Interventions of Smoking Cessation During Pregnancy

Smoking Cessation Clinical Trial

Official title:

The Effectiveness of High and Low Intensity Intervention for Smoking Cessation During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210118
• Other study ID #: PBAL001
• Status: Completed
• Phase: Phase 1
• First received: September 23, 2010
• Last updated: April 7, 2013
• Start date: November 2009
• Est. completion date: February 2012

Study information

• 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

Clinical Trial Summary

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.

Description:

This is a randomized controlled trial that compares the efficacy of a proactive pregnancy-tailored high intensity intervention for smoking cessation, with a usual care low intensity intervention, that is the control condition.

Intervention group participants will receive a high intensity intervention, which includes:

30 minutes of cognitive-behavioural intervention delivered by a trained health care professional through out the first 24 weeks of gestation and a self-help manual especially tailored for smoking cessation during pregnancy. Control group participants will receive 5 minutes of low intensity intervention.

Participants' smoking status will be biochemically validated with urine cotinine and nicotine both at the baseline and at the 32nd week of gestation, expired carbon monoxide (CO) will be measured only at the baseline. After childbirth the infants' birth weight, the premature birth and any other complications in pregnancy and childbirth will be recorded. No medication is going to be used.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Low intensity intervention
Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
• Higher intensity intervention
Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the "5 ?s" (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided.

Locations

Country	Name	City	State
Greece	Peripheral General Hospital-Maternity Helena Venizelos	Athens	Attiki
Greece	Maternity Unit of ATTIKON University Hospital	Haidari	Attiki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Anticancer Society	National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (3)

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).

Outcome

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

External Links

•   MedlinePlus related topics: Pregnancy, Smoking Cessation