Is it appropriate to prescribe nicotine patches for smoking cessation in a pregnant woman who smokes?

Nicotine Patches in Pregnancy: Clinical Recommendation

Behavioral counseling should be the first-line treatment for smoking cessation in pregnancy, but if this fails, nicotine patches may be prescribed under physician supervision after shared decision-making, as NRT is likely safer than continued smoking despite uncertain efficacy. 1, 2

Treatment Algorithm

Step 1: Initiate Intensive Behavioral Counseling First

• All pregnant smokers must receive intensive behavioral counseling as the initial intervention, which increases cessation rates from approximately 11% to 15% in late pregnancy. 1, 2
• Effective counseling requires at least 4 sessions with 91-300 minutes total contact time, providing messages tailored for pregnancy about maternal and fetal health effects, practical problem-solving skills, and strong advice to quit. 1, 2
• Behavioral counseling alone reduces low birth weight (RR 0.83) and increases mean birth weight by 55.6 grams with no adverse events reported. 1, 2

Step 2: Consider NRT Only After Behavioral Counseling Fails

• For pregnant women smoking ≤5 cigarettes per day: Use behavioral support only, do not prescribe NRT. 3
• For pregnant women with moderate to high nicotine dependence who cannot quit with counseling alone: NRT patches may be prescribed under physician supervision through shared decision-making. 1, 2, 3

Evidence on NRT Efficacy and Safety

Limited Efficacy Data

• Five placebo-controlled trials showed NRT trends toward benefit but no statistically significant increase in smoking cessation (11.9% with NRT vs 10.1% with placebo; RR 1.11,95% CI 0.79-1.56). 1
• Adherence to NRT in pregnancy trials was extremely low (<10% in some studies), substantially limiting assessment of both efficacy and safety. 1, 4

Safety Considerations

• NRT is FDA Pregnancy Category D (positive evidence of fetal risk, but potential benefits may warrant use). 2
• NRT is believed safer than continued smoking because cigarette smoke contains thousands of chemicals including carbon monoxide and lead, whereas NRT delivers only nicotine. 1, 2
• Reported adverse events with NRT include slightly increased diastolic blood pressure, skin reactions to patches, and low-risk cardiovascular events like tachycardia. 1, 2
• Perinatal outcomes with NRT showed inconsistent and imprecise findings across trials. 1

Practical Implementation

Prescribing Guidelines

• Minimum 12 weeks of therapy for initial quit attempt. 2
• Schedule follow-up within 2 weeks after starting NRT. 2
• Continue intensive behavioral counseling throughout NRT use—combination therapy is most effective. 2, 3
• Strongly advise that NRT must be stopped if the mother resumes smoking to avoid dual exposure. 2

Shared Decision-Making Discussion Points

• Emphasize that smoking during pregnancy causes documented severe harms: fetal growth restriction, preterm birth, low birth weight, stillbirth (25-50% increased risk), placental complications, and increased perinatal mortality. 1, 5
• Explain that quitting early in pregnancy (before 15 weeks) provides greatest benefit and can reduce or eliminate adverse effects on fetal growth. 1, 5
• Discuss that while NRT efficacy in pregnancy is uncertain, it likely poses less risk than continued smoking. 1, 2
• Consider severity of tobacco dependence when weighing risks and benefits. 1

Critical Pitfalls to Avoid

• Never prescribe NRT as first-line treatment without attempting behavioral counseling first. 2
• Do not prescribe NRT to light smokers (≤5 cigarettes/day)—behavioral support alone is appropriate. 3
• Do not recommend bupropion or varenicline in pregnancy—no safety or efficacy data exist for these agents. 1
• Do not recommend e-cigarettes—no trials have evaluated them for smoking cessation in pregnancy, and they contain numerous potentially toxic substances. 1
• Address postpartum relapse risk—approximately 50% of quitters relapse within 2 months after delivery and require ongoing support. 6