145/5000 Oral State and Knowledge, Attitudes and Practice... | NCT04269759

Studies
145/5000 Oral State and Knowledge, Attitudes and Practices of Pregnant Women on Their Oral Health and That of Their Unborn Child

NCT04269759

Sponsor

University Hospital, Bordeaux

Status

Completed

Last Update Posted

Mar 16, 2023Actual

Enrollment

117Actual

Phase

Not provided

Conditions

Dental Care

Interventions

Survey
dental care

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 13, 2019Actual

Primary Completion Date

Sep 9, 2019Actual

Completion Date

Sep 9, 2019Actual

First Submitted Date

Feb 7, 2020

First Submission Date that Met QC Criteria

Feb 11, 2020

First Posted Date

Feb 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2023

Last Update Posted Date

Mar 16, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pregnancy is a physiological condition which is accompanied by changes in the oral sphere which may increase the need for oral care and prevention. The role of dental surgeons is to provide appropriate care and to provide information on the prevention of oral diseases of pregnant women but also of their unborn baby.

Investigators wants to determine if pregnants women know that national health insurance has set up a free dental care preventive examination.

Detailed Description

Investigators will describe the knowledge, attitudes and practices of pregnant women consulting at the maternity of Bordeaux University Hospital with regard to the oral examination of health insurance.

This study will also Evaluate the care needs and the acceptability of oral screening and study the association between the use of prenatal health insurance and dental health.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

117Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnancy women			Other: Survey Other: dental care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Survey	Other	pregnant women will answer to a survey regarding their oral health knowledge, attitudes and practices for themselves and their unborn child	Pregnancy women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Use of prenatal health insurance for free dental examination	The use of this dental examination will be assessed with a survey	Enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women

Exclusion Criteria:

Patient refuses to participate in the study.
Persons under guardianship
No understanding of oral French.
People with decompensated severe psychiatric disorder or severe cognitive impairment.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Bordeaux		Bordeaux		33000	France

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires
D003729	Dental Care

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided