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临床试验/NCT01852617
NCT01852617已完成不适用

A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay

Institute for Clinical Effectiveness and Health Policy22 个研究点 分布在 2 个国家目标入组 6,858 人开始时间: 2011年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6,858
试验地点
22
主要终点
Frequency of women receiving the cessation smoking advice

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
12 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • for prenatal clinics:

结局指标

主要结局

Frequency of women receiving the cessation smoking advice

时间窗: Interviews during the first 12 hours after delivery

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.

次要结局

  • Frequency of women who smoke at the end of pregnancy(Interviews and saliva samples during the first 12 hours after delivery)
  • Frequency of providers' positives attitudes and readiness to change(6 months before and after the implementation of the intervention)

研究者

发起方
Institute for Clinical Effectiveness and Health Policy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ezequiel Garcia Elorrio

Chief of Administration

Institute for Clinical Effectiveness and Health Policy

研究点 (22)

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