Smoking Cessation Clinical Trial
Official title:
The Effectiveness of High and Low Intensity Intervention for Smoking Cessation During Pregnancy
Verified date | April 2013 |
Source | Hellenic Anticancer Society |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ministry of Health and Welfare |
Study type | Interventional |
The aim of this clinical trial is to test whether offering pregnant smokers a high intensity intervention for smoking cessation increases the rate of smoking cessation at the third trimester of pregnancy, compared to low intensity intervention for smoking cessation that is the usual care, control condition.
Status | Completed |
Enrollment | 92 |
Est. completion date | February 2012 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Pregnant women - current cigarette smoker (smoked >5 cigarettes in the past 7 days) - 18 years old or older Exclusion Criteria: - More than 24 weeks' gestation at study entry - No telephone access - Not planning to live in Athens for 1 year - Unable to read and speak Greek - Alcoholics - Use of drug substances - Depression |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Greece | Peripheral General Hospital-Maternity Helena Venizelos | Athens | Attiki |
Greece | Maternity Unit of ATTIKON University Hospital | Haidari | Attiki |
Lead Sponsor | Collaborator |
---|---|
Hellenic Anticancer Society | National and Kapodistrian University of Athens |
Greece,
Loukopoulou A N, Evangelopoulou V, Behrakis P K.Smoking and pregnancy. Pneumon 23(2):160-167,2010.
Loukopoulou AN, Vardavas CI, Farmakides G, Rossolymos C, Chrelias C, Tzatzarakis MN, Tsatsakis A, Lymberi M, Connolly GN, Behrakis PK. Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE). BMC Public Health. 2011 Dec 6;11:903. doi: 10.1186/1471-2458-11-903. — View Citation
Loukopoulou AN, Vasiliou MP, Behrakis PK. (2011) Interventions for smoking cessation during Pregnancy Pneumon, 24(1):381-391(Review).
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants' Smoking Status | participants' smoking status was validated by urine cotinine and urine nicotine | around the 32nd week of gestation. | No |
Primary | The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. | The basic primary outcomes of the study present the levels of urine cotinine before and after intervention separately for each group according to the cut of point that is used for the separation of active from passive smoking ,when urine cotinine =80ng/ml: there is biochemically validated smoking cessation. | At the baseline and at the 32nd week of gestation | No |
Secondary | Birth Weight | Infants' birth weight was recorded. | After child birth | No |
Secondary | Days of Prematurity of Birth | Days of prematurity of birth were recorded | After child birth | No |
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