IUGR, Pregnancy
Conditions
Keywords
Pregnancy, IUGR, Small for gestational age
Brief summary
The investigation will employ a longitudinal approach in which every fetus diagnosed to be SGA (Small for Gestational Age ) will be studied at frequent intervals with sophisticated imaging techniques to assess subtle physiologic changes in the brain, heart, and placenta over time. These findings will be correlated with neurological and cardiovascular function in the newborn and early childhood. This research initiative should yield diagnostic and therapeutic templates that will improve the quality of life of IUGR babies in addition to providing important information that will better inform current diagnostic practices.
Detailed description
The overarching objective is to serially assess changes in the fetal circulation, heart, and brain with sophisticated ultrasound, MRI (Magnetic Resonance Imaging), and body composition techniques that will provide clues as to how growth restricted babies will tolerate life outside the uterus. Employing a longitudinal study will allow the investigators to correlate perinatal and postnatal outcomes more comprehensively than previous studies.
Interventions
RADIATIONUltrasound
With 3-D and 4-D high-resolution color Doppler methods it is possible to map out the placental circulation, fetal circulation, fetal brain, and fetal cardiac function. Investigators will collect these data points prenatally.
RADIATIONMRI
Similar to the Ultrasound data, investigators will collect MRI images of the fetal brain and the placenta. MRI will allow investigators to collect more detailed images of both the fetal brain and placenta, and investigators will be utilizing this technique both prenatally and postnatally.
PROCEDUREBlood collection
The maternal and cord blood will be collected for the processing of plasma and serum. There may be early biomarkers of IUGR in the maternal circulation that investigators can use to better determine the appropriate strategy for clinical management of care. Collection and subsequent analysis of molecular markers in the umbilical cord blood will be used to further confirm physiological dysfunction as detected by ultrasound and MRI techniques.
BEHAVIORALNeurological Function Assessment
Neurological development tests including a Bayley exam, Mullen exam, Developmental Profile-3, Child Behavior Checklist, and Pediatric Stroke Outcome Measure (PSOM) will be performed.
PROCEDUREPlacental Analysis
Placentas will undergo pathological evaluation for placental function.
PROCEDUREMeasurement of body fat
The baby's body fat will be measured in a special incubator called a PEAPOD or BODPOD when an infant.
RADIATIONPediatric heart ultrasound
Children will have ultrasounds of their hearts during follow-up visits.
Sponsors
University of Colorado, Denver
The Perelman Family Foundation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patients with diagnosed SGA by an ultrasound estimated fetal weight (EFW) of less than the 10th percentile or a fetal abdominal circumference of less than the 5th percentile will be included in the study at the time of their first examination.
Exclusion criteria
* Patients \< 18 years of age, and chromosomal anomalies as identified by regular aneuploidy screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize the sequence of neurological and cardiovascular events defining early and late IUGR pathogenesis, respectively | Every two weeks from the time of IUGR diagnosis or first visit | Using ultrasound and MRI to identify changes in the fetal vasculature, and fetal brain as early and late IUGR progress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlate in utero adaptations in early and late IUGR, to infant and early childhood neurodevelopment | Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years | Assess neurodevelopment with a series of tests (PSOM, Bayleys III, Mullen's Scale of Early Learning, Developmental Profile-3, Child Behavior Checklist) and correlate neurological in utero findings to neurodevelopment outcomes after birth. |
| Correlate in utero adaptations in early and late IUGR, to infant and early childhood cardiovascular outcomes | Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years | Assess cardiovascular health via heart ultrasound after birth |
| Correlate in utero adaptations in early and late IUGR, to infant and early childhood metabolic outcomes | Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years | Correlate IUGR severity to metabolic outcomes as assessed by body composition (pea pod and bod pod with a pediatric attachment), anthropometrics, and a diet questionnaire after birth. |
| Compare early IUGR, late IUGR and SGA infant and early childhood outcomes | Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years | Using the tests describe above compare the outcomes of each group after birth. |
Countries
United States
Contacts
CONTACTEmma Peek, BS
PRINCIPAL_INVESTIGATORJohn Hobbins, MD
University of Colorado, Denver
Outcome results
None listed