Trial Outcomes & Findings for Interventions of Smoking Cessation During Pregnancy (NCT NCT01210118)
NCT ID: NCT01210118
Last Updated: 2013-04-09
Results Overview
participants' smoking status was validated by urine cotinine and urine nicotine
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
92 participants
Primary outcome timeframe
around the 32nd week of gestation.
Results posted on
2013-04-09
Participant Flow
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.
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.
Participant milestones
| Measure |
High Intensity Intervention
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
47
|
|
Overall Study
COMPLETED
|
42
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
High Intensity Intervention
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Spontaneous abortion
|
1
|
3
|
Baseline Characteristics
Interventions of Smoking Cessation During Pregnancy
Baseline characteristics by cohort
| Measure |
High Intensity Intervention
n=42 Participants
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.
|
Low Intensity Intervention
n=42 Participants
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
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age Continuous
|
31.4 years
STANDARD_DEVIATION 5.9 • n=93 Participants
|
32.4 years
STANDARD_DEVIATION 4.5 • n=4 Participants
|
31.9 years
STANDARD_DEVIATION 5.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Greece
|
42 participants
n=93 Participants
|
42 participants
n=4 Participants
|
84 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: around the 32nd week of gestation.Population: Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis
participants' smoking status was validated by urine cotinine and urine nicotine
Outcome measures
| Measure |
High Intensity Intervention
n=42 Participants
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.
|
Low Intensity Intervention
n=42 Participants
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.
|
|---|---|---|
|
Participants' Smoking Status
Urine nicotine
|
253.6 ng/ml
Standard Deviation 532.3
|
678.9 ng/ml
Standard Deviation 1467.2
|
|
Participants' Smoking Status
Urine cotinine
|
311.9 ng/ml
Standard Deviation 490.1
|
479.6 ng/ml
Standard Deviation 563.4
|
PRIMARY outcome
Timeframe: At the baseline and at the 32nd week of gestationThe 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.
Outcome measures
| Measure |
High Intensity Intervention
n=42 Participants
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.
|
Low Intensity Intervention
n=42 Participants
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.
|
|---|---|---|
|
The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.
Before Intervention (baseline)
|
11.9 percentage of participants who quit
Interval 0.001 to 0.001
|
21.4 percentage of participants who quit
Interval 0.001 to 1.0
|
|
The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.
After intervention (32nd week of gestation)
|
45.2 percentage of participants who quit
|
21.4 percentage of participants who quit
|
SECONDARY outcome
Timeframe: After child birthPopulation: Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.
Infants' birth weight was recorded.
Outcome measures
| Measure |
High Intensity Intervention
n=42 Participants
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.
|
Low Intensity Intervention
n=42 Participants
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.
|
|---|---|---|
|
Birth Weight
|
3,003.4 birth weight in grams
Standard Deviation 499.8
|
3,231.3 birth weight in grams
Standard Deviation 450.8
|
SECONDARY outcome
Timeframe: After child birthPopulation: Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis.
Days of prematurity of birth were recorded
Outcome measures
| Measure |
High Intensity Intervention
n=42 Participants
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.
|
Low Intensity Intervention
n=42 Participants
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.
|
|---|---|---|
|
Days of Prematurity of Birth
|
14.3 number of days
Standard Deviation 11.6
|
10.5 number of days
Standard Deviation 6.9
|
Adverse Events
High Intensity Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Intensity Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Panagiotis Behrakis
Hellenic Anticancer Society
Phone: 00302106470056
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place