A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

Study Overview
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Brief Summary
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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.

Official Title
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A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

Conditions
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Smoking Cessation, Pregnancy

Intervention / Treatment
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* Behavioral: Training in smoking cessation counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria por prenatal clinics: 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. Exclusion Criteria for prenatal clinics: None

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation of intervention<br>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 | Behavioral: Training in smoking cessation counseling<br>* 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<br>|
| No Intervention: No implementation of the intervention<br>Standard in-service activities | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Interviews during the first 12 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6 months before and after the implementation of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Pregnancy, Implementation, Knowledge translation