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Effects of Maternal Obesity on Offspring Brain Development

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499587
Recruitment Status : Active, not recruiting
First Posted : April 17, 2018
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

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

Condition or disease
Healthy

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Maternal Obesity on Offspring Brain Development
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : March 21, 2022
Estimated Study Completion Date : August 1, 2022

Group/Cohort
Obese pregnant women
BMI >30 with early OB visit medical records accessible
Normal weight pregnant women
BMI 18.5-25 with early OB visit medical records accessible.



Primary Outcome Measures :
  1. Determine whether maternal obesity correlates with abnormal brain development in newborns [ Time Frame: 2 weeks ]
    Brain will be imaged at 2wks using an MRI


Biospecimen Retention:   Samples Without DNA
Blood samples will be collected


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant healthy volunteers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499587


Locations
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United States, Arkansas
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03499587    
Other Study ID Numbers: 206551
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms