Active — Not RecruitingNot Applicable

Maternal Obesity and Offspring Neurodevelopment

United States260 participantsStarted 2019-10-03

Plain-language 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 effects. Our overall hypothesis is that maternal obesity during pregnancy exposes the fetus to an inflammatory environment that affects infant brain structural and functional development and consequently neurodevelopmental outcomes. To test this hypothesis, the investigators will recruit normal-weight and obese pregnant women, examine inflammatory markers associated with obese pregnancy, and correlate them with offspring's brain development evaluated using quantitative MRI methods and outcomes evaluated using neurodevelopmental tests.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Singleton pregnancy * 11-13 weeks of gestation -≥18 years of age. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To detect changes in brain development by magnetic resonance imaging (MRI)

Timeframe: MRIs will be performed on babies at 2 weeks, 1 year, and 2 years.

Trial details

NCT IDNCT04274140

SponsorArkansas Children's Hospital Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-08-30

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