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A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

This study has been completed.
Sponsor:
Collaborators:
Tulane University
Information provided by (Responsible Party):
Ezequiel Garcia Elorrio, Institute for Clinical Effectiveness and Health Policy
ClinicalTrials.gov Identifier:
NCT01852617
First received: June 22, 2011
Last updated: January 29, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
Smoking Cessation
Pregnancy
Behavioral: Training in smoking cessation counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

Resource links provided by NLM:


Further study details as provided by Institute for Clinical Effectiveness and Health Policy:

Primary Outcome Measures:
  • Frequency of women receiving the cessation smoking advice [ Time Frame: Interviews during the first 12 hours after delivery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Frequency of women who smoke at the end of pregnancy [ Time Frame: Interviews and saliva samples during the first 12 hours after delivery ] [ Designated as safety issue: No ]
    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.

  • Frequency of providers' positives attitudes and readiness to change [ Time Frame: 6 months before and after the implementation of the intervention ] [ Designated as safety issue: No ]
    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.


Enrollment: 6858
Study Start Date: October 2011
Study Completion Date: August 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implementation of intervention
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
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 Intervention: No implementation of the intervention
Standard in-service activities

  Eligibility

Ages Eligible for Study:   12 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852617

Locations
Argentina
Hospital Bocalandro
Tres de Febrero, Buenos Aires Province, Argentina
Hospital Lucio Meléndez
Adrogué, Buenos Aires, Argentina
Hospital Evita Pueblo
Berazategui, Buenos Aires, Argentina
Hospital M.V de Martínez
General Pacheco, Buenos Aires, Argentina
Hospital Narciso López
Lanús, 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 Maternidad Santa Rosa
Vicente López, Buenos Aires, Argentina
Hospital San Roque
Gonnet, La Plata, Argentina
Uruguay
Centro de Salud Misurraco
Montevideo, Uruguay
Centro de Salud Cerro
Montevideo, Uruguay
Hospital Pereira Rossell
Montevideo, Uruguay
Centro de Salud Saint Bois
Montevideo, Uruguay
Centro Materno Infantil 1
Montevideo, Uruguay
Centro Materno Infantil 2
Montevideo, Uruguay
Centro Materno Infantil 3
Montevideo, Uruguay
Centro Materno Infantil 4
Montevideo, Uruguay
Centro Materno Infantil 5
Montevideo, Uruguay
Centro Materno Infantil 6
Montevideo, Uruguay
Hospital Canzani
Montevideo, Uruguay
Centro de Salud Badano Repetto
Montevideo, Uruguay
Sponsors and Collaborators
Institute for Clinical Effectiveness and Health Policy
Tulane University
Investigators
Principal Investigator: Fernando Althabe, MD Institute for Clinical Effectiveness and Health Policy
  More Information

No publications provided by Institute for Clinical Effectiveness and Health Policy

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ezequiel Garcia Elorrio, Chief of Administration, Institute for Clinical Effectiveness and Health Policy
ClinicalTrials.gov Identifier: NCT01852617     History of Changes
Other Study ID Numbers: 1U48DP001948-01
Study First Received: June 22, 2011
Last Updated: January 29, 2015
Health Authority: United States: Institutional Review Board
United States: Centers for Disease Control and Prevention
Argentina: Institutional Review Board
Argentina: Institute for Clinical Effectiveness and Health Policy
Uruguay: Comite de Etica

Keywords provided by Institute for Clinical Effectiveness and Health Policy:
Smoking Cessation
Pregnancy
Implementation
Knowledge translation

ClinicalTrials.gov processed this record on March 03, 2015