A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

Pregnancy Clinical Trial

Official title:

A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852617
• Other study ID #: 1U48DP001948-01
• Status: Completed
• Phase: N/A
• First received: June 22, 2011
• Last updated: January 29, 2015
• Start date: October 2011
• Est. completion date: August 2014

Study information

• Verified date: January 2015
• Source: Institute for Clinical Effectiveness and Health Policy
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Centers for Disease Control and PreventionArgentina: Institutional Review BoardArgentina: Institute for Clinical Effectiveness and Health PolicyUruguay: Comite de Etica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6858
• Est. completion date: August 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 49 Years

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pregnancy
• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
Argentina	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 San Roque	Gonnet	La Plata
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	Hospital Materno Infantil de San Isidro	San Isidro	Buenos Aires
Argentina	Hospital Bocalandro	Tres de Febrero	Buenos Aires Province
Argentina	Hospital Maternidad Santa Rosa	Vicente López	Buenos Aires
Uruguay	Centro de Salud Badano Repetto	Montevideo
Uruguay	Centro de Salud Cerro	Montevideo
Uruguay	Centro de Salud Misurraco	Montevideo
Uruguay	Centro de Salud Saint Bois	Montevideo
Uruguay	Centro Materno Infantil 1	Montevideo
Uruguay	Centro Materno Infantil 2	Montevideo
Uruguay	Centro Materno Infantil 3	Montevideo
Uruguay	Centro Materno Infantil 4	Montevideo
Uruguay	Centro Materno Infantil 5	Montevideo
Uruguay	Centro Materno Infantil 6	Montevideo
Uruguay	Hospital Canzani	Montevideo
Uruguay	Hospital Pereira Rossell	Montevideo

Sponsors (3)

Lead Sponsor	Collaborator
Institute for Clinical Effectiveness and Health Policy	Centers for Disease Control and Prevention, Tulane University

Countries where clinical trial is conducted

Argentina,  Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Interviews during the first 12 hours after delivery	No
Secondary	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.	Interviews and saliva samples during the first 12 hours after delivery	No
Secondary	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.	6 months before and after the implementation of the intervention	No