Longitudinal Study of Intra-Uterine Growth Restriction

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT02382601
Status
Recruiting
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Conditions

  • IUGR
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound — RADIATION
    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.
  • MRI — RADIATION
    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.
  • Blood collection — PROCEDURE
    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.
  • Neurological Function Assessment — BEHAVIORAL
    Neurological development tests including a Bayley exam, Mullen exam, Developmental Profile-3, Child Behavior Checklist, and Pediatric Stroke Outcome Measure (PSOM) will be performed.
  • Placental Analysis — PROCEDURE
    Placentas will undergo pathological evaluation for placental function.
  • Measurement of body fat — PROCEDURE
    The baby's body fat will be measured in a special incubator called a PEAPOD or BODPOD when an infant.
  • Pediatric heart ultrasound — RADIATION
    Children will have ultrasounds of their hearts during follow-up visits.

Study Details

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.

Key Dates

Start date
Apr 30, 2015
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Small for Gestational Age Pregancies (controls)
    Small for gestational age (SGA) pregnancies that do not develop IUGR will be considered controls. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).
  • Arm: IUGR Pregnancies (cases)
    Small for gestational age (SGA) pregnancies that do develop IUGR will be considered cases. Each subject will have an ultrasound, MRI, maternal blood and cord blood collection, placental analysis, neurological function assessments (infant), and body fat measurements (infant).

Primary Outcome Measure

Characterize the sequence of neurological and cardiovascular events defining early and late IUGR pathogenesis, respectively [ Time Frame: Every two weeks from the time of IUGR diagnosis or first visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Denver Anschutz Medical CampusAuroraColorado80045
Emma Peek, BS
[email protected]
John Hobbins, MD (PRINCIPAL_INVESTIGATOR)
Henry Galan, MD (SUB_INVESTIGATOR)
Mike Zaretsky, MD (SUB_INVESTIGATOR)
Shane Reeves, MD (SUB_INVESTIGATOR)
Bettina Cuneo, MD (SUB_INVESTIGATOR)
Lisa Howley, MD (SUB_INVESTIGATOR)
David Mirsky, MD (SUB_INVESTIGATOR)
Mariana Meyers, MD (SUB_INVESTIGATOR)
Jennifer Armstrong-Wells, MD (SUB_INVESTIGATOR)
Laura Brown, MD (SUB_INVESTIGATOR)
Miriam Post, MD (SUB_INVESTIGATOR)
Sean Deoni, MD (SUB_INVESTIGATOR)
Sharon Hunter, PhD (SUB_INVESTIGATOR)
Naila Naushad, MBBS (SUB_INVESTIGATOR)
Jilliam Ellerman (SUB_INVESTIGATOR)
Diane Gumina, PhD (SUB_INVESTIGATOR)
Thomas Jansson, MD PhD (SUB_INVESTIGATOR)
Theresa Powell, PhD (SUB_INVESTIGATOR)
Colleen Julian, PhD (SUB_INVESTIGATOR)
Lorna Moore, PhD (SUB_INVESTIGATOR)
Emily Su, MD MSCI (SUB_INVESTIGATOR)
Emma Peek, BS (SUB_INVESTIGATOR)

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