A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6858 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-08-31

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.

Detailed Description

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Conditions

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Smoking Cessation Pregnancy

Keywords

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Smoking Cessation Pregnancy Implementation Knowledge translation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Training in smoking cessation counseling

Intervention Type 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

No implementation of the intervention

Standard in-service activities

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* None

Minimum Eligible Age

12 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Ezequiel Garcia Elorrio

Chief of Administration

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fernando Althabe, MD

Role: PRINCIPAL_INVESTIGATOR

Institute for Clinical Effectiveness and Health Policy

Locations

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Hospital Lucio Meléndez

Adrogué, Buenos Aires, Argentina

Site Status

Hospital Evita Pueblo

Berazategui, Buenos Aires, Argentina

Site Status

Hospital M.V de Martínez

General Pacheco, Buenos Aires, Argentina

Site Status

Hospital Narciso López

Lanús, Buenos Aires, Argentina

Site Status

Hospital Héroes de Malvinas

Merlo, Buenos Aires, Argentina

Site Status

Hospital Municipal Ostaciana B. de Lavignolle

Morón, Buenos Aires, Argentina

Site Status

Hospital Materno Infantil de San Isidro

San Isidro, Buenos Aires, Argentina

Site Status

Hospital Bocalandro

Tres de Febrero, Buenos Aires, Argentina

Site Status

Hospital Maternidad Santa Rosa

Vicente López, Buenos Aires, Argentina

Site Status