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| Name | Class |
|---|---|
| Tulane University | OTHER |
| Centers for Disease Control and Prevention | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| No implementation of the intervention | No Intervention | Standard in-service activities |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training in smoking cessation counseling | Behavioral | 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 |
| 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 |
| 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 |
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Inclusion Criteria por prenatal clinics:
Exclusion Criteria for prenatal clinics:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Althabe, MD | Institute for Clinical Effectiveness and Health Policy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Lucio Meléndez | Adrogué | Buenos Aires | Argentina | |||
| Hospital Evita Pueblo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23971512 | Derived | 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. |
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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 |
| Berazategui |
| Buenos Aires |
| Argentina |
| Hospital M.V de Martínez | General Pacheco | Buenos Aires | Argentina |
| Hospital Narciso López | Lanus | Buenos Aires | Argentina |
| Hospital Héroes de Malvinas | Merlo | Buenos Aires | Argentina |
| Hospital Municipal Ostaciana B. de Lavignolle | Morón | Buenos Aires | Argentina |
| Hospital Materno Infantil de San Isidro | San Isidro | Buenos Aires | Argentina |
| Hospital Bocalandro | Tres de Febrero | Buenos Aires | Argentina |
| Hospital Maternidad Santa Rosa | Vicente López | Buenos Aires | Argentina |
| Hospital San Roque | Manuel B. Gonnet | La Plata | Argentina |
| Centro de Salud Badano Repetto | Montevideo | Montevideo Department | Uruguay |
| Centro de Salud Cerro | Montevideo | Montevideo Department | Uruguay |
| Centro de Salud Misurraco | Montevideo | Montevideo Department | Uruguay |
| Centro de Salud Saint Bois | Montevideo | Montevideo Department | Uruguay |
| Centro Materno Infantil 1 | Montevideo | Montevideo Department | Uruguay |
| Centro Materno Infantil 2 | Montevideo | Montevideo Department | Uruguay |
| Centro Materno Infantil 3 | Montevideo | Montevideo Department | Uruguay |
| Centro Materno Infantil 4 | Montevideo | Montevideo Department | Uruguay |
| Centro Materno Infantil 5 | Montevideo | Montevideo Department | Uruguay |
| Centro Materno Infantil 6 | Montevideo | Montevideo Department | Uruguay |
| Hospital Canzani | Montevideo | Montevideo Department | Uruguay |
| Hospital Pereira Rossell | Montevideo | Montevideo Department | Uruguay |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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