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

NCT03842449 | Unknown

• 1 other identifier: 87RC17_0069 (T-CAFE)
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

Tobacco; Pregnancy Addictive; Pregnant Women; Stop smoking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Impact on maternal, placental and fetal exposure to the toxic and compounds of tobacco smoke.

  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

• Maternal expired CO on the day of birth

  Date of birth

• Determinants of smoking cessation on the day of birth

  Date of birth

Study Arms (3)

Smoking pregnant woman withCO measurement

EXPERIMENTAL

Diagnostic Test: BabyCO; Other: Biological samples

Smoking pregnant woman without CO measurement

OTHER

Other: Biological samples

Non Smoking pregnant woman

OTHER

Other: Biological samples

Interventions

BabyCO DIAGNOSTIC_TEST

An expired CO measurement will be performed by BabyCO and the result will be returned to the smoking pregnant woman by the consultant.

Smoking pregnant woman withCO measurement

Biological samples OTHER

The nature of the samples taken during the delivery are: * maternal blood, * cord blood * placenta fragment

Non Smoking pregnant woman; Smoking pregnant woman withCO measurement; Smoking pregnant woman without CO measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

University Hospital, Limoges

Limoges, 87042, France

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: February 15, 2019
• Study Start: March 18, 2019
• Primary Completion: March 18, 2022
• Study Completion: March 18, 2022
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)