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The 4th Month Oral Consultation at Pregnant Women

The 4th Month Oral Consultation at Pregnant Women : Investigation Carried in Pregnant Women and Health Care Professionals of Nantes and Brest

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03132207
Acronym
C4M
Enrollment
622
Registered
2017-04-27
Start date
2017-06-01
Completion date
2018-03-16
Last updated
2019-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases, Pregnancy

Keywords

Oral Health, Pregnancy, Prevention, adverse pregnancy outcomes

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.

Interventions

OTHERNon interventionel study

Only one questionnaire will be done for women and professional

Sponsors

Université de Nantes
CollaboratorOTHER
Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the participation rate of pregnant women in the 4th month oral consultation in Nantes and Brest.4th month of pregnancyParticipation (yes / no) in the oral consultation of the 4th month. This is the answer to question 10 of the patient questionnaire.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026