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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Smoking Cessation
Interventions Behavioral: Low intensity intervention
Behavioral: Higher intensity intervention
Enrollment 92
Recruitment Details This research took place in two hospitals situated in the area of Attici, Greece namely through the Peripheral General Maternity Hospital ‘Helena Venizelos’ and the Maternity Unit of the ‘Attikon’ University Hospital. Recruitment lasted from November 2009- February 2011.
Pre-assignment Details Sixty-six enrolled participants were excluded from the trial before assignment to groups because 36 of them did not meet the inclusion criteria and 30 of them refused to participate.
Arm/Group Title High Intensity Intervention Low Intensity Intervention
Hide Arm/Group Description Experimental group participants received a higher intensity intervention, which included: 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. 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.
Period Title: Overall Study
Started 45 47
Completed 42 42
Not Completed 3 5
Reason Not Completed
Lost to Follow-up             1             1
Protocol Violation             1             1
Spontaneous abortion             1             3
Arm/Group Title High Intensity Intervention Low Intensity Intervention Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 42 42 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
 100.0%
42
 100.0%
84
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 84 participants
31.4  (5.9) 32.4  (4.5) 31.9  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Female
42
 100.0%
42
 100.0%
84
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Greece Number Analyzed 42 participants 42 participants 84 participants
42 42 84
1.Primary Outcome
Title Participants' Smoking Status
Hide Description participants' smoking status was validated by urine cotinine and urine nicotine
Time Frame around the 32nd week of gestation.
Hide Outcome Measure Data
Hide Analysis Population Description
Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis
Arm/Group Title High Intensity Intervention Low Intensity Intervention
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 42
Mean (Standard Deviation)
Unit of Measure: ng/ml
Urine nicotine 253.6  (532.3) 678.9  (1467.2)
Urine cotinine 311.9  (490.1) 479.6  (563.4)
2.Primary Outcome
Title The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.
Hide Description 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.
Time Frame At the baseline and at the 32nd week of gestation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Intensity Intervention Low Intensity Intervention
Hide Arm/Group Description:
Experimental group participants received a higher intensity intervention, which included: 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.
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.
Overall Number of Participants Analyzed 42 42
Measure Type: Number
Unit of Measure: percentage of participants who quit
Before Intervention (baseline) 11.9 21.4
After intervention (32nd week of gestation) 45.2 21.4
3.Secondary Outcome
Title Birth Weight
Hide Description Infants' birth weight was recorded.
Time Frame After child birth
Hide Outcome Measure Data
Hide Analysis Population Description
Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.
Arm/Group Title High Intensity Intervention Low Intensity Intervention
Hide Arm/Group Description:
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
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.
Overall Number of Participants Analyzed 42 42
Mean (Standard Deviation)
Unit of Measure: birth weight in grams
3,003.4  (499.8) 3,231.3  (450.8)
4.Secondary Outcome
Title Days of Prematurity of Birth
Hide Description Days of prematurity of birth were recorded
Time Frame After child birth
Hide Outcome Measure Data
Hide Analysis Population Description
Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.
Arm/Group Title High Intensity Intervention Low Intensity Intervention
Hide Arm/Group Description:
Experimental group participants received a higher intensity intervention, which included: 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
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.
Overall Number of Participants Analyzed 42 42
Mean (Standard Deviation)
Unit of Measure: number of days
14.3  (11.6) 10.5  (6.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Intensity Intervention Low Intensity Intervention
Hide Arm/Group Description 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. 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.
All-Cause Mortality
High Intensity Intervention Low Intensity Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
High Intensity Intervention Low Intensity Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/42 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Intensity Intervention Low Intensity Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/42 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Professor Panagiotis Behrakis
Organization: Hellenic Anticancer Society
Phone: 00302106470056
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).
Responsible Party: PANAGIOTIS BEHRAKIS, Hellenic Anticancer Society
ClinicalTrials.gov Identifier: NCT01210118     History of Changes
Other Study ID Numbers: PBAL001
First Submitted: September 23, 2010
First Posted: September 28, 2010
Results First Submitted: January 23, 2013
Results First Posted: April 9, 2013
Last Update Posted: April 9, 2013