A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

Institute for Clinical Effectiveness and Health Policy

Status: Completed

Conditions: Smoking Cessation; Pregnancy

Treatments: Behavioral: Training in smoking cessation counseling

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01852617

1U48DP001948-01

Details and patient eligibility

About

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.

Enrollment: 6,858 patients

Sex: Female

Ages: 12 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,858 participants in 2 patient groups

Implementation of intervention

Experimental group

Description:

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

Treatment:

Behavioral: Training in smoking cessation counseling

No implementation of the intervention

No Intervention group

Description:

Standard in-service activities