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Gestational Diabetes Mother-infant Cohort

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ClinicalTrials.gov Identifier: NCT06021691
Recruitment Status : Recruiting
First Posted : September 1, 2023
Last Update Posted : September 1, 2023
Sponsor:
Information provided by (Responsible Party):
Gansu Provincial Maternal and Child Health Care Hospital

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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
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Study Type : Observational
Estimated 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 : February 1, 2023
Estimated Primary Completion Date : November 30, 2025
Estimated Study Completion Date : November 30, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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."


Biospecimen Retention:   Samples With DNA
Collection of maternal peripheral blood during pregnancy and umbilical cord blood at delivery

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The pregnant women with abnormal blood glucose levels and the offspring
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06021691


Contacts
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Contact: Yanxia Wang, Dr. 86-0931-5188689 1091771450@qq.com

Locations
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China, Gansu
GansuPMCH Recruiting
Lanzhou, Gansu, China, 730050
Contact: Yanxia Wang, Dr.    13893210796    1091771450@qq.com   
Sponsors and Collaborators
Gansu Provincial Maternal and Child Health Care Hospital
Investigators
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Principal Investigator: Cheng Wang Gansu Provincial Maternal and Child Health Care Hospital
  Study Documents (Full-Text)

Documents provided by Gansu Provincial Maternal and Child Health Care Hospital:
Study Protocol  [PDF] April 20, 2023

More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Gansu Provincial Maternal and Child Health Care Hospital
ClinicalTrials.gov Identifier: NCT06021691    
Other Study ID Numbers: NCRCCHD-2022-GP-17
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: September 1, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gansu Provincial Maternal and Child Health Care Hospital:
Child cognitive impairment
Intrauterine high-glucose environment
Acquired nurture environment
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy in Diabetics
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Pregnancy Complications
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases