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

Smoking Cessation Clinical Trial

— T-CAFE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03842449
• Other study ID #: 87RC17_0069 (T-CAFE)
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: March 18, 2022

Study information

• Verified date: March 2021
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: March 18, 2022
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
France	University Hospital, Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Date of birth
Secondary	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	Date of birth
Secondary	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	Date of birth
Secondary	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	Date of birth
Secondary	Maternal expired CO on the day of birth	Maternal expired CO on the day of birth	Date of birth
Secondary	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.	Date of birth