跳至主要内容
临床试验/NCT03842449
NCT03842449Unknown不适用

Impact of Expired Carbon Monoxide Measurement on Smoking Cessation of Pregnant Women - Tobacco Pregnancy Addictive Pregnant Women

University Hospital, Limoges2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2019年3月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
102
试验地点
2
主要终点
Smoking cessation on the date of birth

研究概览

简要总结

France is the country of Europe where the prevalence of pregnant women smokers is the highest (35.9% before pregnancy and in the 3rd quarter 21.8% in 2008).

In the investigator's country, among the smokers of early pregnancy with the usual care, only 30% manage to stop during pregnancy.

Maternal smoking during pregnancy is a clearly identified risk factor for the course of pregnancy and the unborn child.

The measurement of carbon monoxide (CO) expired in pregnancy monitoring consultation is part of the recommendations of the consensus conference "Pregnancy and Tobacco" (ANAES, October 2004) and the parliamentary report on smoking by JL Touraine and D. Jacquat (Feb 2012). However, this recommendation has not entered the current practice. The research aims to justify the clinical relevance of this recommendation by demonstrating the positive impact of expired CO measurement on the rate of discontinuation during pregnancy.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Group of smoking pregnant women (N = 600):
  • Pregnant women declaring themselves smokers (at least one cigarette a day).
  • Aged at least 18 years old.
  • Consultant at Limoges University Hospital before the 24th week of amenorrhea.
  • Desiring to be followed for their entire pregnancy at the Children's.
  • Desiring to give birth at the Children's.
  • Accepting to participate in the study
  • Group of strictly non-smoking pregnant women (N = 50):
  • Pregnant women :
  • Declaring not to be a smoker (to have been totally weaned for more than one year and to have smoked less than 100 cigarettes in her lifetime) before the beginning of the current pregnancy, and
  • Whose partner and family do not smoke, and
  • Not significantly exposed to tobacco (in their professional environment in particular), and
  • With a CO measurement expired <3 ppm.
  • Aged at least 18 years old.
  • Consultant at Limoges University Hospital before the 24th SA.
  • Desiring to be followed for all their pregnancy and give birth at the Children's Hospital of Limoges.
  • Accepting to participate in the study.

排除标准

  • Group of smoking pregnant women (N = 600) :
  • Women with the following social and / or legal criteria: guardianship, curatorship, safeguard of justice.
  • Women unable to understand the objectives of the study and the constraints of the protocol.
  • Group of strictly non-smoking pregnant women (N = 50) :
  • Women with the following social and / or legal criteria: guardianship, curatorship, safeguard of justice.
  • Women unable to understand the objectives of the study and the constraints of the protocol.
  • Women with high blood pressure
  • Diabetic woman
  • Woman with hypothyroidism

结局指标

主要结局

Smoking cessation on the date of birth

时间窗: Date of birth

Evaluate the impact on maternal smoking cessation rate at birth of a strategy combining maternal expired CO measurement, restitution, and outcome comment initiated no later than at the 24th week of amenorrhea and conducted thoughout the whole pregnancy.

次要结局

  • Determinants of smoking cessation on the day of birth(Date of birth)
  • Impact on the intention of breastfeeding on the date of birth(Date of birth)
  • Predictive value of expired CO in relation to maternal-fetal exposure to these toxic and compounds(Date of birth)
  • Impact on maternal, placental and fetal exposure to the toxic and compounds of tobacco smoke.(Date of birth)
  • Maternal expired CO on the day of birth(Date of birth)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验