What is the best approach for a pregnant individual at 12 weeks gestation who smokes and is concerned about fetal wellbeing?

Smoking Cessation in Pregnancy at 12 Weeks

The best approach is intensive behavioral counseling with multiple sessions using pregnancy-specific materials; pharmacotherapy should NOT be first-line, and e-cigarettes and varenicline should be avoided entirely in pregnancy. 1, 2

Primary Recommendation: Behavioral Interventions

Behavioral counseling is the only intervention with established safety and effectiveness in pregnancy and must be the foundation of treatment. 2 The evidence shows:

• Intensive behavioral interventions increase smoking abstinence rates from 11% to 15% in pregnant women and improve birth outcomes including increased birthweight (mean difference 40.78g) and reduced preterm birth (RR 0.82). 1

• Effective interventions require more than brief advice—they need multiple counseling sessions (≥4 sessions) with 91-300 minutes of total contact time, augmented with pregnancy-specific educational materials. 1, 2

• Counseling must include clear messages about effects on both maternal and fetal health, with strong advice to quit as soon as possible, emphasizing that quitting at 12 weeks still provides substantial fetal benefit. 1, 2

• Refer to specialized cessation programs, support groups, or telephone quitlines, as these structured interventions with trained counselors are more effective than routine prenatal care advice alone. 2

Why the Listed Options Are Inappropriate

Option A: Bupropion + Fetal Monitoring - NOT RECOMMENDED

Bupropion should not be used in pregnancy for smoking cessation. The evidence is clear:

• A 2021 placebo-controlled trial (N=129) found bupropion was NOT efficacious for smoking cessation in pregnant women (quit rates: bupropion 11.0% vs placebo 18.5% at end of treatment). 3

• No adequate well-controlled studies of bupropion use during pregnancy exist, and it is FDA pregnancy category C with animal studies showing fetal harm. 1, 4

• The USPSTF found no evidence on bupropion for smoking cessation in pregnancy and concluded the balance of benefits and harms cannot be determined. 1

Option B: Switch to E-Cigarettes - NOT RECOMMENDED

E-cigarettes should be avoided in pregnancy:

• No trials have evaluated e-cigarettes for smoking cessation in pregnant women, and the USPSTF concluded evidence is insufficient with unknown balance of benefits and harms. 1

• E-cigarette effects on the fetus are unknown, and they contain potentially toxic substances. 1, 5

• The USPSTF specifically states that given established safety and effectiveness of behavioral interventions, providers should direct patients to these other interventions rather than e-cigarettes. 1

Option C: Varenicline - CONTRAINDICATED

Varenicline is absolutely not recommended in pregnancy:

• No published trials exist on varenicline use during pregnancy for smoking cessation. 1, 6

• Varenicline is a nicotinic receptor partial agonist with unknown fetal effects, and FDA labeling states available studies cannot definitively establish or exclude varenicline-associated risk during pregnancy. 1, 4

• The USPSTF found no evidence on varenicline in pregnant women, and the balance of benefits and harms cannot be determined. 1

Option D: Smoke Less - INADEQUATE

While harm reduction has theoretical appeal, "smoke less" without structured behavioral intervention is insufficient:

• The evidence supports complete cessation, not reduction, as the primary goal, though any reduction provides some benefit. 1

• If reduction is pursued, it must be within a structured gradual cessation program with behavioral support, reducing by 50% in first 4 weeks, another 50% in next 4 weeks, with goal of complete abstinence by 12 weeks. 4

When Behavioral Interventions Fail: Considering NRT

Only after intensive behavioral interventions have failed should NRT be considered, and only with detailed informed consent about risks versus benefits of continued smoking. 2

The evidence on NRT in pregnancy is mixed:

• Meta-analysis of 9 trials (N=2336) showed NRT may increase cessation rates (RR 1.37), but this effect disappeared when only placebo-controlled trials were analyzed (RR 1.21, not statistically significant). 6

• NRT is FDA pregnancy category D (positive evidence of fetal risk), though it may be safer than continued smoking since it lacks carbon monoxide and other combustion toxins. 1

• ACOG recommends NRT only after detailed discussion of known smoking risks versus possible NRT risks, with close supervision. 2

• If NRT is used, start with short-acting forms (gum, lozenges) rather than patches to allow more controlled nicotine exposure. 2

• Adherence to NRT in pregnancy trials was very low (<25%), limiting effectiveness. 1, 6

Critical Implementation Points

At 12 weeks gestation, immediate action is needed:

• Enroll in intensive behavioral counseling program immediately—quitting early in pregnancy provides greatest fetal benefit. 1, 2

• Avoid pharmacotherapy as first-line treatment—behavioral interventions are the only approach with proven safety and effectiveness. 1, 2

• Plan for multiple counseling sessions with pregnancy-specific materials addressing maternal and fetal health impacts. 1, 2

• Arrange close follow-up—inadequate follow-up is a common pitfall, as cessation requires ongoing support with repeated quit attempts encouraged. 2