Clinical trial NCT03132207: The 4th Month Oral Consultation at Pregnant Women
Official title: The 4th Month Oral Consultation at Pregnant Women : Investigation Carried in Pregnant Women and Health Care Professionals of Nantes and Brest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Pregnancy
Keywords: Oral Health
Pregnancy
Prevention
adverse pregnancy outcomes
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Université de Nantes
First posted: 2017-04-27
Enrollment: 622
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the participation rate of pregnant women in the 4th month oral consultation in Nantes and Brest.
timeFrame: 4th month of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References: