A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

Not Applicable

Completed

• Conditions: Smoking Cessation; Pregnancy
• Interventions: Behavioral: Training in smoking cessation counseling

• Registration Number: NCT01852617
• Lead Sponsor: Institute for Clinical Effectiveness and Health Policy

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-22
• Study Start: 2011-10
• Study First Submitted QC: 2013-05-09
• Study First Posted: 2013-05-14
• Primary Completion: 2013-11
• Study Completion: 2014-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-29
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6858

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implementation of intervention	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

Primary Outcome Measures

Name	Time	Method
Frequency of women receiving the cessation smoking advice	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 Outcome Measures

Name	Time	Method
Frequency of women who smoke at the end of pregnancy	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	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.

Trial Locations

Locations (22)

Centro de Salud Badano Repetto; 🇺🇾 Montevideo, Uruguay

Centro de Salud Misurraco; 🇺🇾 Montevideo, Uruguay

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 Bocalandro; 🇦🇷 Tres de Febrero, Buenos Aires Province, 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

Centro de Salud Cerro; 🇺🇾 Montevideo, Uruguay

Hospital Materno Infantil de San Isidro; 🇦🇷 San Isidro, Buenos Aires, Argentina

Centro Materno Infantil 5; 🇺🇾 Montevideo, Uruguay

Centro Materno Infantil 6; 🇺🇾 Montevideo, Uruguay

Hospital San Roque; 🇦🇷 Gonnet, La Plata, Argentina

Centro Materno Infantil 1; 🇺🇾 Montevideo, Uruguay

Centro Materno Infantil 4; 🇺🇾 Montevideo, Uruguay

Hospital Canzani; 🇺🇾 Montevideo, Uruguay

Centro de Salud Saint Bois; 🇺🇾 Montevideo, Uruguay

Centro Materno Infantil 2; 🇺🇾 Montevideo, Uruguay

Centro Materno Infantil 3; 🇺🇾 Montevideo, Uruguay

Hospital Maternidad Santa Rosa; 🇦🇷 Vicente López, Buenos Aires, Argentina

Hospital Pereira Rossell; 🇺🇾 Montevideo, Uruguay