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Impact of Expired Carbon Monoxide Measurement on Smoking Cessation of Pregnant Women (T-CAFE)

Primary Purpose

Smoking Cessation

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BabyCO
Biological samples
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking Cessation focused on measuring Tobacco, Pregnancy Addictive, Pregnant Women, Stop smoking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria :

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.

Exclusion Criteria :

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

Sites / Locations

  • University Hospital, Limoges

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Other

Arm Label

Smoking pregnant woman withCO measurement

Smoking pregnant woman without CO measurement

Non Smoking pregnant woman

Arm Description

Outcomes

Primary Outcome Measures

Smoking cessation on the 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.

Secondary Outcome Measures

Impact on maternal, placental and fetal exposure to the toxic and compounds of tobacco smoke.
Impact on maternal, placental and fetal exposure to the toxic and compounds of tobacco smoke measured in maternal, cordal blood and placenta by ICP-MS, GC-MS and LC-MS methods
Impact on the intention of breastfeeding on the date of birth
Impact on the intention of breastfeeding on the date of birth evaluated by a questionnaire
Predictive value of expired CO in relation to maternal-fetal exposure to these toxic and compounds
Determine the predictive value of expired CO in relation to maternal-fetal exposure to these toxic and compounds
Maternal expired CO on the day of birth
Maternal expired CO on the day of birth
Determinants of smoking cessation on the day of birth
Potential determinants of smoking cessation, including: age, parity, precariousness assessed by the EPICES score, history of smoking before pregnancy, expired CO measurement, etc.

Full Information

First Posted
January 25, 2019
Last Updated
March 16, 2021
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT03842449
Brief Title
Impact of Expired Carbon Monoxide Measurement on Smoking Cessation of Pregnant Women
Acronym
T-CAFE
Official Title
Impact of Expired Carbon Monoxide Measurement on Smoking Cessation of Pregnant Women - Tobacco Pregnancy Addictive Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
March 18, 2022 (Anticipated)
Study Completion Date
March 18, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
Keywords
Tobacco, Pregnancy Addictive, Pregnant Women, Stop smoking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smoking pregnant woman withCO measurement
Arm Type
Experimental
Arm Title
Smoking pregnant woman without CO measurement
Arm Type
Other
Arm Title
Non Smoking pregnant woman
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
BabyCO
Intervention Description
An expired CO measurement will be performed by BabyCO and the result will be returned to the smoking pregnant woman by the consultant.
Intervention Type
Other
Intervention Name(s)
Biological samples
Intervention Description
The nature of the samples taken during the delivery are: maternal blood, cord blood placenta fragment
Primary Outcome Measure Information:
Title
Smoking cessation on the date of birth
Description
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.
Time Frame
Date of birth
Secondary Outcome Measure Information:
Title
Impact on maternal, placental and fetal exposure to the toxic and compounds of tobacco smoke.
Description
Impact on maternal, placental and fetal exposure to the toxic and compounds of tobacco smoke measured in maternal, cordal blood and placenta by ICP-MS, GC-MS and LC-MS methods
Time Frame
Date of birth
Title
Impact on the intention of breastfeeding on the date of birth
Description
Impact on the intention of breastfeeding on the date of birth evaluated by a questionnaire
Time Frame
Date of birth
Title
Predictive value of expired CO in relation to maternal-fetal exposure to these toxic and compounds
Description
Determine the predictive value of expired CO in relation to maternal-fetal exposure to these toxic and compounds
Time Frame
Date of birth
Title
Maternal expired CO on the day of birth
Description
Maternal expired CO on the day of birth
Time Frame
Date of birth
Title
Determinants of smoking cessation on the day of birth
Description
Potential determinants of smoking cessation, including: age, parity, precariousness assessed by the EPICES score, history of smoking before pregnancy, expired CO measurement, etc.
Time Frame
Date of birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria : 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. Exclusion Criteria : 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
Facility Information:
Facility Name
University Hospital, Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Expired Carbon Monoxide Measurement on Smoking Cessation of Pregnant Women

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