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Strengthen the Evidence for Maternal and Child Health Programs

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Evidence Tools
MCHbest. Smoking During Pregnancy.

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Strategy. Pharmacotherapy (Pregnancy)

Approach. Use nicotine replacement therapy (NRT) or other pharmacological agents to reduce smoking during pregnancy

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Overview. The current evidence is insufficient to assess the balance of benefits and harms of nicotine replacement (NRT) products or other pharmaceuticals for smoking cessation during pregnancy.[1,2] NRT used for smoking cessation in pregnancy may increase smoking cessation rates in late pregnancy; however, this evidence is of low certainty.[3] Multiple studies suggest that e-cigarettes (a form of NRT) are perceived by many pregnant women as less harmful than tobacco smoking.[4,5] However, it remains unclear whether they are more likely than nicotine patches or other pharmaceuticals to increase cessation rates.
[6] Also, there are concerns about the toxic properties of chemicals present in e-cigarette liquids and the additional chemicals generated during aerosolization.[7] There is no clear evidence that NRT used for smoking cessation in pregnancy has either positive or negative impacts on birth outcomes.[8] Therefore, it is recommended that pregnant women try to quit smoking without using NRT or pharmacological agents such as bupropion or varenicline, if at all possible. These have not been sufficiently tested for safety in pregnant patients and should not be used as first-line smoking cessation strategies.[8,9] When pharmacotherapy is used to deter smoking in pregnancy, combining group or individual behavioral therapy is likely to increase the likelihood of quitting.[10]

Evidence. Mixed Evidence. Strategies with this rating have been tested more than once with results that sometimes trend positive...

Access the peer-reviewed evidence through the MCH Digital Library or related evidence source.

Potential Data Sources. Data to support this strategy can be accessed through:

  • Tracking of NRT/Pharmacological agent provision and counseling integration
  • Patient satisfaction surveys
  • Engagement survey data on integration with comprehensive smoking cessation programs and referral networks

Outcome Components. This strategy has shown to have impact on the following outcomes (Read more about these categories):

  • Health and Health Behaviors/Behavior Change. This strategy improves individuals' physical and mental health and their adoption of healthy behaviors (e.g., healthy eating, physical activity).
  • Policy. This strategy helps to promote decisions, laws, and regulations that promote public health practices and interventions.
  • Utilization. This strategy improves the extent to which individuals and communities use available healthcare services.

Detailed Outcomes. For specific outcomes related to each study supporting this strategy, access the peer-reviewed evidence and read the Intervention Results for each study.

Intervention Type. Direct Care (Read more about intervention types and levels as defined by the Public Health Intervention Wheel).

Intervention Level. Individual/Family-Focused

Examples from the Field. Access descriptions of ESMs that use this strategy or aligned components.

Sample ESMs. Here are sample ESMs to use as models for your own measures using the RBA framework (see The Role of Title V in Adapting Strategies).

Quadrant 1:
Measuring Quantity of Effort (“What/how much did we do?”)

  • Number of pregnant women who smoke screened for eligibility and contraindications for pharmacotherapy. (Measures identification of potential treatment candidates)
  • Number of providers trained on appropriate use of pharmacotherapy for smoking cessation during pregnancy. (Evaluates workforce capacity building)

Quadrant 2:
Measuring Quality of Effort (“How well did we do it?”)

  • Percent of pregnant women prescribed pharmacotherapy who receive close monitoring and follow-up. (Measures quality of care and risk management)
  • Percent of pharmacotherapy prescriptions that align with clinical guidelines for product selection and dosage. (Assesses fidelity to evidence-based practices)

Quadrant 3:
Measuring Quantity of Effect (“Is anyone better off?”)

  • Number of healthcare organizations that develop policies and protocols to guide pharmacotherapy use in pregnancy. (Measures systems-level practice standardization)
  • Number of surveillance systems that track utilization, safety, and outcomes of pharmacotherapy for cessation in pregnancy. (Evaluates population health monitoring infrastructure)
  • Number of pregnant women who successfully quit using pharmacotherapy and report improved pregnancy and birth outcomes. (Assesses maternal and child health benefits)
  • Number of studies conducted to address evidence gaps related to pharmacotherapy safety and efficacy in pregnancy. (Measures research to inform practice)

Quadrant 4:
Measuring Quality of Effect (“How are they better off?”)

  • Percent of pharmacotherapy access improvement efforts tailored to pregnant women without insurance. (Measures focus of systems changes)
  • Percent of providers serving focus populations who receive training and support for pharmacotherapy use in pregnancy. (Assesses workforce development for health outcomes)
  • Percent of pregnant women using pharmacotherapy who achieve cessation by late pregnancy. (Measures effectiveness in promoting quitting)
  • Percent of pregnant women using pharmacotherapy who maintain abstinence postpartum. (Assesses duration of treatment effect)

Note. When looking at your ESMs, SPMs, or other strategies:

  1. Move from measuring quantity to quality.
  2. Move from measuring effort to effect.
  3. Quadrant 1 strategies should be used sparingly, when no other data exists.
  4. The most effective measurement combines strategies in all levels, with most in Quadrants 2 and 4.

Learn More. Read how to create stronger ESMs and how to measure ESM impact more meaningfully through Results-Based Accountability.

References

1 Siu, A. L., & U.S. Preventive Services Task Force (2015). Behavioral and Pharmacotherapy Interventions for Tobacco Smoking Cessation in Adults, Including Pregnant Women: U.S. Preventive Services Task Force Recommendation Statement. Annals of internal medicine, 163(8), 622–634. https://doi.org/10.7326/M15-2023
2 Berlin I, Grange G, Jacob N, Tanguy ML. Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy. BMJ 2014;348:1622.
3 Claire R, Chamberlain C, Davey MA, Cooper SE, Berlin I, Leonardi-Bee J, & Coleman T. (2020). Pharmacological interventions for promoting smoking cessation during pregnancy. The Cochrane database of systematic reviews, 3(3), CD010078. https://doi.org/10.1002/14651858.CD010078.pub3
4 Breland, A., McCubbin, A., & Ashford, K. (2019). Electronic nicotine delivery systems and pregnancy: Recent research on perceptions, cessation, and toxicant delivery. Birth defects research, 111(17), 1284–1293. https://doi.org/10.1002/bdr2.1561
5 Campbell, K., Coleman-Haynes, T., Bowker, K., Cooper, S. E., Connelly, S., & Coleman, T. (2020). Factors influencing the uptake and use of nicotine replacement therapy and e-cigarettes in pregnant women who smoke: a qualitative evidence synthesis. The Cochrane database of systematic reviews, 5(5), CD013629. https://doi.org/10.1002/14651858.CD013629
6 Hajek, P., Przulj, D., Pesola, F., Griffiths, C., Walton, R., McRobbie, H., Coleman, T., Lewis, S., Whitemore, R., Clark, M., Ussher, M., Sinclair, L., Seager, E., Cooper, S., Bauld, L., Naughton, F., Sasieni, P., Manyonda, I., & Myers 7 Smith, K. (2022). Electronic cigarettes versus nicotine patches for smoking cessation in pregnancy: a randomized controlled trial. Nature medicine, 28(5), 958–964. https://doi.org/10.1038/s41591-022-01808-0
7 Patnode, C. D., Henderson, J. T., Melnikow, J., Coppola, E. L., Durbin, S., & Thomas, R. (2021). Interventions for Tobacco Cessation in Adults, Including Pregnant Women: An Evidence Update for the U.S. Preventive Services Task Force. Agency for Healthcare Research and Quality (US).
8 Chamberlain (2020).
9 American College of Obstetricians and Gynecologists (2020). Tobacco and nicotine replacement therapy during pregnancy. ACOG Committee Opinion 807. Obstetrics and Gynecology. 135:221-129.
10 Stead, L. F., Koilpillai, P., Fanshawe, T. R., & Lancaster, T. (2016). Combined pharmacotherapy and behavioural interventions for smoking cessation. The Cochrane database of systematic reviews, 3, CD008286. https://doi.org/10.1002/14651858.CD008286.pub3

This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under grant number U02MC31613, MCH Advanced Education Policy, $3.5 M. This information or content and conclusions are those of the author and should not be construed as the official position or policy of, nor should any endorsements be inferred by HRSA, HHS or the U.S. Government.