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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03499587
Other study ID # 206551
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 21, 2018
Est. completion date March 27, 2024

Study information

Verified date December 2023
Source Arkansas Children's Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this study is to see if there are negative effects of maternal obesity during pregnancy on offspring's brain development.


Description:

This study will recruit pregnant women who are either obese or normal weight and otherwise healthy. We will measure their body composition, food intake and other characteristics during pregnancy. When their babies are born, we will evaluate the brain development of their babies using magnetic resonance imaging and electroencephalography at age two weeks. We will then compare the findings and see if their are differences.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 13
Est. completion date March 27, 2024
Est. primary completion date March 27, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - BMI 18.5-25 or >30 with early OB visit medical records accessible - singleton pregnancy - about 36wks of pregnancy - at least 18 years of age Exclusion Criteria: - hypertension, diabetes, or other preexisting medical conditions - medications known to influence fetal growth - recreational drugs, nicotine or tobacco use of alcohol use while pregnant - pregnancy conception with assisted fertility treatment - medical complications developed during pregnancy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Arkansas Children's Nutrition Center Little Rock Arkansas

Sponsors (1)

Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine whether maternal obesity correlates with abnormal brain development in newborns Brain will be imaged at 2wks using an MRI 2 weeks
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