Status:
ACTIVE_NOT_RECRUITING
Maternal Obesity and Offspring Neurodevelopment
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Brief Summary
Our goals are to characterize the effects of maternal obesity during pregnancy on infant brain development, reveal the neurodevelopmental consequences, and identify possible mechanisms causing these e...
Detailed Description
About one third of all women of reproductive age in the US are obese (body mass index \[BMI\] ≥ 30). Recent studies show that children born to mothers who were obese while pregnant may have lower cogn...
Eligibility Criteria
Inclusion
- Singleton pregnancy
- 11-13 weeks of gestation -≥18 years of age.
Exclusion
- BMI measured at first study visit \<18.5 or between 26-29 or \>50
- hypertension, diabetes, or other preexisting medical conditions known or suspect (by the research team) to influence fetal growth;
- family history of psychological or neurogenetic disorders as determined by the research team that may increase the risk of adverse neurodevelopmental outcomes in offspring
- medications known to influence fetal growth
- recreational drugs, nicotine or tobacco (including smokeless) use or alcohol use while pregnant
- medical conditions developed during pregnancy (e.g. gestational diabetes, preeclampsia) known or suspected by the research team to influence fetal growth
- infants born preterm (\<37 weeks of gestation), with congenital defects, intrauterine growth restriction, small for gestational age, macrosomia, hypoglycemia, low Apgar score (\<7), or any other medical complications at birth suspected affecting development
Key Trial Info
Start Date :
October 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04274140
Start Date
October 3 2019
End Date
October 31 2027
Last Update
December 15 2025
Active Locations (1)
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1
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202