Smoking Cessation Counseling for Pregnancy
Palo Alto (17 mi)Overseen byKathryn I Pollak, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Duke University
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The investigators propose to conduct a combined intervention that pairs SMS smoking cessation messages for patients with individualized training for OB clinicians to improve quit rates among pregnant smoking. The aim is to determine the effect of the intervention versus control on smoking cessation outcomes on patient smoking cessation. The investigators will recruit patients at their first OB visit who report smoking at Duke and Pitt. Patients in both the control and intervention arm will receive smoking cessation support messages throughout their pregnancy. OB clinicians in the intervention arm will receive tailored smoking cessation counseling training. Clinicians in both arms will receive a one-time 5 A lecture. The investigators will analyze smoking cessation outcomes and audio recordings. This is a minimal risk study.
Is the Clinician Communication Intervention a promising treatment for helping pregnant women quit smoking?Yes, the Clinician Communication Intervention is promising because it involves effective counseling techniques that can help pregnant women quit smoking. Studies show that counseling, especially when tailored to pregnant women, can significantly increase quit rates. This approach is supported by healthcare providers and can lead to better health outcomes for both mothers and babies.1491011
What safety data exists for smoking cessation counseling during pregnancy?The reviewed studies emphasize the importance of smoking cessation counseling during pregnancy to prevent harm to both the mother and child. The 5 A's intervention, a low-intensity method integrated into prenatal care, is highlighted as effective. It involves a structured counseling session that increases cessation rates by 30-70% for women smoking less than 20 cigarettes per day. The studies suggest that this method is safe and beneficial, with no specific safety concerns reported. Additionally, the integration of behavioral counseling with pharmacotherapies, when necessary, is recommended to support smoking cessation during pregnancy.5791112
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Smoking Cessation Counseling for Pregnancy is an effective treatment?The available research shows that Smoking Cessation Counseling for Pregnancy is effective in helping pregnant women quit smoking. One study found that a short counseling session with pregnancy-specific educational materials increased quit rates by 30-70% for women who smoked less than 20 cigarettes per day. Another study indicated that 43% of women who received a personalized intervention were not smoking by the 34th week of pregnancy, compared to 34% in the control group. These findings suggest that this treatment can significantly help pregnant women stop smoking, which is important for improving pregnancy outcomes.23568
Eligibility Criteria
This trial is for pregnant women over 18 who smoke and are getting prenatal care from a participating OB clinician. They must have smoked tobacco at their first OB visit, be able to speak and read English, and have access to a cell phone that can send texts.Inclusion Criteria
I am 18 years old or older.
Treatment Details
The study tests whether combining SMS smoking cessation messages with specialized training for OB clinicians improves quitting rates among pregnant smokers compared to just receiving the messages. Participants will be analyzed based on their quit rates and interactions with clinicians.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment2 Interventions
Clinicians in the intervention arm will receive a tailored communication training on smoking cessation skills and a general lecture on smoking cessation.
Group II: ControlActive Control1 Intervention
Clinicians in the control arm will be asked to attend a lecture on general information about smoking cessation for pregnant patients and smoking cessation counseling.
Clinician Communication Intervention is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Smoking Cessation Counseling for:
- Smoking cessation in pregnant women
🇪🇺 Approved in European Union as 5 A's Intervention for:
- Smoking cessation in pregnant women
- General smoking cessation
🇨🇦 Approved in Canada as Clinician Communication Intervention for:
- Smoking cessation in pregnant women
Find a clinic near you
Research locations nearbySelect from list below to view details:
Durham OBDurham, NC
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Who is running the clinical trial?
Duke UniversityLead Sponsor
University of PittsburghCollaborator
References
A simple, effective method that midwives can use to help pregnant women stop smoking. [2019]Recent studies suggest that few maternity care providers are offering the assistance that women need to reduce or stop smoking during pregnancy. This is probably because of a lack of conviction among providers that they can be effective, a perception that they lack counseling skills, and the absence of reimbursement for counseling and self-help materials. Midwives have strong counseling skills and materials will soon be available that can help them and others become trained smoking counselors. Thus, midwives can easily adopt the techniques that have been shown effective in reducing or stopping smoking during pregnancy. These are a 5- to 10-minute counseling session at the first prenatal visit by a trained provider plus appropriate print materials (pregnancy-specific and culturally- and reading-level-appropriate). Guiding the smoker to select a date for quitting and checking on smoking status at each visit increase the likelihood of behavior change. These techniques should increase the quit rate, over spontaneous quitting, by 10%-20%. Managed care organizations looking for ways to reduce costly hospitalizations for low birth weight infants or ambulatory care visits for smoking-related illnesses in infants and children should support this intervention. Medicaid and tobacco settlement funds are potential sources of reimbursement for counseling and educational materials.
Smoking cessation in pregnant women. [2019]Cigarette smoking is considered the most significant modifiable cause of adverse pregnancy outcomes in US women. Smoking cessation in pregnant patients is one of the most effective ways to reduce negative pregnancy outcomes of fetal growth retardation, preterm delivery, and perinatal mortality. Research evidence documenting the effectiveness of health care provider interventions in smoking cessation has led to the PHS recommendation to screen and counsel every patient. Materials from the PHS and NCI are available to assist health care providers in developing a brief office-based intervention. Patient materials for distribution are also available. Increased use of office-based cessation strategies, of cessation programs in community-based interventions, and of pharmacologic therapies is necessary to remedy the public health burden of fetal exposure to tobacco. Relapse prevention methods using office-based and social support systems are important to improve long-term maintenance of cessation in women who quit smoking during pregnancy.
One-to-one: a motivational intervention for resistant pregnant smokers. [2022]The purpose of this prospective, randomized controlled study was to determine the efficacy of an intensified, late pregnancy, smoking cessation intervention for resistant pregnant smokers (n = 269). Participants received 3-5 min of counseling plus a self-help booklet at their first prenatal visit and seven booklets mailed weekly thereafter; at 28 weeks, all had been smoking in the past 28 days. The experimental group received a stage of change-based, personalized feedback letter and two telephone counseling calls using Motivational Interviewing (MI) strategies. The control group received care as usual. The 34th week cotinine data demonstrated no overall difference between groups. However, an implementation analysis suggested that 43% of women who received the full intervention (E2) were classified as not smoking compared to 34% of the control group. At 6 weeks postpartum, 27.1% of the E2 group reported being abstinent or light smokers vs. 14.6% of the controls. No differences were detected at 3 and 6 months postpartum. Results lend preliminary but very modest support for this intervention with resistant pregnant smokers. Improvements in the intervention and implementation issues are discussed.
Smoke free families: a tobacco control program for pregnant women and their families. [2019]Tobacco use during pregnancy continues to cause health problems for women and children. Nurses can facilitate smoking cessation during pregnancy through the use of tobacco control guidelines and counseling tailored to pregnant women. In this article, the Treating Tobacco Use and Dependence: Clinical Practice Guideline is reviewed; the Smoke Free Families program, which is tailored for pregnancy, stage matched, and includes second-hand smoke control assistance, is described; and two models for integrating smoking cessation counseling into prenatal services are offered.
Smoking cessation during pregnancy. [2015]Smoking during pregnancy is associated with maternal, fetal, and infant morbidity and mortality. An office-based protocol that systematically identifies pregnant women who smoke and offers treatment has been proven to increase quit rates. For pregnant women who smoke less than 20 cigarettes per day, the provision of a 5-15 minute, five-step counseling session and pregnancy-specific educational materials increases cessation by 30-70%. This bulletin outlines this office-based intervention and addresses treatment issues pertaining to pregnant women who smoke heavily, smoking reduction, pharmacotherapy, healthcare support systems, and coding.
Making the sale: communicating the importance of smoking cessation to pregnant patients. [2017]The risks that smoking pose to the pregnant patient and her fetus have been well established. Some women quit smoking upon learning they are pregnant, but most do not. Although a direct, succinct intervention by the physician has proven to be a critical initial step in helping the patient to quit smoking, some physicians are not taking advantage of this opportunity. This article provides data obtained from focus groups conducted with pregnant West Virginia smokers. These women spoke very candidly about their experiences with their providers. Chances for succeeding with helping a patient to quit smoking are likely to increase if physicians discuss smoking with their patients at each visit and if it is done in a constructive manner.
[Health Professionals' Interventions for promoting smoking cessation during pregnancy: a review of the evidence]. [2017]Active and passive exposure to tobacco smoke during pregnancy is the most serious and preventable cause of adverse maternal, fetal, and infant outcomes in France. The clinical and economic benefits of cessation have been documented. The objective of this article is to review the evidence base addressing smoking cessation in pregnant women. The article describes how best to assist the pregnant smoker in clinical practice or hospital to quit during pregnancy. The following low intensity interventions designed to be integrated into routine prenatal care are detailed: expired air CO measures, practice of the evidence-based 5 A's smoking cessation intervention for pregnant women, use of pregnant woman's self-help guide to quit smoking, relapse prevention, health professionals' training, participation to community program.
ACOG committee opinion. Number 316, October 2005. Smoking cessation during pregnancy. [2022]Smoking is one of the most important modifiable causes of poor pregnancy outcomes in the United States. An office-based protocol that systematically identifies pregnant women who smoke and offers treatment has been proven to increase quit rates. For pregnant women who are light to moderate smokers, a short counseling session with pregnancy-specific educational materials often is an effective intervention for smoking cessation. The 5 A's is an office-based intervention developed for use by trained practitioners. Techniques for smoking reduction, pharmacotherapy, and health care support systems can help smokers quit.
Efficacy of telephone counseling for pregnant smokers: a randomized controlled trial. [2022]Reducing tobacco use in pregnancy is a public health priority. Brief smoking counseling during prenatal care is effective but generates modest cessation rates. Telephone counseling is an effective smoking cessation method that could offer pregnant women convenient access to more intensive smoking cessation counseling.
Committee opinion no. 471: Smoking cessation during pregnancy. [2010]Smoking is the one of the most important modifiable causes of poor pregnancy outcomes in the United States, and is associated with maternal, fetal, and infant morbidity and mortality. The physical and psychologic addiction to cigarettes is powerful; however, the compassionate intervention of the obstetrician–gynecologist can be the critical element in prenatal smoking cessation. An office-based protocol that systematically identifies pregnant women who smoke and offers treatment or referral has been proved to increase quit rates. A short counseling session with pregnancy-specific educational materials and a referral to the smokers’ quit line is an effective smoking cessation strategy. The 5A’s is an office-based intervention developed to be used under the guidance of trained practitioners to help pregnant women quit smoking. Knowledge of the use of the 5A’s, health care support systems, and pharmacotherapy add to the techniques providers can use to support perinatal smoking cessation.
Does government supervision improve stop-smoking counseling in midwifery practices? [2022]Smoking-cessation counseling during pregnancy is important to prevent smoking-related harm in pregnant smokers and their children. Therefore we evaluated the effects of an Inspectorate's supervision programme on the provision of smoking-cessation counseling by midwifery practices in the Netherlands. The supervision programme consisted of 3 elements: A) A deadline was announced by which all practices should comply with professional norms on such counseling (2011); B) A set of randomly selected practices were assessed using a questionnaire and a personal feedback report (2010); C) Another set of randomly selected practices were assessed through a site visit and a personal feedback report (2012).
Nicotine Use During Pregnancy: Cessation and Treatment Strategies. [2023]The use of tobacco and nicotine products during pregnancy is known to increase the risk of adverse effects on the fetus. Increased education and research have resulted in greater rates of smoking cessation during pregnancy, with a decline from 13.2% of pregnant individuals smoking in 2006 to 7.2% in 2016. However, smoking while pregnant still proves to be a prevalent issue that is associated with numerous adverse outcomes, including low birth weight, preterm birth, and developmental delays. Smoking cessation before or during pregnancy can help mitigate these effects, but the appropriate treatment can be challenging to ascertain. Accordingly, clinicians should look to provide individualized care composed of behavioral counseling in conjunction with pharmacotherapies when indicated, combined with ongoing support and education.