Health TrialsbyHealthPanel

Longitudinal Study of Intra-Uterine Growth Restriction

ConditionsIUGRPregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients < 18 years of age, and chromosomal anomalies as identified by regular aneuploidy screening.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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/Surgery

    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/Surgery

    Placentas will undergo pathological evaluation for placental function.

  • Measurement of body fat

    Procedure/Surgery

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Small for Gestational Age Pregancies (controls)7 interventions
Group B: IUGR Pregnancies (cases)7 interventions

Trial outcomes

Primary outcomes

1

Characterize the sequence of neurological and cardiovascular events defining early and late IUGR pathogenesis, respectively

Using ultrasound and MRI to identify changes in the fetal vasculature, and fetal brain as early and late IUGR progress.

Time frame
Every two weeks from the time of IUGR diagnosis or first visit

Secondary outcomes

1

Correlate in utero adaptations in early and late IUGR, to infant and early childhood neurodevelopment

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.

Time frame
Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
2

Correlate in utero adaptations in early and late IUGR, to infant and early childhood cardiovascular outcomes

Assess cardiovascular health via heart ultrasound after birth

Time frame
Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
3

Correlate in utero adaptations in early and late IUGR, to infant and early childhood metabolic outcomes

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.

Time frame
Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
4

Compare early IUGR, late IUGR and SGA infant and early childhood outcomes

Using the tests describe above compare the outcomes of each group after birth.

Time frame
Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

The Perelman Family Foundation

Collaborator

Source ClinicalTrials.gov
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