Periodontal DiseasesC4MNCT03132207
The 4th Month Oral Consultation at Pregnant Women
An observational study of Periodontal Diseases and Pregnancy, run by Nantes University Hospital at 2 sites in France.
Trial summary
Epidemiological studies have suggested that maternal periodontitis affects the fetal-placental unit, with an increased risk of adverse pregnancy outcome. Indeed, it has been suggested that the direct or indirect action of parodontopathogenic bacteria induces an inflammatory cascade that leads to spontaneous premature… 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
- Periodontal Diseases, Pregnancy
- What is being tested?
- Non interventionel study
- How many people
- 622 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2017to 16 Mar 2018
- 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: This study will concern two populations: * pregnant women attending hospital during pregnancy monitoring and / or being hospitalized in one of the maternity wards associated with the project, * health professionals in charge of the follow-up of these pregnant women and their childbirth.
Who may be able to join
- Any woman who is consulting or hospitalized in a maternity unit participating in the project is eligible for the following criteria:
- a voluntary adult woman who gave oral consent
- pregnant women (2nd and 3rd trimesters) or postpartum women hospitalized at the maternity ward
- women agreeing to participate in the study
- For health professionals:
- midwife, maieutician, gynecologist and obstetrician,
- have graduated from a specialty,
- agreeing to participate in the study
Who cannot join
- child
- person under curatorship, under guardianship, deprived of liberty,
- refuse to fill in the questionnaire,
- no understanding of oral or written French,
- For health professionals:
- Not graduated
Trial locations and contacts
2 sites in 1 country.
France2 sites
Brest University Hospital
Brest, 29285
Nantes University Hospital
Nantes, 44093
About this study
Official title: The 4th Month Oral Consultation at Pregnant Women : Investigation Carried in Pregnant Women and Health Care Professionals of Nantes and Brest
Epidemiological studies have suggested that maternal periodontitis affects the fetal-placental unit, with an increased risk of adverse pregnancy outcome. Indeed, it has been suggested that the direct or indirect action of parodontopathogenic bacteria induces an inflammatory cascade that leads to spontaneous premature labor. Also, non-treatment of caries and periodontal disease can lead to acute pain and stress. This may promote self-medication and the inappropriate use of analgesic medications, potentially harmful to the health of the fetus. As part of the prevention of complications of pregnancy associated with oral diseases, the National Agency for Accreditation and Evaluation in Health (ANAES) has set up a system that allows any pregnant woman to consult between the 4th and 7th month of pregnancy, an oral health professional to carry out a complete assessment and free care. This study aims at evaluating this device among pregnant women and healthcare professionals 4 years after its implementation. On the other hand, it will make it possible to look for a possible link between the realization of an oral prenatal follow-up and the outcome of the pregnancy.
Read the detailed description
This study will concern two populations:
- pregnant women attending hospital during pregnancy monitoring and / or being hospitalized in one of the maternity wards associated with the project,
- health professionals in charge of the follow-up of these pregnant women and their childbirth.
The study will include:
- 500 pregnant women: 300 in Nantes and 200 in Brest
- 150 health professionals.
- Conditions
- Periodontal Diseases, Pregnancy
- Being tested
- Non interventionel study
- Keywords
- Oral Health, Pregnancy, Prevention, adverse pregnancy outcomes
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionel studyOther
Only one questionnaire will be done for women and professional
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women attending hospital during pregnancy monitoring and / or being hospitalized in one of the maternity wards associated with the project. Receives: Other: Non interventionel study | |
| Professional | health professionals in charge of the follow-up of these pregnant women and their childbirth. Receives: Other: Non interventionel study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the participation rate of pregnant women in the 4th month oral consultation in Nantes and Brest.
Participation (yes / no) in the oral consultation of the 4th month. This is the answer to question 10 of the patient questionnaire.
Measured: 4th month of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 Jun 2017
- Primary completion16 Mar 2018
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Nantes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132207
- Sponsor's protocol ID
- RC17_0138
- Acronym
- C4M
- Status last verified
- Apr 2019
- First submitted
- 24 Apr 2017
- Last updated
- 29 Apr 2019
- 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 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 4th Month Oral Consultation at Pregnant Women : Investigation Carried in Pregnant Women and Health Care Professionals of Nantes and Brest
- ClinicalTrials.gov ID
- NCT03132207
- Acronym / sponsor ID
- C4M / RC17_0138
- Conditions
- Periodontal Diseases, Pregnancy
- Keywords
- Oral Health, Pregnancy, Prevention, adverse pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Université de Nantes
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 16 Mar 2018 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 27 Apr 2017 (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.
Epidemiological studies have suggested that maternal periodontitis affects the fetal-placental unit, with an increased risk of adverse pregnancy outcome. Indeed, it has been suggested that the direct or indirect action of parodontopathogenic bacteria induces an inflammatory cascade that leads to spontaneous premature labor. Also, non-treatment of caries and periodontal disease can lead to acute pain and stress. This may promote self-medication and the inappropriate use of analgesic medications, potentially harmful to the health of the fetus. As part of the prevention of complications of pregnancy associated with oral diseases, the National Agency for Accreditation and Evaluation in Health (ANAES) has set up a system that allows any pregnant woman to consult between the 4th and 7th month of pregnancy, an oral health professional to carry out a complete assessment and free care. This study aims at evaluating this device among pregnant women and healthcare professionals 4 years after its implementation. On the other hand, it will make it possible to look for a possible link between the realization of an oral prenatal follow-up and the outcome of the pregnancy.
Detailed description
This study will concern two populations:
- pregnant women attending hospital during pregnancy monitoring and / or being hospitalized in one of the maternity wards associated with the project,
- health professionals in charge of the follow-up of these pregnant women and their childbirth.
The study will include:
- 500 pregnant women: 300 in Nantes and 200 in Brest
- 150 health professionals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: Non interventionel studyPregnant women attending hospital during pregnancy monitoring and / or being hospitalized in one of the maternity wards associated with the project. |
| Professional | – | Other: Non interventionel studyhealth professionals in charge of the follow-up of these pregnant women and their childbirth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will concern two populations: * pregnant women attending hospital during pregnancy monitoring and / or being hospitalized in one of the maternity wards associated with the project, * health professionals in charge of the follow-up of these pregnant women and their childbirth.
Key inclusion criteria (8 listed)
- Any woman who is consulting or hospitalized in a maternity unit participating in the project is eligible for the following criteria:
- a voluntary adult woman who gave oral consent
- pregnant women (2nd and 3rd trimesters) or postpartum women hospitalized at the maternity ward
- women agreeing to participate in the study
- midwife, maieutician, gynecologist and obstetrician,
Key exclusion criteria (6 listed)
- child
- person under curatorship, under guardianship, deprived of liberty,
- refuse to fill in the questionnaire,
- no understanding of oral or written French,
- Not graduated
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 |
|---|---|---|
| Non interventionel studyOnly one questionnaire will be done for women and professional | Other | Pregnant women, Professional |
Primary outcome
Evaluate the participation rate of pregnant women in the 4th month oral consultation in Nantes and Brest.
Time frame: 4th month of pregnancy
Participation (yes / no) in the oral consultation of the 4th month. This is the answer to question 10 of the patient questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Individual participant dataSharing planned: No
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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 Periodontal Diseases and Pregnancy, run by Nantes University Hospital 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 29 Apr 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the participation rate of pregnant women in the 4th month oral consultation in Nantes and Brest. (time frame: 4th month of pregnancy). 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 29 Apr 2019.