Impact of gestational diabetes on children's health
Effects of Gestational Giabetes Mellitus on Neuropsychological Development and Physique Growth in Children:a Cohort Study
This study looks at how gestational diabetes in mothers affects the health and development of their children during the first two years of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 510 (estimated) |
| Ages | 1 Month to 72 Months |
| Sex | All |
| Sponsor | Children's Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing) |
| Trial ID | NCT03997396 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of gestational diabetes mellitus (GDM) on the health and development of children, particularly focusing on their neuropsychological and physical growth. It aims to understand how maternal GDM influences children's health during critical early life stages, specifically the first 1000 days from conception to two years of age. The study will follow term infants born to mothers with GDM and assess various health outcomes, addressing a significant gap in existing research, especially in the Chinese population.
Who should consider this trial
Good fit: Ideal candidates for this study are term infants born to mothers diagnosed with gestational diabetes who meet specific health criteria.
Not a fit: Patients who may not benefit from this study include those whose mothers had pre-existing diabetes or other severe pregnancy complications.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved health outcomes for children born to mothers with gestational diabetes.
How similar studies have performed: While there have been international studies on the effects of GDM, this study is novel in its focus on the Chinese population and the long-term follow-up of children.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. term infant; 2. Apgar score\>=7 at birth； 3. single birth; 4. no obvious birth defects; 5. no other perinatal diseases that seriously affecting growth and development; 6. no congenital or genetic metabolic diseases that affect intelligence development; Exclusion Criteria: 1. mother with type 1 or type 2 diabetes before pregnancy; 2. the mother had no OGTT diagnosis results and was not diagnosed in strict accordance with the diagnostic criteria of GDM; 3. the mother had suffered from severe acute and chronic infectious diseases; 4. the mother has other pregnancy complications during pregnancy (hypertensionkidney disease,cardiovascular disease,liver disease,thyroid-related disease,cholestasis,severe anemia,etc.); 5. Mother's age\>35 years old; 6. the infants developed diseases that severely affected metabolism or normal growth and development during the follow-up.
Where this trial is running
Chongqing, Chongqing
- Growth, Development and Mental health of Children and Adolescence Center — Chongqing, Chongqing, China (Recruiting)
Study contacts
- Principal investigator: Chao Li, MB — Chongqing First People's Hospital of Liangjiang New Area
- Study coordinator: Li Chen, MD
- Email: chenli2012@126.com
- Phone: (+86)136 7762 0103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.