Gestational Diabetes Mother-infant Cohort

Sponsor

Gansu Provincial Maternal and Child Health Care Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06021691

Collaborator

(none)

600

Enrollment

Location

33.9

Anticipated Duration (Months)

17.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes Mellitus in Pregnancy Cognitive Impairment Cohort Study	Behavioral: Acquired nurturing environment

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 Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2025

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

delayed language development in children [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."

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 3 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.