Predictors of adverse events among pregnant smokers exposed in a nicotine replacement therapy trial.
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ABSTRACT: 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.
SUBMITTER: Swamy GK
PROVIDER: S-EPMC2755600 | biostudies-literature | 2009 Oct
REPOSITORIES: biostudies-literature
Publications
Predictors of adverse events among pregnant smokers exposed in a nicotine replacement therapy trial.
Swamy Geeta K GK Roelands Jennifer J JJ Peterson Bercedis L BL Fish Laura J LJ Oncken Cheryl A CA Pletsch Pamela K PK Myers Evan R ER Whitecar Paul W PW Pollak Kathryn I KI
American journal of obstetrics and gynecology 20090807 4
<h4>Objective</h4>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.<h4>Study design</h4>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 regressi ...[more]
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Project description:IntroductionThis 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.MethodThe 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.ResultsOverall, 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.DiscussionFindings 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.
| S-EPMC2671460 | biostudies-literature
Project description:We compared acceptability, adherence and efficacy of trans-dermal nicotine patches and cognitive behavioral therapy (Group 1) to cognitive behavioral therapy alone (Group 2) in minority pregnant smokers. This is a randomized controlled trial. 52 women were recruited during pregnancy with a mean gestational age 18.5 ± 5.0 weeks and followed through delivery. Randomization was by site and initial cotinine levels. Interventionists and interviewers were blinded to group assignment. Two different nicotine replacement therapy dosing regiments were administered according to the baseline salivary cotinine level. A process evaluation model summarized patient adherence. The main outcome measure was self-report of cessation since last visit, confirmed by exhaled carbon monoxide. Analyses of categorical and continuous measures were conducted as well as linear trend tests of salivary cotinine levels. Women lost to follow-up were considered treatment failures. Participants were on average 27.5 ± 5.4 years old, 81 % were single, 69 % unemployed and 96 % were Medicaid eligible. A process evaluation indicated patients in both groups were adherent to scheduled program procedures through Visit 4, but not for Visits 5 and 6. Confirmed quit rates were: at visit 3, 23 (Group 1) and 0 % (Group 2) (p = 0.02); at visits 4 and 5, no difference; at visit 6, 19 (Group 1) and 0 % (Group 2) (p = 0.05). Group 1 delivered infants with a mean gestational age of 39.4 weeks versus 38.4 weeks in Group 2 (p = 0.02). 73 % (52/71) of the eligible smokers agreed to participate and 65 % (17/26) of Group 1 completed the protocol (i.e. attended 6 visits). A comparison of Group 1 and 2 quit rates confirmed a non-significant difference.
| S-EPMC3679235 | biostudies-literature
Project description:BackgroundPregnant smokers may be offered nicotine replacement therapy (NRT) alongside behavioral support to assist with a quit attempt. Yet trials of NRT have found adherence to be low among pregnant women, and this has made it difficult to determine the efficacy of NRT. The aim of this study is to understand the experience of pregnant women who use NRT but discontinue this early or do not use the medication as recommended.MethodsSemi-structured telephone interviews were conducted with 14 pregnant smokers who had recently been prescribed NRT, but self-reported poor NRT adherence or discontinuing treatment prematurely. Data were transcribed and analyzed using inductive thematic analysisResultsThere were four main themes identified; expectations of NRT, experience of using NRT, safety concerns and experience of using e-cigarettes. Some women intentionally used NRT to substitute a proportion of their cigarette intake and smoked alongside. Most women smoked while using NRT. Women who underutilized NRT did so as they experienced side effects, or were concerned that using NRT instead of smoking could actually increase their nicotine exposure and potential for increased nicotine dependence or fetal harm. Most women spoke about the use of e-cigarettes as a smoking cessation method but only a few had actually experienced using them during pregnancy.ConclusionMany women underused NRT but simultaneously smoked. Challenging negative perceptions about NRT and educating women further about the risks of smoking may encourage them to use NRT products as recommended.ImplicationsThese findings add to the research surrounding the efficacy of NRT during pregnancy by providing insight into how pregnant women use NRT during a quit attempt and how this may influence adherence. It may assist health professionals to support pregnant smokers by increasing their understanding about the differing ways in which women use NRT and help them address concerns women may have about the safety of NRT.
| S-EPMC5942617 | biostudies-literature
Project description:Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT) has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered--do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required.A single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months). Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years) who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000). Eligible subjects interested in free NRT will be determined at baseline (N = 1,000) and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco) at 6-month follow-up as compared to subjects who do not receive nicotine patches at baseline.The findings from the proposed trial are timely and highly relevant as mailed distribution of NRT require considerable resources and there are limited public health dollars available to combat this substantial health concern. In addition, findings from this randomized controlled trial will inform the development of models to engage smokers to quit, incorporating proactive recruitment and the offer of evidence based treatment.ClinicalTrials.gov: NCT01429129.
| S-EPMC3198706 | biostudies-literature
Project description:Public health initiatives to distribute nicotine replacement therapy free of charge as a means of promoting smoking cessation are ongoing. Are there enough smokers interested in using nicotine replacement therapy to have a substantial impact on the prevalence of smoking if this aid were distributed free to all interested smokers? We conducted a telephone survey of 825 randomly selected daily smokers aged 18 years or older who had smoked at least 10 cigarettes per day at some point in their lives. Overall, 58.9% of the respondents said they would be interested in nicotine replacement therapy if it were offered for free. Of those interested, almost all (93.8%) said that they would use the nicotine replacement therapy to help them quit for good. There were differences in the levels of interest: smokers who intended to quit were more interested in using the nicotine replacement therapy than those who planned to reduce or maintain their smoking.
| S-EPMC2443226 | biostudies-literature
Project description:To estimate the safety and efficacy of treatment with 2-mg nicotine gum for smoking cessation during pregnancy.Pregnant women who smoked daily received individualized behavioral counseling and random assignment to a 6-week treatment with 2-mg nicotine gum or placebo followed by a 6-week taper period. Women who did not quit smoking were instructed to reduce the number of cigarettes smoked by substituting with gum. Measures of tobacco exposure were obtained throughout the study.Participants in the nicotine (n = 100) and placebo (n = 94) groups were comparable in age, race/ethnicity, and smoking history. Biochemically validated smoking-cessation rates were not significantly higher with nicotine gum compared with placebo (after 6 weeks of treatment: 13% compared with 9.6%, P=.45; at 32-34 weeks of gestation: 18% compared with 14.9%, P=.56). Using a completer analysis, nicotine gum significantly reduced the number of cigarettes smoked per day (nicotine gum: -5.7 [standard deviation (SD)=6.0]; placebo: -3.5 [SD=5.7], P=.035), and cotinine concentration (nicotine gum: -249 ng/mL [SD=397]; placebo: -112 ng/mL [SD=333]; P=.04). Birth weights were significantly greater with nicotine gum compared with placebo (3,287 g [SD=566] and 2,950 g [SD=653], respectively, P<.001). Gestational age was also greater with nicotine-replacement therapy than with placebo (38.9 weeks [SD=1.7] and 38.0 weeks [SD=3.3], respectively; P=.014).Although nicotine gum did not increase quit rates, use of nicotine gum increased birth weight and gestational age, two key parameters in predicting neonatal wellbeing.
| S-EPMC2630492 | biostudies-literature
Project description:Evidenced-based tobacco cessation treatments are underused, especially by socioeconomically disadvantaged smokers. This contributes to widening socioeconomic disparities in tobacco-related morbidity and mortality.The Offering Proactive Treatment Intervention trial tested the effects of a proactive outreach tobacco treatment intervention on population-level smoking abstinence and tobacco treatment use among a population-based sample of socioeconomically disadvantaged smokers. Current smokers (n=2406), regardless of interest in quitting, who were enrolled in the Minnesota Health Care Programs, the state's publicly funded healthcare programmes for low-income populations, were randomly assigned to proactive outreach or usual care. The intervention comprised proactive outreach (tailored mailings and telephone calls) and free cessation treatment (nicotine replacement therapy and intensive, telephone counselling). Usual care comprised access to a primary care physician, insurance coverage of Food and Drug Administration-approved smoking cessation medications, and the state's telephone quitline. The primary outcome was self-reported 6-month prolonged smoking abstinence at 1 year and was assessed by follow-up survey.The proactive intervention group had a higher prolonged abstinence rate at 1 year than usual care (16.5% vs 12.1%, OR 1.47, 95% CI 1.12 to 1.93). The effect of the proactive intervention on prolonged abstinence persisted in selection models accounting for non-response. In analysis of secondary outcomes, use of evidence-based tobacco cessation treatments were significantly greater among proactive outreach participants compared with usual care, particularly combination counselling and medications (17.4% vs 3.6%, OR 5.69, 95% CI 3.85 to 8.40).Population-based proactive tobacco treatment increases engagement in evidence-based treatment and is effective in long-term smoking cessation among socioeconomically disadvantaged smokers. Findings suggest that dissemination of population-based proactive treatment approaches is an effective strategy to reduce the prevalence of smoking and socioeconomic disparities in tobacco use.NCT01123967.
| S-EPMC4862067 | biostudies-other
Project description:BackgroundSmokers who are unwilling or unable to quit smoking may benefit from using nicotine replacement therapy (NRT) for harm reduction. This may include the partial or complete substitution of cigarettes with NRT. A taxonomy of the characteristics of those using NRT for harm reduction would be helpful in tailoring advice and treatment. Although attempts to categorize those using NRT for harm reduction have been made, these have largely been based on quantitative data. In order to provide further in-depth exploration of views, beliefs and experiences, the current study probed issues surrounding NRT and harm reduction qualitatively to better understand barriers and facilitators to this approach.MethodsThree groups of participants (n = 15) were recruited from a student sample: current smokers with a history of NRT use, smokers without a history of NRT use, and ex-smokers with a history of NRT use. Participants were asked about their demographic characteristics, smoking behaviours, intention and perceived ability to quit smoking, awareness and use of NRT, beliefs about the health consequences of using NRT, and the safety and efficacy of NRT, using semi-structured telephone interviews.ResultsTwenty-four themes were identified; these themes were clustered into three main issues of cross-cutting themes: attitudes towards smoking and motivation to quit; smoking reduction and quit attempts; and beliefs, use and concerns about NRT. Those with a history of NRT use were more motivated and engaged with the quitting process than non-users. However, irrespective of smoking status and past NRT use, all participants showed misperceptions about NRT, such as the health consequences associated with NRT use.ConclusionsNRT users are more motivated to quit smoking than non-users and are more likely to employ techniques to assist their cessation attempts. The majority of smokers have misperceptions regarding the safety and efficacy of NRT which may act as a barrier to its usage.
| S-EPMC4364650 | biostudies-literature
Project description:ObjectiveTo determine the efficacy of 16 hour nicotine patches among pregnant smokers, with the dose individually adjusted according to saliva cotinine levels (potential range 10-30 mg/day).DesignRandomised, double blind, placebo controlled, parallel group, multicentre trial (Study of Nicotine Patch in Pregnancy, SNIPP) between October 2007 and January 2013.Setting23 maternity wards in France.Participants476 pregnant smokers aged more than 18 years and between 12 and 20 weeks' gestation, who smoked at least five cigarettes a day. After exclusions, 402 women were randomised: 203 to nicotine patches and 199 to placebo patches. Data were available on 192 live births in each group.InterventionsNicotine and identical placebo patches were administered from quit day up to the time of delivery. Doses were adjusted to saliva cotinine levels when smoking to yield a substitution rate of 100%. Participants were assessed monthly and received behavioural smoking cessation support.Main outcome measuresThe primary outcomes were complete abstinence (self report confirmed by carbon monoxide level in expired air ≤ 8 ppm) from quit date to delivery, and birth weight. The secondary outcomes were point prevalence of abstinence, time to lapse (a few puffs) or relapse, and delivery and birth characteristics. All data were analysed on an intention to treat basis.ResultsComplete abstinence was achieved by 5.5% (n=11) of women in the nicotine patch group and 5.1% (n=10) in the placebo patch group (odds ratio 1.08, 95% confidence interval 0.45 to 2.60). The median time to the first cigarette smoked after target quit day was 15 days in both groups (interquartile range 13-18 in the nicotine patch group, 13-20 in the placebo patch group). The point prevalence abstinence ranged from 8% to 12.5% in the nicotine patch group and 8% to 9.5% in the placebo patch group without statistically significant differences. The nicotine substitution rate did not differ from 100%, and the self reported median compliance rate was 85% (interquartile range 56-99%) in the nicotine patch group and 83% (56-95%) in the placebo patch group, assessed at 1016 visits. The mean birth weight was 3065 g (SE 44 g) in the nicotine patch group and 3015 g (SE 44 g) in the placebo patch group (P=0.41). Diastolic blood pressure was significantly higher in the nicotine patch group than in the placebo patch group. The frequency of serious adverse events was similar between the groups, although more non-serious adverse reactions, mainly of skin, occurred in the nicotine patch group.ConclusionThe nicotine patch did not increase either smoking cessation rates or birth weights despite adjustment of nicotine dose to match levels attained when smoking, and higher than usual doses.Trial registrationClinicalTrials.gov NCT00507975.
| S-EPMC3950302 | biostudies-literature
Project description:BackgroundPrevious research suggests exposure to nicotine replacement therapy (NRT) may be associated with an increased risk of cardiovascular disease (CVD).MethodsUsing data from the United Kingdom's Clinical Practice Research Datalink, this study aimed to evaluate CVD events and survival among individuals who attempted smoking cessation with the support of NRT compared with those aided by smoking cessation advice only. We studied CVD outcomes over 4 and 52 weeks in 50,214 smokers attempting to quit - 33,476 supported by smoking cessation advice and 16,738 with the support of NRT prescribed by their primary care physician. Patients were matched (2 smoking cessation advice patients:1 NRT patient) on demographic and clinical characteristics during a baseline year preceding their quit attempt. Cox proportional hazard regression, conditional negative binomial regression model, and conditional logistic regression were used to analyze data.ResultsMean (standard deviation) population age was 47 (11.2) years; 51% were females. Time to first diagnosis of ischemic heart disease (IHD) among NRT and smoking cessation advice patients was similar within the first 4 weeks, but shorter for NRT patients over 52 weeks (hazard ratio [HR]: 1.35, 95% confidence interval [CI]: 1.03-1.77). A similar trend was observed for cerebrovascular disease (HR: 1.54, 95% CI: 1.08-2.19). NRT patients with a prior diagnosis of IHD or cerebrovascular disease had a higher rate of primary or secondary care consultations for IHD or cerebrovascular disease by 52 weeks (rate ratio: 1.50, 95% CI: 1.14-1.99). Patients prescribed NRT had a shorter survival time over 52 weeks, compared with those receiving advice only (HR: 1.39, 95% CI: 1.09-1.76).ConclusionOur findings suggest that treatment with NRT over 4 weeks does not appear to have an impact on cardiovascular risks. However, a longer follow-up period of 52 weeks resulted in an increase in cardiovascular events for patients prescribed NRT, compared with those receiving smoking cessation advice only.
| S-EPMC5413486 | biostudies-literature