provide a general approach to asking patients about cigarette and tobacco use and helping patients stop smoking (table 1). The specific action steps have been gathered from various investigators and guideline panels and are not exclusive to pregnant persons. Additionally, we address tobacco use at every subsequent prenatal visit to track progress, reinforce success, and provide ongoing assistance to those who continue to smoke. (See 'General questions (5 A's) to smoking cessation' above.)

Advise quitting – All individuals who smoke should be advised to quit. We also refer patients with additional comorbidities (such as anxiety, depression, or substance use) that can contribute to continued smoking for further evaluation and treatment. (See 'Our approach' above.)

Behavioral counseling – For all pregnant individuals who smoke, we recommend a behavioral counseling program (Grade 1B). Compared with usual care, these programs result in modest improvement in postpartum abstinence and pregnancy outcomes.

Nicotine replacement therapy – In addition, for pregnant individuals who smoke heavily or are unable to quit with behavioral counseling alone, we suggest adjunctive pharmacotherapy with nicotine replacement therapy (NRT) (Grade 2C).

Additional pharmacotherapyBupropion is a reasonable alternative to NRT as adjunctive pharmacotherapy. The safety data for NRT are from more robustly designed studies compared with bupropion (trial versus observational data). We do not use varenicline for smoking cessation in pregnant individuals because of the lack of safety information.

Timing of smoking cessation – Although smoking cessation during pregnancy is of maximal benefit if it occurs early in the first trimester, quitting at any time during pregnancy can have some beneficial effects. Patients are more likely to be successful if encouraged to quit rather than cut down. (See 'Abstinence versus reduction' above.)

Risk of postpartum relapse – Postpartum relapse is a significant problem, with approximately 50 percent of quitters relapsing in the first two months after delivery. These individuals should be considered "at risk" and provided with ongoing support. (See 'Postpartum individuals' above.)

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Topic 115306 Version 32.0

References

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