Gestational Diabetes Mother-infant Cohort

August 28, 2023 updated by: Gansu Provincial Maternal and Child Health Care Hospital

A Cohort Study on the Impact of Gestational Blood Glucose Management and Postnatal Nurturing Environment on Delayed Language Development in Children

The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children. The study investigated the results of blood glucose screening during pregnancy for the children's mothers, and followed up on the blood glucose management effectiveness of pregnant women with abnormal blood glucose levels before delivery. Participants will be also surveyed the "S-S method for language development assessment, "gsell Scale", and "0-6 year-old family nurturing environment evaluation scale" to evaluate the language development and family nurturing environment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Glucose management during pregnancy and the postnatal nurturing environment are keys to early detection and early intervention of language delay, which is important to reduce abnormal language development in children. In this study, mothers diagnosed with gestational diabetes mellitus in the department of hospital and offspring were used as participants. The investigators take a follow-up visit to participants' offspring using the S-S method of language development assessment, gsell Infant and Toddler Development Scale, and 0-6 years old family parenting environment evaluation scale. The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children.

Study Type

Observational

Enrollment (Estimated)

600

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 Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Recruiting
        • GansuPMCH
        • 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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The pregnant women with abnormal blood glucose levels and the offspring

Description

Inclusion Criteria:

  • Children 1.5-2.5 years old with no serious underlying diseases and no hearing impairment.

Exclusion Criteria:

  • diagnosed hearing impairment, organic dysarthria, oral disease; (ii) cerebral palsy;
  • neurological and hereditary metabolic diseases; (iv) deaf father/mother.

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
Intervention / Treatment
Gestational diabetes offspring cohort
The Gestational diabetes(GDM) offspring cohort is to learn about language development assessment in 2-year-old children and causal association with their mother who diagnosed GDM
Behavioral: Acquired nurturing environment
Superimposed effects of intrauterine high-sugar environment exposure and postnatal nurturing environment exposure
Healthy maternal offspring cohort
Healthy maternal offspring cohort is to learn about language development assessment in 2-year-old children and causal association with their health mother
Behavioral: Acquired nurturing environment
Superimposed effects of intrauterine high-sugar environment exposure and postnatal nurturing environment exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
delayed language development in children
Time Frame: 2023.1-2025.11
"Number of participants diagnosed with GDM," "Number of offspring of participants who participated in the survey of family nurturing environments," and "Composition ratio of offspring with GDM who presented with language delays."
2023.1-2025.11

Collaborators and Investigators

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

Sponsor

Gansu Provincial Maternal and Child Health Care Hospital

Investigators

  • Principal Investigator: Cheng Wang, Gansu Provincial Maternal and Child Health Care Hospital

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)

February 1, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

June 7, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRCCHD-2022-GP-17

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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