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

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ClinicalTrials.gov Identifier: NCT03132207
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : August 11, 2017
Sponsor:
Collaborator:
Université de Nantes
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Periodontal Diseases Pregnancy 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
Estimated Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The 4th Month Oral Consultation at Pregnant Women : Investigation Carried in Pregnant Women and Health Care Professionals of Nantes and Brest
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : October 1, 2017
Estimated Study Completion Date : October 1, 2017

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132207


Contacts
Contact: Zahi BADRAN, Dr 02 40 41 29 27 zahi.bardan@chu-nantes.fr
Contact: Marjorie CHERAUD 02 40 08 73 83

Locations
France
Brest University Hospital Recruiting
Brest, France, 29285
Contact: Hervé BOUTIGNY, Pr         
Principal Investigator: Hervé BOUTIGNY, Pr         
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Zahi BADRAN, Dr    02 40 41 29 27    zahi.badran@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Université de Nantes

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03132207     History of Changes
Other Study ID Numbers: RC17_0138
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
Oral Health
Pregnancy
Prevention
adverse pregnancy outcomes

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases