Longitudinal Study of Intra-Uterine Growth Restriction

NCT02382601 | Recruiting

• 1 other identifier: 14-1360
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

IUGR; Pregnancy

Keywords

Pregnancy; IUGR; Small for gestational age

Outcome Measures

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.

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

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

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).

Radiation: Ultrasound; Radiation: MRI; Procedure: Blood collection; Behavioral: Neurological Function Assessment; Procedure: Placental Analysis; Procedure: Measurement of body fat; Radiation: Pediatric heart ultrasound

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).

Radiation: Ultrasound; Radiation: MRI; Procedure: Blood collection; Behavioral: Neurological Function Assessment; Procedure: Placental Analysis; Procedure: Measurement of body fat; Radiation: Pediatric heart ultrasound

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.

IUGR Pregnancies (cases); Small for Gestational Age Pregancies (controls)

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.

IUGR Pregnancies (cases); Small for Gestational Age Pregancies (controls)

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.

IUGR Pregnancies (cases); Small for Gestational Age Pregancies (controls)

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.

IUGR Pregnancies (cases); Small for Gestational Age Pregancies (controls)

Placental Analysis PROCEDURE

Placentas will undergo pathological evaluation for placental function.

IUGR Pregnancies (cases); Small for Gestational Age Pregancies (controls)

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.

Also known as: Peapod, Bodpod

IUGR Pregnancies (cases); Small for Gestational Age Pregancies (controls)

Pediatric heart ultrasound RADIATION

Children will have ultrasounds of their hearts during follow-up visits.

IUGR Pregnancies (cases); Small for Gestational Age Pregancies (controls)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• The Perelman Family Foundation: collaborator

Study Sites (1)

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (27)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal peripheral blood and umbilical cord blood

MeSH Terms

Interventions

High-Energy Shock Waves; Blood Specimen Collection; PEAPOD protein, Arabidopsis

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• John Hobbins, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Peek, BS

CONTACT

emma.peek@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 9, 2015
• Study Start: April 1, 2015
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)