Pregnant Women's Tabacco Exposuretabac-GONCT06117943
Pregnant Women's Knowledge of the Active and Passive Smoking Effects on Pregnancy and the Fetus
An observational study of Pregnant Women's Tabacco Exposure, run by Université de Reims Champagne-Ardenne at 2 sites in France.
Trial summary
There are two remaining areas where the standards for tobacco use during pregnancy have changed little: one area is the high level of consumption by pregnant women and the other is the limited care given to pregnant women. 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
- Pregnant Women's Tabacco Exposure
- What is being tested?
- data collection
- How many people
- 500 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2023to 1 May 2024
- Phase
- Observational
- 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
Study population: Pregnant women exposed to passive or active smoking.
Who may be able to join
- pregnant women after 32 weeks of amenorrhea
- Primigravida women
- women exposed to passive or active smoking
- women aged over 18 years
- Accepting to participate in the study
Who cannot join
- Minors
- protected by law (guardianship, custodianship, judicial protection)
- refusing to participate in the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Ufr Medecine Urca
Reims, 51100
Université de Reims Champagne Ardenne
Reims, 51100
About this study
There are two remaining areas where the standards for tobacco use during pregnancy have changed little: one area is the high level of consumption by pregnant women and the other is the limited care given to pregnant women.
Indeed, many pregnant women are still over-exposed to tobacco, either through personal use or passive exposure to cigarette smoke. This passive exposure often comes from the consumption of their loved ones, such as their future co-parent or family.
Read more
However, throughout our lives, health professionals, associations, and the government send a lot of information and messages about the negative effects of tobacco on health, pregnancy, and the fetus.
This information and the possibility of receiving help from a professional trained in tobacco use exist throughout the entire pregnancy.
However, many women and their partners still do not take the necessary precautions to reduce or stop smoking. Do couples who smoke during pregnancy really have an understanding of the smoking's effects on women and their fetuses? Could they realize it and would they reduce or stop their consumption, in case they knew these negative effects?
Read the detailed description
The aims are:
- To describe the knowledge of pregnant women who smoke or are exposed to tobacco smoke about the effects of active and passive smoking on the obstetrical and fetal systems.
- To identify the information that has been received by pregnant women who smoke or are confronted with tobacco smoke about the effects of tobacco on pregnancy.
- To identify information sources for pregnant women who smoke or are exposed to tobacco smoke about the negative effects of tobacco on pregnancy.
- Conditions
- Pregnant Women's Tabacco Exposure
- Being tested
- data collection
- Keywords
- pregnancy, active smoking, passive smoking, fetus, knowledge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
Pregnant women who smoke personally or are passively exposed to cigarette smoke
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women who smoke personally or are passively exposed to cigarette smoke Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking effects on pregnancy questionnaire
Pregnant women's knowledge of the active and passive smoking effects on pregnancy : does the woman know or not risk of miscarriage, ectopic pregnancy, premature birth, premature rupture of membranes, low-lying placenta and retro-placental hematoma associated with smoking
Measured: day0
smoking effects on the fetus questionnaire
Pregnant women's knowledge of the active and passive smoking effects on the fetus : does the woman know or not risk of premature birth, growth delay, malformation, sudden infant death syndrome associated with smoking
Measured: day0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant Women's Tabacco ExposureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117943
- Sponsor's protocol ID
- 2023_RIPH_013_tabac-GO
- Acronym
- tabac-GO
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnant Women's Knowledge of the Active and Passive Smoking Effects on Pregnancy and the Fetus
- ClinicalTrials.gov ID
- NCT06117943
- Acronym / sponsor ID
- tabac-GO / 2023_RIPH_013_tabac-GO
- Conditions
- Pregnant Women's Tabacco Exposure
- Keywords
- pregnancy, active smoking, passive smoking, fetus, knowledge
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 7 Nov 2023 (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.
There are two remaining areas where the standards for tobacco use during pregnancy have changed little: one area is the high level of consumption by pregnant women and the other is the limited care given to pregnant women.
Indeed, many pregnant women are still over-exposed to tobacco, either through personal use or passive exposure to cigarette smoke. This passive exposure often comes from the consumption of their loved ones, such as their future co-parent or family.
However, throughout our lives, health professionals, associations, and the government send a lot of information and messages about the negative effects of tobacco on health, pregnancy, and the fetus.
This information and the possibility of receiving help from a professional trained in tobacco use exist throughout the entire pregnancy.
However, many women and their partners still do not take the necessary precautions to reduce or stop smoking. Do couples who smoke during pregnancy really have an understanding of the smoking's effects on women and their fetuses? Could they realize it and would they reduce or stop their consumption, in case they knew these negative effects?
Detailed description
The aims are:
- To describe the knowledge of pregnant women who smoke or are exposed to tobacco smoke about the effects of active and passive smoking on the obstetrical and fetal systems.
- To identify the information that has been received by pregnant women who smoke or are confronted with tobacco smoke about the effects of tobacco on pregnancy.
- To identify information sources for pregnant women who smoke or are exposed to tobacco smoke about the negative effects of tobacco on pregnancy.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: data collectionPregnant women who smoke personally or are passively exposed to cigarette smoke |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women exposed to passive or active smoking.
Key inclusion criteria (5 listed)
- pregnant women after 32 weeks of amenorrhea
- Primigravida women
- women exposed to passive or active smoking
- women aged over 18 years
- Accepting to participate in the study
Key exclusion criteria (3 listed)
- Minors
- protected by law (guardianship, custodianship, judicial protection)
- refusing to participate in the study
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 |
|---|---|---|
| data collectionPregnant women who smoke personally or are passively exposed to cigarette smoke | Other | Pregnant women |
Primary outcome
smoking effects on pregnancy questionnaire
Time frame: day0
Pregnant women's knowledge of the active and passive smoking effects on pregnancy : does the woman know or not risk of miscarriage, ectopic pregnancy, premature birth, premature rupture of membranes, low-lying placenta and retro-placental hematoma associated with smoking
smoking effects on the fetus questionnaire
Time frame: day0
Pregnant women's knowledge of the active and passive smoking effects on the fetus : does the woman know or not risk of premature birth, growth delay, malformation, sudden infant death syndrome associated with smoking
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Undecided
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women's Tabacco Exposure, run by Université de Reims Champagne-Ardenne at 2 sites 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 5 inclusion and 3 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 effects on pregnancy questionnaire (time frame: day0). The study lists 2 primary outcomes in all. 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 7 Nov 2023.