Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

6,858

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach

2 countries

22 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

First Submitted

Initial submission to the registry

June 22, 2011

Completed

3 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed

1.6 years until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed

Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

2.1 years

First QC Date

June 22, 2011

Last Update Submit

January 29, 2015

Conditions

Smoking Cessation Pregnancy

Keywords

Smoking CessationPregnancyImplementationKnowledge translation

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

Frequency of women who smoke at the end of pregnancy
Interviews and saliva samples during the first 12 hours after delivery
Frequency of providers' positives attitudes and readiness to change
6 months before and after the implementation of the intervention

Study Arms (2)

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

Behavioral: Training in smoking cessation counseling

No implementation of the intervention

NO INTERVENTION

Standard in-service activities

Interventions

Training in smoking cessation counselingBEHAVIORAL

Implementation of intervention

Eligibility Criteria

Age12 Years - 49 Years

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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.

You may not qualify if:

None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Institute for Clinical Effectiveness and Health Policylead
Tulane Universitycollaborator
Centers for Disease Control and Preventioncollaborator

Study Sites (22)

Hospital Lucio Meléndez

Adrogué, Buenos Aires, Argentina

Location

Hospital Evita Pueblo

Berazategui, Buenos Aires, Argentina

Location

Hospital M.V de Martínez

General Pacheco, Buenos Aires, Argentina

Location

Hospital Narciso López

Lanús, Buenos Aires, Argentina

Location

Hospital Héroes de Malvinas

Merlo, Buenos Aires, Argentina

Location

Hospital Municipal Ostaciana B. de Lavignolle

Morón, Buenos Aires, Argentina

Location

Hospital Materno Infantil de San Isidro

San Isidro, Buenos Aires, Argentina

Location

Hospital Bocalandro

Tres de Febrero, Buenos Aires, Argentina

Location

Hospital Maternidad Santa Rosa

Vicente López, Buenos Aires, Argentina

Location

Hospital San Roque

Manuel B. Gonnet, La Plata, Argentina

Location

Centro de Salud Badano Repetto