condition 4 for Tobacco

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tobacco
Referral to SmokeFreeMoms, Quitline or Brief intervention - Behavioral
Eligibility
18 - 65
Female
What conditions do you have?
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Study Summary

Tobacco smoking in pregnancy remains one of the most important and preventable cause of adverse pregnancy outcomes. Data from National Survey of Drug Use and Health (NSDUH) suggests, that the annual average rates of current cigarette use among women aged 15 to 44 who were not pregnant decreased from 30.7 percent in 2002-2003 to 24.0 percent in 2012-2013. However, the prevalence of cigarette use among pregnant women in this age range did not change significantly during the same time period (18.0 percent in 2002-2003 and 15.4 percent in 2012-2013)Smoking cigarettes during pregnancy and nursing causes considerable health damage to the fetus and to the infant during the initial growth phase. An estimated 19.8 million women in the United States smoke. Nationally, 23 percent of women report smoking in the 3 months before pregnancy, while 13 percent report smoking in the last 3 months of pregnancy. Overwhelming evidence suggests that maternal smoking during pregnancy is associated with an adverse pregnancy outcomes including IUGR, placenta previa, abruption placentae, preterm premature rupture of membranes, low birth weight, perinatal mortality, intrapartum stillbirth and ectopic pregnancy. Moreover, prenatal exposure to tobacco smoke also increases risk of attention deficit and hyperactivity disorder (ADHD) and sudden infant death syndrome (SIDS) in the offspring.Children born to mothers who smoke during pregnancy are at increased risk of asthma, infantile colic, and childhood obesity. Brief interventions are shown to be associated with small but clear increases in smoking cessation in pregnancy, but are rarely used. Technology may fill this void. For the present study, pregnant women reporting smoking during pregnancy will be recruited and randomly assigned to one of eight combinations of three technology-delivered intervention approaches: Brief intervention, Quitline referral, and "SmokeFreeMoms" text messages (http://women.smokefree.gov/smokefreemom.aspx).

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Seven-day point-prevalence

Seven-day point-prevalence
Abstinence from smoking

Trial Safety

Safety Progress

1 of 3

Trial Design

8 Treatment Groups

Control group
1 of 8
condition 4
1 of 8
condition 2
1 of 8
condition 6
1 of 8
condition 7
1 of 8
condition 5
1 of 8
condition 3
1 of 8
condition 8
1 of 8
Active Control
Experimental Treatment

200 Total Participants · 8 Treatment Groups

Primary Treatment: condition 4 · No Placebo Group · N/A

condition 4
Behavioral
Experimental Group · 1 Intervention: Referral to SmokeFreeMoms, Quitline or Brief intervention · Intervention Types: Behavioral
condition 2
Behavioral
Experimental Group · 1 Intervention: Referral to SmokeFreeMoms, Quitline or Brief intervention · Intervention Types: Behavioral
condition 6
Behavioral
Experimental Group · 1 Intervention: Referral to SmokeFreeMoms, Quitline or Brief intervention · Intervention Types: Behavioral
condition 7
Behavioral
Experimental Group · 1 Intervention: Referral to SmokeFreeMoms, Quitline or Brief intervention · Intervention Types: Behavioral
condition 5
Behavioral
Experimental Group · 1 Intervention: Referral to SmokeFreeMoms, Quitline or Brief intervention · Intervention Types: Behavioral
condition 3
Behavioral
Experimental Group · 1 Intervention: Referral to SmokeFreeMoms, Quitline or Brief intervention · Intervention Types: Behavioral
condition 8
Behavioral
Experimental Group · 1 Intervention: Referral to SmokeFreeMoms, Quitline or Brief intervention · Intervention Types: Behavioral
Control groupNoIntervention Group · 1 Intervention: Control group · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: seven-day point-prevalence

Who is running the clinical trial?

Wayne State UniversityLead Sponsor
286 Previous Clinical Trials
103,977 Total Patients Enrolled
Robert Sokol, MDStudy DirectorWSU

Eligibility Criteria

Age 18 - 65 · Female Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: October 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References