The 4th Month Oral Consultation at Pregnant Women

NCT03132207 | Completed

• 1 other identifier: RC17_0138
• Study Type: observational
• Target: 622
• Locations: 1 country
• Sites: 2

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.

Conditions

Periodontal Diseases; Pregnancy

Keywords

Oral Health; Pregnancy; Prevention; adverse pregnancy outcomes

Outcome Measures

Primary Outcomes (1)

• 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.

  4th month of pregnancy

Study Arms (2)

Pregnant women

Pregnant women attending hospital during pregnancy monitoring and / or being hospitalized in one of the maternity wards associated with the project.

Other: Non interventionel study

Professional

health professionals in charge of the follow-up of these pregnant women and their childbirth.

Other: Non interventionel study

Interventions

Non interventionel study OTHER

Only one questionnaire will be done for women and professional

Pregnant women; Professional

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Université de Nantes: collaborator

Study Sites (2)

Brest University Hospital

Brest, 29285, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: June 1, 2017
• Primary Completion: March 16, 2018
• Study Completion: March 16, 2018
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)