Gestational Diabetes Mother-infant Cohort

Recruiting

• Conditions: Gestational Diabetes Mellitus in Pregnancy; Cohort Study; Cognitive Impairment
• Interventions: Behavioral: Acquired nurturing environment

• Registration Number: NCT06021691
• Lead Sponsor: Gansu Provincial Maternal and Child Health Care Hospital

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.

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 Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-06-07
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-28
• Last Update Submitted: 2023-08-28
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gestational diabetes offspring cohort	Acquired nurturing environment	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
Healthy maternal offspring cohort	Acquired nurturing environment	Healthy maternal offspring cohort is to learn about language development assessment in 2-year-old children and causal association with their health mother

Primary Outcome Measures

Name	Time	Method
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."

Trial Locations

Locations (1)

GansuPMCH; 🇨🇳 Lanzhou, Gansu, China