Smoking CessationNCT01852617
A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay
A study testing Training in smoking cessation counseling in people with Smoking Cessation and Pregnancy, run by Institute for Clinical Effectiveness and Health Policy at 22 sites in 2 countries.
Trial summary
Argentina and Uruguay are among the countries with the highest proportion of pregnant women who smoke. The implementation of an effective smoking cessation intervention would have a significant impact on the health of mothers and children. Read more about this study
- Who is it for?
- Ages 12 to 49 years, women only
- Conditions the study is for
- Smoking Cessation, Pregnancy
- What is being tested?
- Training in smoking cessation counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,858 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Oct 2011to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Not having a smoking cessation program based on the "5 A's" for pregnant women in place.
- An estimated frequency of women receiving the "5 A's" intervention below 20%
- Having midwives or nurse-midwives as part of the hospital or primary health center staff.
- Having signed a letter of intention to participate in the project.
- Having at least 400 new pregnant women per year.
Who cannot join
- None
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
Uruguay12 sites
Centro de Salud Badano Repetto
Montevideo, Montevideo Department
Centro de Salud Cerro
Montevideo, Montevideo Department
Centro de Salud Misurraco
Montevideo, Montevideo Department
Centro de Salud Saint Bois
Montevideo, Montevideo Department
Centro Materno Infantil 1
Montevideo, Montevideo Department
Centro Materno Infantil 2
Montevideo, Montevideo Department
Centro Materno Infantil 3
Montevideo, Montevideo Department
Centro Materno Infantil 4
Montevideo, Montevideo Department
Centro Materno Infantil 5
Montevideo, Montevideo Department
Centro Materno Infantil 6
Montevideo, Montevideo Department
Hospital Canzani
Montevideo, Montevideo Department
Hospital Pereira Rossell
Montevideo, Montevideo Department
Argentina10 sites
Hospital Lucio Meléndez
Adrogué, Buenos Aires
Hospital Evita Pueblo
Berazategui, Buenos Aires
Hospital M.V de Martínez
General Pacheco, Buenos Aires
Hospital Narciso López
Lanus, Buenos Aires
Hospital San Roque
Manuel B. Gonnet, La Plata
Hospital Héroes de Malvinas
Merlo, Buenos Aires
Hospital Municipal Ostaciana B. de Lavignolle
Morón, Buenos Aires
Hospital Materno Infantil de San Isidro
San Isidro, Buenos Aires
Hospital Bocalandro
Tres de Febrero, Buenos Aires
Hospital Maternidad Santa Rosa
Vicente López, Buenos Aires
About this study
Argentina and Uruguay are among the countries with the highest proportion of pregnant women who smoke. The implementation of an effective smoking cessation intervention would have a significant impact on the health of mothers and children. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide. However, it is under used in Argentina and Uruguay. We will conduct a two-arm, parallel cluster randomized controlled trial of an implementation intervention in 20 prenatal clinics in Argentina and Uruguay. Our primary hypothesis is that the intervention is feasible in prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving tobacco use cessation counseling during pregnancy. Our secondary hypothesis is that the intervention will decrease the frequency of women who smoke by the end of their pregnancies. Prenatal clinics will be randomly allocated to either an intervention or a control group after a baseline data collection period. Midwife facilitators in the ten intervention clinics will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The ten clinics in the control group will continue with their standard in-service activities. A follow-up data collection will be conducted immediately after delivery. The intervention will be tailored by formative research to be readily applicable to local prenatal care services at busy maternity hospitals, as well as to be acceptable to local pregnant women and health providers. The study will be conducted in 48 months.
- Conditions
- Smoking Cessation, Pregnancy
- Being tested
- Training in smoking cessation counseling
- Keywords
- Smoking Cessation, Pregnancy, Implementation, Knowledge translation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training in smoking cessation counselingBehavioural
Midwife facilitators in the intervention clinics will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide
| Study group | Role | What they receive |
|---|---|---|
| Implementation of intervention | Experimental | Midwife facilitators in the intervention clinics will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide Receives: Behavioral: Training in smoking cessation counseling |
| No implementation of the intervention | No intervention | Standard in-service activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of women receiving the cessation smoking advice
Frequency of women receiving the "5 A's" (ask smoking status of all women; advise smokers to quit; assess their willingness to make a quit attempt; assist their attempt by providing skills and materials for tobacco cessation; arrange: monitor smoking status at all prenatal visits) in women having prenatal care at the participating prenatal clinics.
Measured: Interviews during the first 12 hours after delivery
Secondary outcomes (2)
Frequency of women who smoke at the end of pregnancy
Frequency of women who smoke at the end of pregnancy: Women will be interviewed during their postpartum hospital stay and saliva samples will be taken for cotinine analysis.
Measured: Interviews and saliva samples during the first 12 hours after delivery
Frequency of providers' positives attitudes and readiness to change
Frequency of positives attitudes and readiness to provide counseling for smoking cessation to women following the "5 A's" model among midwives working at participating prenatal clinics. Assessed through a self-administered questionnaire.
Measured: 6 months before and after the implementation of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startOct 2011
- Primary completionNov 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,858 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Effectiveness and Health Policy
- Sponsor type
- University, hospital or other
- Collaborators
- Tulane University, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Ezequiel Garcia Elorrio, Institute for Clinical Effectiveness and Health Policy
- Investigators
- Fernando Althabe, MD, Principal investigator, Institute for Clinical Effectiveness and Health Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852617
- Sponsor's protocol ID
- 1U48DP001948-01
- Status last verified
- Jan 2015
- First submitted
- 22 Jun 2011
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Althabe F, Aleman A, Mazzoni A, Berrueta M, Morello P, Colomar M, Ciganda A, Becu A, Gibbons L, Llambi L, Bittar Gonzalez MG, Tong VT, Farr SL, Smith RA, Dietz PM, Johnson C, Buekens P, Belizan JM. Tobacco cessation intervention for pregnant women in Argentina and Uruguay: study protocol. Reprod Health. 2013 Aug 26;10(1):44. doi: 10.1186/1742-4755-10-44.
PubMed 23971512
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay
- ClinicalTrials.gov ID
- NCT01852617
- Acronym / sponsor ID
- 1U48DP001948-01
- Conditions
- Smoking Cessation, Pregnancy
- Keywords
- Smoking Cessation, Pregnancy, Implementation, Knowledge translation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,858 participants (actual)
- Lead sponsor
- Institute for Clinical Effectiveness and Health PolicyUniversity, hospital or other
- Collaborators
- Tulane University, Centers for Disease Control and Prevention
- Study start
- Oct 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Argentina and Uruguay are among the countries with the highest proportion of pregnant women who smoke. The implementation of an effective smoking cessation intervention would have a significant impact on the health of mothers and children. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide. However, it is under used in Argentina and Uruguay. We will conduct a two-arm, parallel cluster randomized controlled trial of an implementation intervention in 20 prenatal clinics in Argentina and Uruguay. Our primary hypothesis is that the intervention is feasible in prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving tobacco use cessation counseling during pregnancy. Our secondary hypothesis is that the intervention will decrease the frequency of women who smoke by the end of their pregnancies. Prenatal clinics will be randomly allocated to either an intervention or a control group after a baseline data collection period. Midwife facilitators in the ten intervention clinics will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The ten clinics in the control group will continue with their standard in-service activities. A follow-up data collection will be conducted immediately after delivery. The intervention will be tailored by formative research to be readily applicable to local prenatal care services at busy maternity hospitals, as well as to be acceptable to local pregnant women and health providers. The study will be conducted in 48 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation of intervention | Experimental | Behavioral: Training in smoking cessation counselingMidwife facilitators in the intervention clinics will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide |
| No implementation of the intervention | No intervention | –Standard in-service activities |
Who may qualify
- Ages
- 12 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Not having a smoking cessation program based on the "5 A's" for pregnant women in place.
- An estimated frequency of women receiving the "5 A's" intervention below 20%
- Having midwives or nurse-midwives as part of the hospital or primary health center staff.
- Having signed a letter of intention to participate in the project.
- Having at least 400 new pregnant women per year.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training in smoking cessation counselingMidwife facilitators in the intervention clinics will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide | Behavioural | Implementation of intervention |
Primary outcome
Frequency of women receiving the cessation smoking advice
Time frame: Interviews during the first 12 hours after delivery
Frequency of women receiving the "5 A's" (ask smoking status of all women; advise smokers to quit; assess their willingness to make a quit attempt; assist their attempt by providing skills and materials for tobacco cessation; arrange: monitor smoking status at all prenatal visits) in women having prenatal care at the participating prenatal clinics.
2 secondary outcomes
Frequency of women who smoke at the end of pregnancy
Time frame: Interviews and saliva samples during the first 12 hours after delivery
Frequency of providers' positives attitudes and readiness to change
Time frame: 6 months before and after the implementation of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
- Derived from this study: PubMed 23971512Althabe F, Aleman A, Mazzoni A, Berrueta M, Morello P, Colomar M, Ciganda A, Becu A, Gibbons L, Llambi L, Bittar Gonzalez MG, Tong VT, Farr SL, Smith RA, Dietz PM, Johnson C, Buekens P, Belizan JM. Tobacco cessation intervention for pregnant women in Argentina and Uruguay: study protocol. Reprod Health. 2013 Aug 26;10(1):44. doi: 10.1186/1742-4755-10-44.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Althabe, MD principal investigator
Institute for Clinical Effectiveness and Health Policy
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in smoking cessation counseling in people with Smoking Cessation and Pregnancy, run by Institute for Clinical Effectiveness and Health Policy at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Uruguay, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of women receiving the cessation smoking advice (time frame: Interviews during the first 12 hours after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01852617, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2015.