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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

Tracking Information
First Submitted Date April 9, 2018
First Posted Date April 17, 2018
Last Update Posted Date April 14, 2020
Actual Study Start Date March 21, 2018
Estimated Primary Completion Date March 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 9, 2018)
Determine whether maternal obesity correlates with abnormal brain development in newborns [ Time Frame: 2 weeks ]
Brain will be imaged at 2wks using an MRI
Original Primary Outcome Measures Same as current
Change History
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 Effects of Maternal Obesity on Offspring Brain Development
Official Title Effects of Maternal Obesity on Offspring Brain Development
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples will be collected
Sampling Method Non-Probability Sample
Study Population Pregnant healthy volunteers
Condition Healthy
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 9, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 1, 2022
Estimated Primary Completion Date March 21, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03499587
Other Study ID Numbers 206551
Has Data Monitoring Committee Yes
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
Responsible Party Arkansas Children's Hospital Research Institute
Study Sponsor Arkansas Children's Hospital Research Institute
Collaborators Not Provided
Investigators Not Provided
PRS Account Arkansas Children's Hospital Research Institute
Verification Date April 2020