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
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Condition or disease | Intervention/treatment |
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Gestational Diabetes Mellitus in Pregnancy Cognitive Impairment Cohort Study | Behavioral: Acquired nurturing environment |
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 |
Group/Cohort | Intervention/treatment |
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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
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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
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Behavioral: Acquired nurturing environment
Superimposed effects of intrauterine high-sugar environment exposure and postnatal nurturing environment exposure |
- 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
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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 |
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.
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
Contact: Yanxia Wang, Dr. | 86-0931-5188689 | 1091771450@qq.com |
China, Gansu | |
GansuPMCH | Recruiting |
Lanzhou, Gansu, China, 730050 | |
Contact: Yanxia Wang, Dr. 13893210796 1091771450@qq.com |
Principal Investigator: | Cheng Wang | Gansu Provincial Maternal and Child Health Care Hospital |
Documents provided by Gansu Provincial Maternal and Child Health Care Hospital:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Child cognitive impairment Intrauterine high-glucose environment Acquired nurture environment |
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 |