Brief 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).

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

200

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 months study duration

Study Start

First participant enrolled

January 1, 2015

Completed

12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed

Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

3 months

First QC Date

January 13, 2015

Last Update Submit

January 15, 2015

Conditions

Tobacco Use Cessation

Outcome Measures

Primary Outcomes (1)

Abstinence from smoking
To compare the effects on smoking of an online brief intervention to those of referral to a free online text messaging intervention, and to those of free phone counseling through the Michigan Quitline.
Seven-day point-prevalence

Study Arms (8)

Control group

NO INTERVENTION

No intervention(control group)