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

NCT ID: NCT03842449

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2022-03-18

Brief Summary

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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

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Smoking pregnant woman withCO measurement

Group Type EXPERIMENTAL

BabyCO

Intervention Type 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.

Biological samples

Intervention Type OTHER

The nature of the samples taken during the delivery are:

* maternal blood,
* cord blood
* placenta fragment

Smoking pregnant woman without CO measurement

Group Type OTHER

Biological samples

Intervention Type OTHER

The nature of the samples taken during the delivery are:

* maternal blood,
* cord blood
* placenta fragment

Non Smoking pregnant woman

Group Type OTHER

Biological samples

Intervention Type OTHER

The nature of the samples taken during the delivery are:

* maternal blood,
* cord blood
* placenta fragment

Interventions

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BabyCO

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 DIAGNOSTIC_TEST

Biological samples

The nature of the samples taken during the delivery are:

* maternal blood,
* cord blood
* placenta fragment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital, Limoges

Limoges, , France

Site Status

Countries

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France

Other Identifiers

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87RC17_0069 (T-CAFE)

Identifier Type: -

Identifier Source: org_study_id

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