A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

January 29, 2015 updated by: Ezequiel Garcia Elorrio, Institute for Clinical Effectiveness and Health Policy
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6858

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Adrogué, Buenos Aires, Argentina
        • Hospital Lucio Meléndez
      • Berazategui, Buenos Aires, Argentina
        • Hospital Evita Pueblo
      • General Pacheco, Buenos Aires, Argentina
        • Hospital M.V de Martínez
      • Lanús, Buenos Aires, Argentina
        • Hospital Narciso López
      • Merlo, Buenos Aires, Argentina
        • Hospital Héroes de Malvinas
      • Morón, Buenos Aires, Argentina
        • Hospital Municipal Ostaciana B. de Lavignolle
      • San Isidro, Buenos Aires, Argentina
        • Hospital Materno Infantil de San Isidro
      • Vicente López, Buenos Aires, Argentina
        • Hospital Maternidad Santa Rosa
    • Buenos Aires Province
      • Tres de Febrero, Buenos Aires Province, Argentina
        • Hospital Bocalandro
    • La Plata
      • Gonnet, La Plata, Argentina
        • Hospital San Roque
  • Uruguay
      • Montevideo, Uruguay
        • Centro de Salud Badano Repetto
      • Montevideo, Uruguay
        • Centro de Salud Cerro
      • Montevideo, Uruguay
        • Centro de Salud Misurraco
      • 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
        • Hospital Pereira Rossell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: Interviews and saliva samples during the first 12 hours after delivery
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
Time Frame: 6 months before and after the implementation of the intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical Effectiveness and Health Policy

Collaborators

Tulane University
Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Fernando Althabe, MD, Institute for Clinical Effectiveness and Health Policy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

May 9, 2013

First Posted (Estimate)

May 14, 2013

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 29, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1U48DP001948-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking Cessation

Clinical Trials on Training in smoking cessation counseling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe