Gestational Diabetes Mother-infant Cohort

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

Tracking Information

• First Submitted Date: June 7, 2023
• First Posted Date: September 1, 2023
• Last Update Posted Date: September 1, 2023
• Actual Study Start Date: February 1, 2023
• Estimated Primary Completion Date: November 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 28, 2023)

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."

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Gestational Diabetes Mother-infant Cohort
• Official Title: A Cohort Study on the Impact of Gestational Blood Glucose Management and Postnatal Nurturing Environment on Delayed Language Development in Children
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

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

• Sampling Method: Probability Sample
• Study Population: The pregnant women with abnormal blood glucose levels and the offspring

Condition

• Gestational Diabetes Mellitus in Pregnancy
• Cognitive Impairment
• Cohort Study

Intervention

Behavioral: Acquired nurturing environment

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

Study Groups/Cohorts

• 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
  Intervention: 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
  Intervention: Behavioral: Acquired nurturing environment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 28, 2023): 600
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2025
• Estimated Primary Completion Date: November 30, 2025 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 3 Years (Child)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT06021691
• Other Study ID Numbers: NCRCCHD-2022-GP-17
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Gansu Provincial Maternal and Child Health Care Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Gansu Provincial Maternal and Child Health Care Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Cheng Wang; Gansu Provincial Maternal and Child Health Care Hospital

• PRS Account: Gansu Provincial Maternal and Child Health Care Hospital
• Verification Date: August 2023