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

Not Applicable

• Conditions: Smoking Cessation
• Interventions: Diagnostic Test: BabyCO; Other: Biological samples

• Registration Number: NCT03842449
• Lead Sponsor: University Hospital, Limoges

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Study Start: 2019-03-18
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17
• Primary Completion: 2022-03-18
• Study Completion: 2022-03-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smoking pregnant woman withCO measurement	Biological samples	-
Smoking pregnant woman without CO measurement	Biological samples	-
Non Smoking pregnant woman	Biological samples	-
Smoking pregnant woman withCO measurement	BabyCO	-

Primary Outcome Measures

Name	Time	Method
Smoking cessation on the date of birth	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

Name	Time	Method
Determinants of smoking cessation on the day of birth	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.
Impact on the intention of breastfeeding on the date of birth	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	Date of birth	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	Date of birth	Maternal expired CO on the day of birth
Impact on maternal, placental and fetal exposure to the toxic and compounds of tobacco smoke.	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

Trial Locations

Locations (1)

University Hospital, Limoges; 🇫🇷 Limoges, France