A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

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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Key information

Conditions

Smoking Cessation Behavior Health Behavior Pregnancy

Age range

12 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Lucio Meléndez, Adrogué, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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.

Secondary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Institute for Clinical Effectiveness and Health Policy

Other

Collaborators

Centers for Disease Control and Prevention
Tulane University

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2014
First posted: May 14, 2013
Registry last updated: Jan 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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