Gestational Diabetes Mother-infant Cohort

NCT06021691 | Unknown

• 1 other identifier: NCRCCHD-2022-GP-17
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy; Cognitive Impairment; Cohort Study

Keywords

Child cognitive impairment; Intrauterine high-glucose environment; Acquired nurture environment

Outcome Measures

Primary Outcomes (1)

• delayed language development in children

  "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

Study Arms (2)

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

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

Interventions

Acquired nurturing environment BEHAVIORAL

Superimposed effects of intrauterine high-sugar environment exposure and postnatal nurturing environment exposure

Gestational diabetes offspring cohort; Healthy maternal offspring cohort

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The pregnant women with abnormal blood glucose levels and the offspring

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gansu Provincial Maternal and Child Health Care Hospital: lead

Study Sites (1)

GansuPMCH

Lanzhou, Gansu, 730050, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Collection of maternal peripheral blood during pregnancy and umbilical cord blood at delivery

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Cheng Wang

  Gansu Provincial Maternal and Child Health Care Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanxia Wang, Dr.

CONTACT

86-0931-5188689; 1091771450@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: September 1, 2023
• Study Start: February 1, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

CN (1)