C4M: The 4th Month Oral Consultation at Pregnant Women

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03132207

Collaborator

Université de Nantes (Other)

622

Enrollment

Locations

9.5

Actual Duration (Months)

311

Patients Per Site

32.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

622 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 :

Jun 1, 2017

Actual Primary Completion Date :

Mar 16, 2018

Actual Study Completion Date :

Mar 16, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brest University Hospital	Brest		France	29285
2	Nantes University Hospital	Nantes		France	44093

Sponsors and Collaborators

Nantes University Hospital
Université de Nantes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT03132207

Other Study ID Numbers:

RC17_0138

First Posted:

Apr 27, 2017

Last Update Posted:

Apr 29, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nantes University Hospital

Oral Health

Pregnancy

Prevention

adverse pregnancy outcomes

Additional relevant MeSH terms:

Periodontal Diseases

Study Results

No Results Posted as of Apr 29, 2019