Clinical trial NCT02382601: Longitudinal Study of Intra-Uterine Growth Restriction
Official title: Longitudinal Study of Intra-Uterine Growth Restriction (IUGR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IUGR
Pregnancy
Keywords: Pregnancy
IUGR
Small for gestational age
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: The Perelman Family Foundation
First posted: 2015-03-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University of Colorado School of Medicine is a referral center for women carrying fetuses with IUGR. Care providers routinely evaluate more than 300 patients per year at our outreach sites alone whose fetuses have estimated fetal weights below the 10th percentile. Of these, the investigators will initially enroll 200 patients per year between 24 and 36 weeks over a two-year period.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Characterize the sequence of neurological and cardiovascular events defining early and late IUGR pathogenesis, respectively
timeFrame: Every two weeks from the time of IUGR diagnosis or first visit
Secondary outcomes:
measure: Correlate in utero adaptations in early and late IUGR, to infant and early childhood neurodevelopment
timeFrame: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
measure: Correlate in utero adaptations in early and late IUGR, to infant and early childhood cardiovascular outcomes
timeFrame: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
measure: Correlate in utero adaptations in early and late IUGR, to infant and early childhood metabolic outcomes
timeFrame: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
measure: Compare early IUGR, late IUGR and SGA infant and early childhood outcomes
timeFrame: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: John Hobbins, MD
role: PRINCIPAL_INVESTIGATOR
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