Completed

NCT Number: NCT03132207

The 4th Month Oral Consultation at Pregnant Women

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Pregnancy Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Brest University Hospital, Brest, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non interventionel study

Other

Only one questionnaire will be done for women and professional

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

Université de Nantes

Registry information

Official study title

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

Acronym: C4M

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Apr 27, 2017
Registry last updated: Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed