Gestational Diabetes Mother-infant Cohort

NCT ID: NCT06021691

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Gestational Diabetes Mellitus in Pregnancy Cognitive Impairment Cohort Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Acquired nurturing environment

Intervention Type BEHAVIORAL

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

Acquired nurturing environment

Intervention Type BEHAVIORAL

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

Interventions

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Acquired nurturing environment

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gansu Provincial Maternal and Child Health Care Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheng Wang

Role: PRINCIPAL_INVESTIGATOR

Gansu Provincial Maternal and Child Health Care Hospital

Locations

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GansuPMCH

Lanzhou, Gansu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanxia Wang, Dr.

Role: CONTACT

86-0931-5188689

Facility Contacts

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Yanxia Wang, Dr.

Role: primary

13893210796

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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NCRCCHD-2022-GP-17

Identifier Type: -

Identifier Source: org_study_id

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