NCT01852617

A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,858 (actual)
• Sponsor: Institute for Clinical Effectiveness and Health Policy · Academic / Other
• Sex: Female
• Age: 12 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking Cessation
• Pregnancy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-11-01
• Completion: 2014-08-01
• First posted: 2013-05-14
• Last updated: 2015-01-30

Locations

22 sites across 2 countries: Argentina, Uruguay