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Introduction: Smoking during pregnancy can affect infant birthweight. We tested whether an intervention that promoted scheduled gradual reduction improved birth outcomes among pregnant women who smoked. We also examined race differences in birth outcomes., Methods: We conducted a 2-arm randomized controlled trial where pregnant women who smoked received either SMS text-delivered scheduled gradual smoking reduction (SGR) program plus support texts or support messages only throughout their pregnancy. The outcomes for this paper were birth outcomes including birth weight and gestational age obtained from chart review. Analyses were conducted using chi-square and t-tests in SAS., Results: We approached 2201 pregnant women with smoking history. Of the 314 women recruited into the study, 290 completed a medical release form (92%). We did not find any significant differences in birth outcomes by arm or race. The majority of participants reduced smoking by the 80%. Women who reduced more than 50% of their baseline cigarettes per day had a birth weight increase of 335 g compared to those that did not (p = 0.05). The presence of alcohol/drug use in prenatal visit notes was associated with low infant birth weight (p = 0.05)., Discussion: The scheduled gradual reduction intervention did not improve birth outcomes. Additional research is needed to help improve birth outcomes for pregnant women who engage in tobacco and illicit substance use. CLINICAL TRIAL #: NCT01995097., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: The purpose of this paper was to examine changes in situational temptations to smoke among women in early to late pregnancy enrolled in a texting trial to help them quit smoking. We compared changes between (1) intervention arms, (2) those who quit, (3) those who reduced by 50% or more, and (4) those who reduced by less than 50%. We also examined cravings overtime in the intervention arm and the relationship between real-time cravings assessed via text message and situational temptations., Methods: This was a secondary analysis of the Baby Steps trial, a randomized controlled trial testing the efficacy of a text-based scheduled gradual reduction (SGR) intervention on cessation. We used t-tests to examine changes across intervention arms and repeated measured proc mixed to explore changes in situational temptations and cravings., Results: Among all women, situational temptations decreased from early to late pregnancy for the positive, negative, and habitual subscales, (ps < 0.001). We found no difference in situational temptations across arms. We found a positive relationship between negative situational temptation and average craving during the Weeks 2 and Weeks 3 of the intervention. Negative ST increased by 0.11 for each unit increase of craving at Week 2., Conclusions: As women progress through pregnancy their temptation to smoke reduces. A different relationship might exist, however with negative affect situations in which women reported higher craving but not in response to other temptations. Future work might have a particular focus on the intersection of negative affect with cravings and temptations to promote cessation during pregnancy., Clinical Trial: NCT01995097., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Light smoking (smoking ≤ 10 cigarettes per day or on some days) has become increasingly prevalent in the US and increases morbidity and mortality. Many light smokers do not experience significant nicotine withdrawal but instead smoke in response to cues. Minimal evidence exists supporting interventions to help light smokers quit smoking., Methods: We present results from a proof-of-concept pilot study designed to evaluate the feasibility and acceptability of a cue-based smoking cessation intervention targeted to light daily and intermittent smokers. Participants were randomized to one of two arms: Arm 1) standard smoking cessation treatment or Arm 2) standard smoking cessation treatment + enhanced cue-based treatment that included interactive texting to extend cue exposure treatment to real-world settings and cue management counseling.Outcomes included feasibility (number of participants who were recruited and who completed the intervention), acceptability (intervention ratings), and preliminary efficacy (7-day point prevalence abstinence)., Results: We randomized 24 English and Spanish-speaking light smokers, 13 to the treatment arm and 11 to the control arm. Across both arms, 77% attended all counseling sessions, 90% rated these sessions as very useful and 100% said that they would recommend the intervention to a friend. 15% in the treatment arm had biochemically-validated smoking abstinence compared to 0% in the standard counseling arm., Conclusions: Results from this proof-of-concept study demonstrated that a cue-based intervention is feasible and acceptable among light smokers and suggests the need for a fully powered study to assess this approach., Trial Registration: This study is registered at www.clinicaltrials.gov NCT03416621., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Introduction: Smokeless tobacco (ST) use significantly affects morbidity and mortality and remains disproportionally prevalent in rural and medically underserved communities. Few programs exist for rural smokeless tobacco users. Text-based interventions may increase the reach of cessation interventions; yet, none has tested them in ST users. We evaluated the feasibility, acceptability, and preliminary efficacy of a text-based Scheduled Gradual Reduction (SGR) intervention in rural and underserved ST users., Methods: ST users were randomized in 2:1 fashion to the SGR group (N = 65), a text-based reduction program plus text-based support counseling messages or text-based support messages only group (N = 33). We surveyed participants at 30-days post intervention initiation to assess feasibility and acceptability and examined self-report 7-day point prevalence cessation at 30-days and 6-months post intervention initiation in the two arms., Results: We achieved benchmarks for feasibility and acceptability. Among the SGR participants 51% (n = 48) reported that intervention was useful in helping them quit, 83% (n = 48) indicated that they would recommend the intervention to a friend. Over 95% (n = 39) of SGR participants said that they read all alert texts. The SGR participants had a higher quit rate at 30-days compared to support messages alone (SGR = 21.5%, Control = 9.1%, p = 0.1627, Cohen's d equivalent = 0.56, medium effect). However, the quit rate at 6-months was 21% (p = 0.9703) for both groups., Conclusions: A text-based intervention was feasible and acceptable among underserved ST users. SGR helped promote short-term cessation. The text-based interventions both had long-term efficacy. Given that text-based interventions have the potential to increase reach in underserved ST users, further testing is warranted., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Introduction: Smoking during pregnancy poses serious risks to baby and mother. Few disseminable programs exist to help pregnant women quit or reduce their smoking. We hypothesized that an SMS text-delivered scheduled gradual reduction (SGR) program plus support texts would outperform SMS support messages alone., Methods: We recruited 314 pregnant women from 14 prenatal clinics. Half of the women received theory-based support messages throughout their pregnancy to promote cessation and prevent relapse. The other half received the support messages plus alert texts that gradually reduced their smoking more than 3-5 weeks. We conducted surveys at baseline, end of pregnancy, and 3 months postpartum. Our primary outcome was biochemically validated 7-day point prevalence abstinence at late pregnancy. Our secondary outcome was reduction in cigarettes per day., Results: Adherence to the SGR was adequate with 70% responding to alert texts to smoke within 60 minutes. Women in both arms quit smoking at the same rate (9%-12%). Women also significantly reduced their smoking from baseline to the end of pregnancy from nine cigarettes to four; we found no arm differences in reduction., Conclusions: Support text messages alone produced significant quit rates above naturally occurring quitting. SGR did not add significantly to helping women quit or reduce. Sending support messages can reach many women and is low-cost. More obstetric providers might consider having patients who smoke sign up for free texting programs to help them quit., Implications: A disseminable texting program helped some pregnant women quit smoking.Clinical Trial Registration number: NCT01995097., (© The Author(s) 2019. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: Most pregnant women know that smoking poses serious risks to baby and mother, yet many still smoke. We conducted a large randomized controlled trial and found that an SMS text-delivered program helped about 10% of these women quit smoking. In this paper, we describe the feasibility of disseminating a text-based intervention to pregnant women who smoke., Methods: We tested dissemination in two ways from prenatal clinics and compared recruitment rates to those found in our large randomized controlled trial. The first method involved "direct texting" where study staff identified women who smoked and sent them a text asking them to text back if they wanted to receive texts to help them quit. The second involved "nurse screening" where clinic staff from county health departments screened women for smoking and asked them to send a text to the system if they wanted to learn more about the program. Our primary outcome was feasibility assessed by the number of women who texted back their baby's due date, which served as "enrolling" in the texting program, which we compared to the recruitment rate we found in our large trial., Results: Over 4 months, we texted 91 women from the academic health system. Of those, 17 texted back and were counted as "enrolled." In the health departments, across the 4 months, 12 women texted the system initially. Of those, 10 were enrolled. This rate was similar to the rate enrolled in the randomized controlled trial., Discussion: Two different methods connected pregnant women who smoke to a texting program. One of these methods can be automated further and have the potential of helping many women quit smoking with minimal effort. Clinical Trial # NCT01995097.

Purpose: Many cancer survivors continue to smoke. Further, most survivors also report high levels of persistent pain and smoke in response to pain. The investigators tested the feasibility, acceptability, and preliminary efficacy of a smoking cessation program paired with a pain management program for cancer survivors., Methods: The investigators conducted a two-arm, wait-list randomized controlled pilot study in which they delivered a combined smoking cessation and pain management intervention., Results: The investigators randomized 30 survivors (14 intervention and 16 wait-list control). Seventy-one percent of the survivors who received the intervention rated it as extremely useful (5 out of 5) in helping them quit smoking. Further, 86% would recommend the program to other survivors. Although we could not conduct inferential statistics, 14% of those in the intervention arm, compared to 6% in the control condition had biochemically validated cessation at 2-months post-randomization. Survivors in the intervention also reported less pain, had improvements in depressive symptoms, and better physical function than those in the control arm., Conclusions: Our pilot data suggest the feasibility, acceptability, and preliminary efficacy of this approach. The next step is to conduct a large randomized controlled trial to fully test the efficacy of the intervention., Implications for Cancer Survivors: A combined smoking cessation and pain program might help improve both issues simultaneously.

Text-based interventions are effective for smoking cessation, but have not been tested in rural older adults. The purpose of this study was to compare the feasibility, acceptability and preliminary efficacy of a text-based Scheduled Gradual Reduction (SGR) program to a non-SGR text messaging support condition among rural older adults. Adults over 60 years were randomized to either: (i) the SGR program (n = 20), a text-based program to reduce smoking over 4-weeks plus text-based support messages; or (ii) control (n = 20), receipt of text-based support messages only. Participants completed surveys at baseline and end of program to assess feasibility and acceptability of the intervention, and biochemically validated 7-day point prevalence cessation was assessed at end of treatment. Most participants (81%) reported reading all the messages they received. Participants found both interventions useful in quitting smoking (SGR = 57%, Control = 63%) and would recommend it to a friend (SGR = 72%, Control = 79%). Although not statically significant, the SGR group had a higher rate of biochemically validated cessation (SGR = 15%, Control = 5%, Cohen d = 0.67). Among those still smoking, the median percent reduction in cigarettes was 33.3% for both groups. Text-based cessation interventions are feasible, acceptable and can be easily disseminated to rural older adult tobacco users.

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., (© The Author 2016. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Context: Prior cross-sectional studies have reported greater pain intensity among persistent smokers compared with nonsmokers or former smokers; yet, few prospective studies have examined how smoking abstinence affects pain intensity., Objectives: To determine the impact of smoking cessation on subsequent pain intensity in smokers with chronic illness enrolled in a smoking cessation trial., Methods: We recruited veteran smokers with chronic illness (heart disease, cancer, chronic obstructive pulmonary disease, diabetes, or hypertension) for a randomized controlled smoking cessation trial and prospectively examined pain intensity and smoking status. Participants (n = 380) were asked to rate their pain in the past week from 0 to 10 at baseline and the five-month follow-up. The primary outcome measure was self-reported pain intensity at the five-month follow-up survey. Self-reported smoking status was categorized as an abstainer if patients reported no cigarettes in the seven days before the follow-up survey., Results: In unadjusted analyses, abstainers reported significantly lower pain levels at the five-month follow-up compared with patients who continued to smoke (parameter estimate = -1.07; 95% CI = -1.77, -0.36). In multivariable modeling, abstaining from cigarettes was not associated with subsequent pain intensity at five-month follow-up (parameter estimate = -0.27; 95% CI = -0.79, 0.25)., Conclusion: Participants who were classified as abstainers did not report significantly different levels of pain intensity than patients who continued to smoke. Future studies should expand on our findings and monitor pain intensity in smoking cessation trials., Trial Registration: ClinicalTrials.govNCT00448344., (Published by Elsevier Inc.)

Introduction: Although many pregnant women quit smoking, most return to smoking postpartum. Returning to smoking is strongly related to women's stated intention about smoking during pregnancy. We examined factors related to women's intention to return to smoking to improve intervention trials., Methods: We report cross-sectional baseline data from a randomized controlled trial to prevent postpartum return to smoking. Women (n = 382; 98% consent rate) were English-speaking women who smoked at least 100 cigarettes in their lifetimes and at least 5 cigarettes a day prior to becoming pregnant. We fit logistic regression models to test whether women's intention to return to smoking was associated with demographic and smoking factors such as race, parity, and smoker self-identity., Results: Forty-three percent of women had a strong intention of returning to smoking. Factors independently associated with intending to return to smoking were: stating they did not want to be currently pregnant (OR = 2.1, CI = 1.1-3.9), reporting being abstinent for fewer days (OR = 0.8, CI = 0.7-0.9), being less concerned about the harmful effects of smoking to themselves (OR = 1.6, CI = 0.9-2.8), viewing quit as temporary (OR = 2.1, CI = 1.2-3.6), and self-identifying selves as smokers (OR = 8.7, CI = 5.0-15.2)., Conclusions: Although some factors related to intention to return to smoking were unchangeable, it might be possible to attempt to change women's attribution of why they quit to be more permanent and to have them change their self-identity to be a "nonsmoker" from a "smoker who is not currently smoking." Helping women have stronger intentions to stay quit could promote less return to smoking postpartum., (© The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: An increasing proportion of daily smokers are light smokers (≤10 cigarettes per day). Some light smokers have never smoked more than 10 cigarettes per day (native light smokers) and others smoked at higher levels but have cut down (converted light smokers). It is important that we expand our understanding of these distinct subgroups of light smokers in order to develop effective interventions., Methods: Data for this report come from a larger sample of smokers who completed a cross-sectional survey administered through an online panel survey service. The sample of 522 light smokers included 256 native light smokers and 266 as converted light smokers. The goal of the analysis was to examine demographic, smoking, and psychosocial factors that differentiate between native and converted light smokers., Results: Multivariable logistic regression results showed 4 variables that differentiated between native and converted light smokers. Native light smokers were more likely to be Black than White, smoke fewer cigarettes per day, smoked fewer total years, and had higher perceived risk of heart disease than converted light smokers., Conclusions: Native and converted light smokers are similar in many ways and also differ on some important characteristics. Further exploration of group difference is needed and could help to inform for cessation strategies for daily light smokers., (© The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Although many Latinos in the United States smoke, they receive assistance to quit less often than non-Latinos. To address this disparity, we recruited Latino couples into a randomized controlled trial and provided a smoking cessation program during a teachable moment, when men's partners were pregnant., Methods: We compared two interventions: (i) written materials plus nicotine replacement therapy (NRT) to (ii) materials, NRT, and couple-based counseling that addressed smoking cessation and couples communication. We recruited 348 expectant fathers who smoked via their pregnant partners from county health departments. Our primary outcome was 7-day point prevalence smoking abstinence and was collected from November 2010 through April 2013 and analyzed in February 2014., Results: We found high rates of cessation but no arm differences in smoking rates at the end of pregnancy (0.31 vs. 0.30, materials only vs. counseling, respectively) and 12 months after randomization (postpartum: 0.39 vs. 0.38). We found high quit rates among nondaily smokers but no arm differences (0.43 vs. 0.46 in pregnancy and 0.52 vs. 0.48 postpartum). Among daily smokers, we found lower quit rates with no arm differences but effects favoring the intervention arm (0.13 vs. 0.16 in pregnancy and 0.17 vs. 0.24 postpartum)., Conclusions: A less intensive intervention promoted cessation equal to more intensive counseling. Postpartum might be a more powerful time to promote cessation among Latino men., Impact: Less intensive interventions when delivered during teachable moments for Latino men could result in a high smoking cessation rate and could reduce disparities., (©2014 American Association for Cancer Research.)

Introduction: Smoking during pregnancy causes multiple perinatal complications; yet, the smoking rate among pregnant women has remained relatively stagnant. Most interventions to help pregnant smokers quit or reduce their smoking are not easily disseminable. Innovative and disseminable interventions are needed., Methods: We recruited 31 pregnant smokers in their second trimester from prenatal clinics. We assessed feasibility, acceptability, and preliminary efficacy of an SMS text-based intervention in a 2-arm design. We compared SMS-delivered support messages to an intervention that provided support messages plus a scheduled gradual reduction (SGR) to help women reduce their smoking more than 3 weeks. We sent women in the SGR arm "alert texts" at times to instruct them to smoke. We asked women not to smoke unless they received an alert text., Results: Most women (86%) reported reading most or all of the texts. Women in both arms rated the program as helpful (M = 6, SD = 1 vs. M = 5, SD = 2, SGR vs. support only, respectively). Women in the SGR arm had a higher rate of biochemically validated 7-day point prevalence at the end of pregnancy 13.4% versus 7.5%. Of those still smoking, women reduced their smoking substantially with more reduction in the SGR arm (SGR arm: M = 16, SD = 11 vs. support messages only: M = 12, SD = 7)., Conclusions: We developed an easily disseminable intervention that could possibly promote cessation and reduction among pregnant women with SMS texting ability. Women in this pilot were enthusiastic about the program, particularly those in the SGR arm. This program needs further examination.

Purpose: When a patient is diagnosed with lung cancer, members of his/her social network may be more likely to engage in smoking cessation efforts. Proactive telephone counseling combined with a tailored self-directed intervention may be more effective at promoting smoking cessation than a tailored self-directed intervention alone., Design: Randomized controlled trial., Setting: Four clinical sites., Subjects: Current smokers who are family members and close friends of patients with lung cancer., Intervention: Six counselor-initiated counseling calls using motivational interviewing techniques and focusing on teaching adaptive coping skills based on the transactional model of stress and coping along with tailored self-directed materials (including nicotine patches, if not contraindicated) (n  =  245) vs. tailored self-directed materials (including nicotine patches, if not contraindicated) (n  =  251)., Measures: Participants were surveyed at baseline and at 2 weeks, 6 months, and 12 months postintervention. The outcome was 7-day point prevalent abstinence., Analysis: The objective of this study was to test for arm differences in smoking cessation rates at 2 weeks and 6 months postintervention (primary) and at 12 months postintervention (secondary)., Results: We found no overall effect of the proactive intervention on cessation rates. Among younger participants (age <50), the cessation rate in the intervention group was higher than in the control group at 2 weeks postintervention (16% vs. 4%, p  =  .046). For older participants (age >50), there were no group differences., Conclusion: Proactive telephone counseling focusing on adaptive coping skills was difficult to implement among smokers in lung cancer patients' social network. Although this study did not demonstrate any added benefit to cessation rates, this null finding may be a result of an intervention that was weaker than intended, owing to difficulties in completing the counseling phone calls. We discuss lessons learned and areas for future research in this special population.

Objective: To examine demographic, relationship, and smoking history factors related to expected positive and negative support for quitting smoking among chronically ill veterans., Methods: Data for this report comes from baseline data from a randomized controlled trial of a support-based smoking cessation intervention for veterans with chronic diseases (cancer, cardiovascular disease, hypertension, diabetes, and chronic obstructive pulmonary disease). We used separate multiple linear regression models to analyze relationships between positive and negative support and variables selected for model entry., Results: Veterans in our sample expected high positive and negative support for quitting. Veterans who were married/living as married, had some college education, were female, or named a female support person expected higher levels of positive support. Veterans who named a female or a nonsmoker as a support person expected higher levels of negative support. Males and non-Caucasians also reported higher levels of expected negative support., Conclusions: Individual differences that influence perceptions of expected support are likely to influence intervention participation and engagement. Thus, understanding factors associated with expected positive and negative support is necessary to optimize future implementation of support-based cessation interventions through better treatment matching., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Background: This report describes the characteristics associated with successful enrollment of smokers in the social networks (i.e., family and close friends) of patients with lung cancer into a smoking cessation intervention., Methods: Lung cancer patients from four clinical sites were asked to complete a survey enumerating their family members and close friends who smoke, and provide permission to contact these potential participants. Family members and close friends identified as smokers were interviewed and offered participation in a smoking cessation intervention. Repeated measures logistic regression model examined characteristics associated with enrollment., Results: A total of 1062 eligible lung cancer patients were identified and 516 patients consented and completed the survey. These patients identified 1325 potentially eligible family and close friends. Of these, 496 consented and enrolled in the smoking cessation program. Network enrollment was highest among patients who were white and had late-stage disease. Social network members enrolled were most likely to be female, a birth family, immediate family, or close friend, and live in close geographic proximity to the patient., Conclusions: Proactive recruitment of smokers in the social networks of lung cancer patients is challenging. In this study, the majority of family members and friends declined to participate. Enlisting immediate female family members and friends, who live close to the patient as agents to proactively recruit other network members into smoking cessation trials could be used to extend reach of cessation interventions to patients' social networks. Moreover, further consideration should be given to the appropriate timing of approaching network smokers to consider cessation., (Published by Elsevier Inc.)

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.

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.