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Interventions of Smoking Cessation During Pregnancy

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ClinicalTrials.gov Identifier: NCT01210118
Recruitment Status : Completed
First Posted : September 28, 2010
Results First Posted : April 9, 2013
Last Update Posted : April 9, 2013
Sponsor:
Collaborator:
National and Kapodistrian University of Athens
Information provided by (Responsible Party):
PANAGIOTIS BEHRAKIS, Hellenic Anticancer Society

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Low intensity intervention Behavioral: Higher intensity intervention Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effectiveness of High and Low Intensity Intervention for Smoking Cessation During Pregnancy
Study Start Date : November 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


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 Name: Experimental group

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.




Primary Outcome Measures :
  1. Participants' Smoking Status [ Time Frame: around the 32nd week of gestation. ]
    participants' smoking status was validated by urine cotinine and urine nicotine

  2. The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention. [ Time Frame: At the baseline and at the 32nd week of gestation ]
    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.


Secondary Outcome Measures :
  1. Birth Weight [ Time Frame: After child birth ]
    Infants' birth weight was recorded.

  2. Days of Prematurity of Birth [ Time Frame: After child birth ]
    Days of prematurity of birth were recorded



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210118


Locations
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Greece
Peripheral General Hospital-Maternity Helena Venizelos
Athens, Attiki, Greece
Maternity Unit of ATTIKON University Hospital
Haidari, Attiki, Greece, 12462
Sponsors and Collaborators
Hellenic Anticancer Society
National and Kapodistrian University of Athens
Investigators
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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

Additional Information:
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).

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Responsible Party: PANAGIOTIS BEHRAKIS, PROFESSOR OF NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS., Hellenic Anticancer Society
ClinicalTrials.gov Identifier: NCT01210118     History of Changes
Other Study ID Numbers: PBAL001
First Posted: September 28, 2010    Key Record Dates
Results First Posted: April 9, 2013
Last Update Posted: April 9, 2013
Last Verified: April 2013

Keywords provided by PANAGIOTIS BEHRAKIS, Hellenic Anticancer Society:
Pregnancy
Smoking cessation
Cognitive-Behavioural interventions