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

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: Recruiting
• Conditions: Periodontitis; Gestational Diabetes Mellitus; Oral Health
• Intervention / Treatment: Other: Periodontitis Group

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: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Rulin Liu, MSc student; Phone Number: 17728062728; Email: 601979085@qq.com
• Study Contact Backup: Name: Xiaoqian Chen; Phone Number: 18850768921; Email: 1334733063@qq.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Medical University
      • Contact: Ru-Lin Liu; Phone Number: 15880436099; Email: 601979085@qq.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
The self-administered general information questionnaire	Explore the factors influencing periodontitis in pregnant women with GDM.	2023.4-2023.12
The semi-quantitative food frequency questionnaire	Explore the factors influencing periodontitis in pregnant women with GDM.	2023.4-2023.12
The oral health self-efficacy scale	Explore the factors influencing periodontitis in pregnant women with GDM.	2023.4-2023.12
The oral health literacy scale	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	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

Outcome Measure	Measure Description	Time Frame
The prevalence of periodontitis in pregnant women with GDM will be clarified by periodontal examination.	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

• Sponsor: Fujian Medical University
• Investigators: Principal Investigator: Xiaoqian Chen, Fujian Obstetrics and Gynecology Hospital

Publications and helpful links

General Publications

• Li X, Zheng J, Ma X, Zhang B, Zhang J, Wang W, Sun C, Wang Y, Zheng J, Chen H, Tao J, Wang H, Zhang F, Wang J, Zhang H. The oral microbiome of pregnant women facilitates gestational diabetes discrimination. J Genet Genomics. 2021 Jan 20;48(1):32-39. doi: 10.1016/j.jgg.2020.11.006. Epub 2021 Jan 20.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): February 15, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Oral Health; Gestational diabetes mellitus; oral microorganisms
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Periodontitis; Diabetes, Gestational
• Other Study ID 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