The 4th Month Oral Consultation at Pregnant Women

NCT ID: NCT03132207

Last Updated: 2019-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 622 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-03-16

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.

Conditions

Periodontal Diseases; Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant women

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

Non interventionel study

Intervention Type: OTHER

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.

Non interventionel study

Intervention Type: OTHER

Only one questionnaire will be done for women and professional

Interventions

Non interventionel study

Only one questionnaire will be done for women and professional

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Université de Nantes

OTHER

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brest University Hospital

Brest, , France

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

RC17_0138

Identifier Type: -

Identifier Source: org_study_id