- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03132207
The 4th Month Oral Consultation at Pregnant Women (C4M)
April 26, 2019 updated by: Nantes University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
622
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brest, France, 29285
- Brest University Hospital
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Nantes, France, 44093
- Nantes University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria for pregnant women:
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
Exclusion Criteria for pregnant women:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pregnant women
Pregnant women attending hospital during pregnancy monitoring and / or being hospitalized in one of the maternity wards associated with the project.
|
Only one questionnaire will be done for women and professional
|
Professional
health professionals in charge of the follow-up of these pregnant women and their childbirth.
|
Only one questionnaire will be done for women and professional
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4th month of pregnancy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2017
Primary Completion (Actual)
March 16, 2018
Study Completion (Actual)
March 16, 2018
Study Registration Dates
First Submitted
April 24, 2017
First Submitted That Met QC Criteria
April 26, 2017
First Posted (Actual)
April 27, 2017
Study Record Updates
Last Update Posted (Actual)
April 29, 2019
Last Update Submitted That Met QC Criteria
April 26, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC17_0138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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