A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes and Its Correlation With Oral Flora (OHSOGDMAOF)

October 24, 2023 updated by: Rulin Liu, Fujian Medical University

A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes (GDM) and Its Correlation With Oral Flora

The aim of this observational study was to find out the oral status of pregnant women with GDM. The main questions it aims to answer are.

  • What is the oral status of pregnant women with GDM
  • Does GDM cause changes in the patient's oral flora Participants will describe the main tasks that participants will be asked to complete. The researcher will compare the [periodontal health group] to see if there is [different flora].

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. A self-administered general questionnaire, a semi-quantitative food frequency questionnaire, an oral health self-efficacy scale, an oral health literacy scale, and an oral health assessment scale were used for data collection to understand the current status of periodontitis in pregnant women with GDM, and to analyze the effects of demographic characteristics, dietary patterns, psychological factors and oral health-related knowledge on them; and biochemical indexes, such as fasting glucose, glycated hemoglobin, etc., and the outcome of pregnancy were collected in the late stage of pregnancy in pregnant women with GDM, so as to explore the effect of the current status of periodontitis in pregnant women with GDM on the outcome of their pregnancy.
  2. Forty cases of GDM pregnant women in the periodontal health group and 40 cases in the periodontitis group were randomly selected, and the saliva specimens of GDM pregnant women in the periodontal health group and GDM pregnant women in the periodontitis group were collected. Saliva specimens from GDM pregnant women in the healthy group and GDM pregnant women in the periodontitis group were collected in the late pregnancy period, and the oral flora was detected by 16S rRNA high-throughput sequencing technology, so as to compare the differences in the distribution of oral flora between the two groups and to analyze the correlation between oral flora and periodontitis among GDM pregnant women. flora of GDM pregnant women and its correlation with periodontitis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Rulin Liu, MSc student
  • Phone Number: 17728062728
  • Email: 601979085@qq.com

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

We included pregnant women with GDM at gestational weeks 27-36 who were willing to undergo oral examination and saliva collection and who had no serious pregnancy complications

Description

Inclusion Criteria:

  • age ≥ 18 years.
  • 27-36 weeks of pregnancy
  • receive a periodontal examination。
  • no serious periodontal disease before pregnancy
  • no communication problem
  • no serious pregnancy complications and comorbidities.

Exclusion Criteria:

  • history of oral antibiotics in the 3 months prior to the oral examination.
  • cognitively impaired, unable to complete the questionnaire.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Periodontal Health Group
GDM Pregnant Women with Periodontal Health Group
Other: Periodontitis Group
The exposed group was the group of pregnant women with GDM suffering from periodontitis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The self-administered general information questionnaire
Time Frame: 2023.4-2023.12
Explore the factors influencing periodontitis in pregnant women with GDM.
2023.4-2023.12
The semi-quantitative food frequency questionnaire
Time Frame: 2023.4-2023.12
Explore the factors influencing periodontitis in pregnant women with GDM.
2023.4-2023.12
The oral health self-efficacy scale
Time Frame: 2023.4-2023.12
Explore the factors influencing periodontitis in pregnant women with GDM.
2023.4-2023.12
The oral health literacy scale
Time Frame: 2023.4-2023.12
Explore the factors influencing periodontitis in pregnant women with GDM.
2023.4-2023.12
Characterization of the oral flora of pregnant women with GDM by 16sRNA high-throughput sequencing periodontitis
Time Frame: 2023.4-2023.12
We collected saliva specimens from GDM pregnant women in the periodontal health group and GDM pregnant women in the periodontitis group and examined their oral flora by 16S rRNA high-throughput sequencing, compared the differences in the distribution characteristics of the oral flora between the two groups, and analyzed the correlation between the oral flora of GDM pregnant women and their periodontitis.
2023.4-2023.12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The prevalence of periodontitis in pregnant women with GDM will be clarified by periodontal examination.
Time Frame: 2023.4-2023.12
The periodontal status of all subjects will be assessed by a dentist. Periodontitis will be diagnosed based on the diagnostic criteria of the Centers for Disease Control and Prevention of the American Academy of Periodontology (CDC/AAP).
2023.4-2023.12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaoqian Chen, Fujian Obstetrics and Gynecology Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022YJ080
  • Grant number: YCXH22-20 (Other Grant/Funding Number: Fujian Maternity and Child Health Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study isn't over yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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