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

March 16, 2021 updated by: University Hospital, Limoges

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • University Hospital, Limoges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smoking pregnant woman withCO measurement
Diagnostic test: BabyCO
An expired CO measurement will be performed by BabyCO and the result will be returned to the smoking pregnant woman by the consultant.
Other: Biological samples

The nature of the samples taken during the delivery are:

  • maternal blood,
  • cord blood
  • placenta fragment
Other: Smoking pregnant woman without CO measurement
Other: Biological samples

The nature of the samples taken during the delivery are:

  • maternal blood,
  • cord blood
  • placenta fragment
Other: Non Smoking pregnant woman
Other: Biological samples

The nature of the samples taken during the delivery are:

  • maternal blood,
  • cord blood
  • placenta fragment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking cessation on the date of birth
Time Frame: 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.
Date of birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact on maternal, placental and fetal exposure to the toxic and compounds of tobacco smoke.
Time Frame: Date of birth
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
Date of birth
Impact on the intention of breastfeeding on the date of birth
Time Frame: Date of birth
Impact on the intention of breastfeeding on the date of birth evaluated by a questionnaire
Date of birth
Predictive value of expired CO in relation to maternal-fetal exposure to these toxic and compounds
Time Frame: Date of birth
Determine the predictive value of expired CO in relation to maternal-fetal exposure to these toxic and compounds
Date of birth
Maternal expired CO on the day of birth
Time Frame: Date of birth
Maternal expired CO on the day of birth
Date of birth
Determinants of smoking cessation on the day of birth
Time Frame: Date 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.
Date of birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2019

Primary Completion (Anticipated)

March 18, 2022

Study Completion (Anticipated)

March 18, 2022

Study Registration Dates

First Submitted

January 25, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87RC17_0069 (T-CAFE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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