The 4th Month Oral Consultation at Pregnant Women

Completed

• Conditions: Periodontal Diseases; Pregnancy
• Interventions: Other: Non interventionel study

• Registration Number: NCT03132207
• Lead Sponsor: Nantes University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-04-27
• Study Start: 2017-06-01
• Primary Completion: 2018-03-16
• Study Completion: 2018-03-16
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 622

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Professional	Non interventionel study	health professionals in charge of the follow-up of these pregnant women and their childbirth.
Pregnant women	Non interventionel study	Pregnant women attending hospital during pregnancy monitoring and / or being hospitalized in one of the maternity wards associated with the project.

Primary Outcome Measures

Name	Time	Method
Evaluate the participation rate of pregnant women in the 4th month oral consultation in Nantes and Brest.	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.

Trial Locations

Locations (2)

Brest University Hospital; 🇫🇷 Brest, France

Nantes University Hospital; 🇫🇷 Nantes, France