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| Name | Class |
|---|---|
| National and Kapodistrian University of Athens | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High intensity intervention | Experimental | 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 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity intervention | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Panagiotis K Behrakis, Professor | National and Kapodistrian University of Athens | Study Chair |
| Andriani N Loukopoulou, PhD pending | National and Kapodistrian University of Athens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peripheral General Hospital-Maternity Helena Venizelos | Athens | Attica | Greece | |||
| Maternity Unit of ATTIKON University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Loukopoulou A N, Evangelopoulou V, Behrakis P K.Smoking and pregnancy. Pneumon 23(2):160-167,2010. | ||
| Background | Loukopoulou AN, Vasiliou MP, Behrakis PK. (2011) Interventions for smoking cessation during Pregnancy Pneumon, 24(1):381-391(Review). | ||
| 22145828 | Background | 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. | |
| 33537575 |
| Label | URL |
|---|---|
| MedlinePlus related topics: Pregnancy, Smoking Cessation | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants' Smoking Status | participants' smoking status was validated by urine cotinine and urine nicotine | Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis | Posted | Mean | Standard Deviation | ng/ml | around the 32nd week of gestation. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Panagiotis Behrakis | Hellenic Anticancer Society | 00302106470056 | pbehraki@hsph.harvard.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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|
| Higher intensity intervention | Behavioral | 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. |
|
|
| After child birth |
| Haidari |
| Attica |
| 12462 |
| Greece |
| Derived |
| 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. |
| Spontaneous abortion |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | Birth Weight | Infants' birth weight was recorded. | Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis. | Posted | Mean | Standard Deviation | birth weight in grams | After child birth |
|
|
|
| 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. | Posted | Number | percentage of participants who quit | At the baseline and at the 32nd week of gestation |
|
|
|
| Secondary | Days of Prematurity of Birth | Days of prematurity of birth were recorded | Only the participants who met the inclusion criteria and completed the research protocol were included in the research analysis. | Posted | Mean | Standard Deviation | number of days | After child birth |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | 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. | 0 | 42 | 0 | 42 |
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