The 4th Month Oral Consultation at Pregnant Women (C4M)

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Pregnancy
• Intervention / Treatment: Other: Non interventionel study

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.

• Study Type: Observational
• Enrollment (Actual): 622

Contacts and Locations

Study Locations

• France
  • Brest, France, 29285
    • Brest University Hospital
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Other: Non interventionel study; Only one questionnaire will be done for women and professional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Université de Nantes

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): March 16, 2018
• Study Completion (Actual): March 16, 2018

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Pregnancy; Prevention; Oral Health; adverse pregnancy outcomes
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: RC17_0138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No