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

April 26, 2019 updated by: Nantes University Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.
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.
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.
Time Frame: 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.
4th month of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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