Smoking CessationT-CAFENCT03842449
Impact of Expired Carbon Monoxide Measurement on Smoking Cessation of Pregnant Women
A study testing BabyCO and Biological samples in people with Smoking Cessation, run by University Hospital, Limoges at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- BabyCO and Biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2019to 18 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 17Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Women with high blood pressure
- Diabetic woman
- Woman with hypothyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- BabyCO, Biological samples
- Keywords
- Tobacco, Pregnancy Addictive, Pregnant Women, Stop smoking
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BabyCODiagnostic 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 samplesOther
The nature of the samples taken during the delivery are:
- maternal blood,
- cord blood
- placenta fragment
| Study group | Role | What they receive |
|---|---|---|
| Smoking pregnant woman withCO measurement | Experimental | Not described Receives: Diagnostic Test: BabyCO; Other: Biological samples |
| Smoking pregnant woman without CO measurement | Other | Not described Receives: Other: Biological samples |
| Non Smoking pregnant woman | Other | Not described Receives: Other: Biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Date of birth
Secondary outcomes (5)
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
Measured: Date of birth
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
Measured: Date of birth
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
Measured: Date of birth
Maternal expired CO on the day of birth
Maternal expired CO on the day of birth
Measured: Date of birth
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.
Measured: Date of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start18 Mar 2019
- Primary completion18 Mar 2022 (estimated)
- Study completion18 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842449
- Sponsor's protocol ID
- 87RC17_0069 (T-CAFE)
- Acronym
- T-CAFE
- Status last verified
- Mar 2021
- First submitted
- 25 Jan 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Expired Carbon Monoxide Measurement on Smoking Cessation of Pregnant Women - Tobacco Pregnancy Addictive Pregnant Women
- ClinicalTrials.gov ID
- NCT03842449
- Acronym / sponsor ID
- T-CAFE / 87RC17_0069 (T-CAFE)
- Conditions
- Smoking Cessation
- Keywords
- Tobacco, Pregnancy Addictive, Pregnant Women, Stop smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 18 Mar 2022 (estimated)
- Study completion
- 18 Mar 2022 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (9 listed)
- 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 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BabyCOAn expired CO measurement will be performed by BabyCO and the result will be returned to the smoking pregnant woman by the consultant. | Diagnostic test | Smoking pregnant woman withCO measurement |
| Biological samplesThe nature of the samples taken during the delivery are: * maternal blood, * cord blood * placenta fragment | Other | Non Smoking pregnant woman, Smoking pregnant woman withCO measurement, Smoking pregnant woman without CO measurement |
Primary outcome
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.
5 secondary outcomes
Impact on maternal, placental and fetal exposure to the toxic and compounds of tobacco smoke.
Time frame: Date of birth
Impact on the intention of breastfeeding on the date of birth
Time frame: Date of birth
Predictive value of expired CO in relation to maternal-fetal exposure to these toxic and compounds
Time frame: Date of birth
Maternal expired CO on the day of birth
Time frame: Date of birth
Determinants of smoking cessation on the day of birth
Time frame: Date of birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BabyCO and Biological samples in people with Smoking Cessation, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation on the date of birth (time frame: Date of birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.