Pregnancy Clinical Trial
The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a “best practice” control condition.
Status | Completed |
Enrollment | 434 |
Est. completion date | June 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Pregnant women - current cigarette smoker (smoked >1 cigarette in the past 7 days) - 18 years old or older - Willing to consider altering their smoking behavior during their pregnancy Exclusion Criteria: - More than 26 weeks' gestation at study entry - No telephone access - Not planning to live in New England for 1 year - Unable to read and speak English |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Tufts Health Plan | Waltham | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Robert Wood Johnson Foundation |
United States,
Rigotti NA, Park ER, Regan S, Chang Y, Perry K, Loudin B, Quinn V. Efficacy of telephone counseling for pregnant smokers: a randomized controlled trial. Obstet Gynecol. 2006 Jul;108(1):83-92. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy | |||
Secondary | Biochemically-validated 7-day point prevalence tobacco abstinence at 3 months postpartum | |||
Secondary | Self-reported significant (>50%) reduction in tobacco use | |||
Secondary | Quit attempt of >24 hours duration from enrollment to end of pregnancy |
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