Clinical trial NCT01852617: A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay
Official title: A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Pregnancy
Keywords: Smoking Cessation
Pregnancy
Implementation
Knowledge translation
Lead sponsor: Institute for Clinical Effectiveness and Health Policy
Sponsor class: OTHER
Collaborators: name: Tulane University
name: Centers for Disease Control and Prevention
First posted: 2013-05-14
Enrollment: 6858
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Frequency of women receiving the cessation smoking advice
timeFrame: Interviews during the first 12 hours after delivery
Secondary outcomes:
measure: Frequency of women who smoke at the end of pregnancy
timeFrame: Interviews and saliva samples during the first 12 hours after delivery
measure: Frequency of providers' positives attitudes and readiness to change
timeFrame: 6 months before and after the implementation of the intervention
Other outcomes:
Locations:
city: Tres de Febrero
country: Argentina
facility: Hospital Bocalandro
state: Buenos Aires Province
city: Adrogué
country: Argentina
facility: Hospital Lucio Meléndez
state: Buenos Aires
city: Berazategui
country: Argentina
facility: Hospital Evita Pueblo
state: Buenos Aires
city: General Pacheco
country: Argentina
facility: Hospital M.V de Martínez
state: Buenos Aires
city: Lanús
country: Argentina
facility: Hospital Narciso López
state: Buenos Aires
city: Merlo
country: Argentina
facility: Hospital Héroes de Malvinas
state: Buenos Aires
city: Morón
country: Argentina
facility: Hospital Municipal Ostaciana B. de Lavignolle
state: Buenos Aires
city: San Isidro
country: Argentina
facility: Hospital Materno Infantil de San Isidro
state: Buenos Aires
city: Vicente López
country: Argentina
facility: Hospital Maternidad Santa Rosa
state: Buenos Aires
city: Gonnet
country: Argentina
facility: Hospital San Roque
state: La Plata
city: Montevideo
country: Uruguay
facility: Centro de Salud Badano Repetto
city: Montevideo
country: Uruguay
facility: Centro de Salud Cerro
city: Montevideo
country: Uruguay
facility: Centro de Salud Misurraco
city: Montevideo
country: Uruguay
facility: Centro de Salud Saint Bois
city: Montevideo
country: Uruguay
facility: Centro Materno Infantil 1
city: Montevideo
country: Uruguay
facility: Centro Materno Infantil 2
city: Montevideo
country: Uruguay
facility: Centro Materno Infantil 3
city: Montevideo
country: Uruguay
facility: Centro Materno Infantil 4
city: Montevideo
country: Uruguay
facility: Centro Materno Infantil 5
city: Montevideo
country: Uruguay
facility: Centro Materno Infantil 6
city: Montevideo
country: Uruguay
facility: Hospital Canzani
city: Montevideo
country: Uruguay
facility: Hospital Pereira Rossell
Study officials:
affiliation: Institute for Clinical Effectiveness and Health Policy
name: Fernando Althabe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Althabe F, Aleman A, Mazzoni A, Berrueta M, Morello P, Colomar M, Ciganda A, Becu A, Gibbons L, Llambi L, Bittar Gonzalez MG, Tong VT, Farr SL, Smith RA, Dietz PM, Johnson C, Buekens P, Belizan JM. Tobacco cessation intervention for pregnant women in Argentina and Uruguay: study protocol. Reprod Health. 2013 Aug 26;10(1):44. doi: 10.1186/1742-4755-10-44.