Phase 1
N=22
PED NEONAT 20-000599 Fetal Body Composition
IUGR · Gestational Diabetes · Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT04508751 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Maternal Visceral Adipose Tissue Volume — 97593; 169626; 96787 mm3
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 3T "Free-Breathing" Fetal Magnetic Resonance Imaging (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, Los Angeles
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Visceral Adipose Tissue Volume |
97593; 169626; 96787 | — |
| PRIMARY Fetal Liver PDFF |
3.2; 5.2; 1.9 | — |
| SECONDARY Fetal Subcutaneous Tissue Volume |
241; 280; 220 | — |
| SECONDARY Maternal Subcutaneous Tissue Volume |
157319; 216264; 159197 | — |
| SECONDARY Maternal Hepatic Fat PDFF |
2.1; 3.2; 2.2 | — |
Summary
Obesity is an ongoing public health problem that is difficult to treat. There is evidence that obesity has fetal origins. Body composition, including visceral, subcutaneous, brown, and hepatic fat have been found to be important predictors in obesity and metabolic syndrome. Magnetic resonance imaging (MRI) can quantify body composition that does not require radiation but is motion limited. The investigators have developed a motion-compensated MRI sequence, also known as "free breathing" MRI. In this study, the investigators plan to obtain free-breathing MRIs of pregnant women in the third trimester of pregnancy. MRIs will be obtained from healthy mothers, mothers with growth-restricted fetuses, and mothers with gestational diabetes. The different types of adipose tissue will be measured and compared between groups and correlated to birth growth parameters. The goal is this study is to assess if motion-compensated MRI can help predict early growth patterns in infancy.
Eligibility Criteria
Inclusion Criteria
- Pregnant women with singleton pregnancies (healthy cohort)
- Pregnant women with fetuses with weights < 10th percentile weight for gestational age (IUGR cohort)
- Pregnant women with gestational diabetes (diabetes cohort)
Exclusion Criteria
- Pregnant minors
- Major congenital anomalies or disease processes in the fetus
- Fetus with known chromosomal anomalies
- Mothers who do not plan to deliver at UCLA
- Multiple pregnancy (i.e. twins, triplets, etc)
- History of claustrophobia
- Contraindications to MRI such as metallic devices in the body that are not MRI compatible
Data sourced from ClinicalTrials.gov (NCT04508751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.