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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
6,858
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
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 Narciso López
Lanus, Buenos Aires, Argentina
Hospital Héroes de Malvinas
Merlo, Buenos Aires, Argentina
Hospital Municipal Ostaciana B. de Lavignolle
Morón, Buenos Aires, Argentina
Hospital Materno Infantil de San Isidro
San Isidro, Buenos Aires, Argentina
Hospital Bocalandro
Tres de Febrero, Buenos Aires, Argentina
Hospital Maternidad Santa Rosa
Vicente López, Buenos Aires, Argentina
Hospital San Roque
Manuel B. Gonnet, La Plata, Argentina
...and 12 more locations
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.
Time frame: Interviews during the first 12 hours after delivery
Frequency of women who smoke at the end of pregnancy
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.
Time frame: Interviews and saliva samples during the first 12 hours after delivery
Frequency of providers' positives attitudes and readiness to change
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.
Time frame: 6 months before and after the implementation of the intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.