The 4th Month Oral Consultation at Pregnant Women

Pregnancy Clinical Trial

— C4M  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03132207
• Other study ID #: RC17_0138
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: March 16, 2018

Study information

• Verified date: April 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 622
• Est. completion date: March 16, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases
• Pregnancy

Intervention

Other:
• Non interventionel study
Only one questionnaire will be done for women and professional

Locations

Country	Name	City	State
France	Brest University Hospital	Brest
France	Nantes University Hospital	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Université de Nantes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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