Efficacy of a Nurse-Delivered Intervention to Prevent and Delay Postpartum Return to Smoking: The Quit for Two Trial.

INTRODUCTION: Most pregnant women who quit smoking return to smoking postpartum. Trials to prevent this return have been unsuccessful. We tested the efficacy of a nurse-delivered intervention in maintaining smoking abstinence after delivery among pregnant women who quit smoking that was tailored on their high risk of relapse (eg, had strong intentions to return). METHODS: We recruited 382 English-speaking spontaneous pregnant quitters from 14 prenatal clinics and randomized them to receive either a smoking abstinence booklet plus newsletters about parenting and stress (control) or a nurse-delivered smoking abstinence intervention that differed in intensity for the high and low risk groups. Our primary outcome was smoking abstinence at 12 months postpartum. RESULTS: Using intent-to-treat analyses, there was a high rate of biochemically validated smoking abstinence at 12 months postpartum but no arm differences ( CONTROL: 36% [95% confidence interval [CI]: 29-43] vs. INTERVENTION: 35% [95% CI: 28-43], P = .81). Among women at low risk of returning to smoking, the crude abstinence rate was significantly higher in the control arm (46%) than in the intervention arm (33%); among women at high risk of returning to smoking, the crude abstinence rate was slightly lower but not different in the control arm (31%) than in the intervention arm (37%). CONCLUSIONS: Low-risk women fared better with a minimal intervention that focused on parenting skills and stress than when they received an intensive smoking abstinence intervention. The opposite was true for women who were at high risk of returning to smoking. Clinicians might need to tailor their approach based on whether women are at high or low risk of returning to smoking. IMPLICATIONS: Results suggest that high-risk and low-risk women might benefit from different types of smoking relapse interventions. Those who are lower risk of returning to smoking might benefit from stress reduction that is devoid of smoking content, whereas those who are higher risk might benefit from smoking relapse prevention.

Predictors of adverse events among pregnant smokers exposed in a nicotine replacement therapy trial.

OBJECTIVE: The purpose of this study was to determine the contribution of randomization to nicotine replacement therapy (NRT), sociodemographic and psychosocial factors, and pregnancy and medical history to serious perinatal adverse events among pregnant smokers. STUDY DESIGN: We performed a retrospective review of all medical records for participants in the Baby Steps Trial. Data that were abstracted from 157 records were combined with baseline characteristics for logistic regression modeling of serious adverse events and adjusted for covariates. RESULTS: Serious adverse events occurred in 17% (9/52 pregnancies) and 31% (33/105 pregnancies) of participants in the control and NRT arms, respectively. Black race, adverse pregnancy history, and use of analgesic medication during pregnancy were significant predictors (P = .02, .04, and .01, respectively). Remaining covariates, which included randomization to NRT, were not statistically significant. CONCLUSION: Although race, poor pregnancy history, and use of analgesics were associated with serious adverse events, randomization to NRT during pregnancy was not a significant factor. Further research is needed to examine the safety of analgesic medications during pregnancy.

Adherence to nicotine replacement therapy among pregnant smokers.

INTRODUCTION: This secondary analysis examined the association between adherence to nicotine replacement therapy (NRT) and smoking cessation among pregnant smokers enrolled in Baby Steps, an open-label randomized controlled trial testing cognitive-behavioral therapy (CBT) versus CBT plus NRT. METHOD: The analysis included only women who received NRT for whom we had complete data (N = 104). Data came from daily calendars created from recordings of counseling sessions and from telephone surveys at baseline and 38 weeks gestation. RESULTS: Overall, 29% of the 104 women used NRT for the recommended 6 weeks and 41% used NRT as directed in the first 48 hr after a quit attempt. Ordinal logistic regression modeling indicated that using NRT as directed in the first 48 hr and having made a previous quit attempt were the strongest predictors of longer NRT use. Univariate analyses suggested that primigravid women and women who used NRT longer were more likely to report quitting at 38 weeks gestation. DISCUSSION: Findings indicated that adherence to NRT is low among pregnant smokers, but adherence was a predictor of cessation. Future trials should emphasize adherence, particularly more days on NRT, to promote cessation during pregnancy.

Olfactory and gustatory sensory changes to tobacco smoke in pregnant smokers.

Models of smoking behavior change include addiction, social, and behavioral concepts. The purpose of this study was to explore the prevalence of two biologic factors, olfactory and gustatory responses to tobacco smoke, as potentially powerful contributors to smoking behavior change among pregnant women. Data were obtained from 209 pregnant smokers. The majority of women reported olfactory (62%) and gustatory (53%) aversions to tobacco. Aversions first appeared during the first trimester of pregnancy. Women who experienced olfactory aversions were more likely also to experience gustatory aversions. Olfactory aversions were associated with women smoking less. Aversions to tobacco smoke are common among pregnant smokers, are associated with women smoking less, and could help explain pregnant women's smoking patterns.

Nicotine replacement and behavioral therapy for smoking cessation in pregnancy.

BACKGROUND: This study examines whether adding nicotine replacement therapy (NRT) to cognitive-behavioral therapy (CBT) for pregnant smokers increases rates of smoking cessation. METHODS: An open-label randomized trial (Baby Steps, n=181) of CBT-only versus CBT+NRT (choice of patch, gum, or lozenge; 1:2 randomization) was used. Data were collected from 2003 through 2005; analyses were conducted in 2006 and 2007. Outcomes were biochemically validated self-reported smoking status at 7 weeks post-randomization, 38 weeks gestation, and 3 months postpartum. RESULTS: Women in the CBT+NRT arm were almost three times more likely than women in the CBT-only arm to have biochemically validated cessation at both pregnancy time points (after 7 weeks: 24% vs 8%, p=0.02; at 38 weeks gestation: 18% vs 7%, p=0.04), but not at 3 months postpartum (20% vs 14%, p=0.55). Recruitment was suspended early by an Independent Data and Safety Monitoring Board when an interim analysis found a higher rate of negative birth outcomes in the CBT+NRT arm than in the CBT-only arm. In the final analysis, the difference between the arms in rate of negative birth outcomes was 0.09 (p=0.26), when adjusted for previous history of preterm birth. CONCLUSIONS: The addition of NRT to CBT promoted smoking cessation in pregnant women. This effect did not persist postpartum. More data are needed to determine safety parameters and to confirm the efficacy of NRT use during pregnancy.

Challenges and solutions for recruiting pregnant smokers into a nicotine replacement therapy trial.

Improvements in smoking cessation interventions for pregnant smokers are needed. One major step is to examine the potential effectiveness of nicotine replacement therapy (NRT). The potential benefits of providing pregnant women with NRT to help them quit smoking are still unknown; early interventions to test the effectiveness and efficacy are vital to advancing the field. This paper describes recruitment efforts for a multiclinic trial to test the effectiveness of NRT use in addition to behavioral therapy in promoting cessation during pregnancy. The biggest challenge is recruiting sufficient numbers of pregnant women. This paper discusses specific obstacles for recruitment and solutions. Knowing the potential pitfalls to recruiting pregnant women into these trials can lead to better studies and thus improved outcomes.

A model for postpartum smoking resumption prevention for women who stop smoking while pregnant.

Behavior change models and theories have been useful in our efforts to help people stop smoking. However, models that were developed for the general population do not always fit special populations such as pregnant women. Many women stop smoking while pregnant, but most resume smoking after giving birth. To help women who stop smoking while pregnant to stay smoke-free, a model for tailoring a smoking resumption-prevention intervention to the special needs of pregnant and postpartum women is proposed. The intervention begins during pregnancy, continues postpartum, and addresses pregnancy and parenting contextual factors in women's lives. The model is based on motivational theory and includes conducting patient assessments, developing risk profiles, triaging women to different levels of intervention intensity, and matching intervention strategies to women's risk profiles.

Why do women stop smoking during pregnancy? Cigarettes taste and smell bad.

There are high rates of cigarette smoking resumption among women who have quit smoking while pregnant, and the reasons for this are poorly understood. Our purpose in this study was to obtain an in-depth description of the context surrounding smoking behaviors during pregnancy and the first 3 months after women give birth in order to gain insight into the reasons women resume smoking. We used a longitudinal qualitative descriptive approach with in-depth interviews conducted early in pregnancy, at 36 weeks of pregnancy, and 3 months postpartum. Our purposive sample consisted of 15 pregnant women who had stopped smoking without assistance by their first prenatal visit. All women smoked mentholated cigarettes prior to pregnancy and 40% were primiparas. A thematic content analysis of 43 interviews revealed that the majority of women experienced an aversion to the taste or smell of tobacco smoke while pregnant and attributed these sensation changes to being pregnant. The taste and smell of tobacco smoke returned to prepregnancy states postpartum, and by 3 months postpartum 73% of the women had resumed smoking. This physiologic change can be conceptualized as a pregnancy-specific motivation for smoking cessation that can inform our efforts toward relapse prevention.

Context and beliefs about smoking and smoking cessation.

PURPOSE: To describe the context of, and beliefs about, smoking cessation in a sample of low-income African American pregnant women. STUDY DESIGN & METHODS: A naturalistic descriptive qualitative approach was used with 15 women. Face-to-face interviews were conducted using a semi-structured interview guide. Interviews were transcribed verbatim and a thematic content analysis conducted. Perinatal health complication data were extracted from the participants' medical records and summarized. RESULTS: Two major themes were identified. The context of smoking cessation theme was Living the Stressful Life, with subthemes of Personal and Community Stress, Personal Health Problems, and Smoking For Stress Management. The second major theme was Personal Accountability for Smoking Cessation. There was a mismatch between women's sources of stress (which were out of their control) and their perceived locus of change (which was personal behavior). CLINICAL IMPLICATIONS: To improve the outcomes of tobacco control programs for low-income women, we need to take action to create healthier communities.

Informed consent and the history of inclusion of women in clinical research.

The purposes of this paper are to (a) discuss the troubled history of informed consent for research on women and its ramifications for women's participation in clinical trials; (b) interrogate current informed consent practices as to their accountability and justice in the treatment of women; and (c) recommend to nurse researchers and clinical nurses ways of improving the practice of informed consent in research with women.

Reduction of primary and secondary smoke exposure for low-income black pregnant women.

Cigarette smoking by women during pregnancy continues to be a substantial contributor to poor perinatal outcomes in the United States. Decreasing tobacco smoke exposure for women and children is a lifestyle change that will improve perinatal health. A study was conducted with a sample of 74 low-income black women to evaluate the effectiveness of the Smoke Free Families intervention in moving pregnant women forward in the stages of change toward becoming a non-smoker and reducing exposure to second-hand smoke. Transtheoretical model variables were measured at intake, postintervention, and during the last month of pregnancy. There were no statistically significant differences between treatment and control group in movement forward in the stages of change. The findings raise questions about the conceptual fit of the transtheoretical model with pregnant women. We discuss additional interventions and suggest types of studies that would provide new insight into tobacco exposure issues for pregnant women.

Ethical issues of informed consent: mothers' experiences enrolling their children in bone marrow transplantation research.

Twelve mothers whose children had undergone bone marrow transplantation were interviewed about their experiences giving informed consent. They were asked to describe how they were introduced to bone marrow transplantation as a course of action to treat their gravely ill children, what their understanding of the protocol was, and the process by which they gave their consent. Their stories reveal complex ethical issues that may surface in the course of informed consent for research involving children. Findings suggest that mothers perceive life-and-death circumstances when a child is offered bone marrow transplantation, altering the voluntary nature of the research enterprise. The emotional trauma of the diagnosis decreases a mother's ability to absorb and understand vital information, and the emergent nature of the children's condition and the urgency to begin treatment further compromise informed consent by constricting the time and resources mothers may need to make a decision. Once a protocol is underway, mothers often experience regrets and self-recriminations about their decision to consent. Recommendations are offered that expand upon the current cognitive/rational approach to informed consent and take into account emotional experiences and the importance of building relationships to ensure informed consent over the life of a clinical trial.

Smoke free families: a tobacco control program for pregnant women and their families.

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.