Status:
COMPLETED
Preventing Postpartum Return to Smoking
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Smoking
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
STUDY PURPOSE: Aim 1. To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy. Aim 2. To determine the associa...
Detailed Description
STUDY DESIGN: A two-arm randomized controlled trial will be conducted. Women's risk for resumption will be assessed at 4 time-points. 1. Between 28 and 34 weeks of pregnancy 2. 6-weeks postpartum 3....
Eligibility Criteria
Inclusion
- 18 years of age or older
- Speak English
- Registered for prenatal care
- Have a history of smoking (defined as having smoked at least 100 cigarettes in their lifetimes and at least 5 cigarettes a day prior to becoming pregnant)
- Will need to have been continuously abstinent from tobacco for at least 1 month prior to their risk assessment
- Women will be eligible if they stopped smoking upon learning of their pregnancies and have been continuously abstinent (self-initiated quitters), or if they continued to smoke during the first few months of pregnancy but have been continuously abstinent from 24 to 28 weeks.
Exclusion
- Any women who stopped smoking and resumed by the 34-week risk assessment will be ineligible.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT00917943
Start Date
April 1 2008
End Date
December 1 2012
Last Update
April 10 2013
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27705