Interventions of Smoking Cessation During Pregnancy

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Higher intensity intervention; Behavioral: Low intensity intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 1

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece
      • Peripheral General Hospital-Maternity Helena Venizelos
    • Haidari, Attiki, Greece, 12462
      • Maternity Unit of ATTIKON University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High 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 Αs" (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.	Behavioral: 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 Αs" (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.; Other Names: Experimental group
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' Smoking Status	participants' smoking status was validated by urine cotinine and urine nicotine	around the 32nd week of gestation.
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth Weight	Infants' birth weight was recorded.	After child birth
Days of Prematurity of Birth	Days of prematurity of birth were recorded	After child birth

Collaborators and Investigators

• Sponsor: Hellenic Anticancer Society
• Collaborators: National and Kapodistrian University of Athens
• Investigators: Study Chair: Panagiotis K Behrakis, Professor, National and Kapodistrian University of Athens; Principal Investigator: Andriani N Loukopoulou, PhD pending, National and Kapodistrian University of Athens

Publications and helpful links

General Publications

• Loukopoulou A N, Evangelopoulou V, Behrakis P K.Smoking and pregnancy. Pneumon 23(2):160-167,2010.
• Loukopoulou AN, Vasiliou MP, Behrakis PK. (2011) Interventions for smoking cessation during Pregnancy Pneumon, 24(1):381-391(Review).
• 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.
• Loukopoulou AN, Vardavas CI, Farmakides G, Rosolymos C, Chrelias C, Tzatzarakis M, Tsatsakis A, Myridakis A, Lyberi M, Behrakis PK. Counselling for smoking cessation during pregnancy reduces tobacco-specific nitrosamine (NNAL) concentrations: A randomized controlled trial. Eur J Midwifery. 2018 Nov 14;2:14. doi: 10.18332/ejm/99546. eCollection 2018.

Helpful Links

• MedlinePlus related topics: Pregnancy, Smoking Cessation

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: September 23, 2010
• First Submitted That Met QC Criteria: September 25, 2010
• First Posted (Estimate): September 28, 2010

Study Record Updates

• Last Update Posted (Estimate): April 9, 2013
• Last Update Submitted That Met QC Criteria: April 7, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Pregnancy; Smoking cessation; Cognitive-Behavioural interventions
• Other Study ID Numbers: PBAL001