Recruiting

Observational StudyLongitudinal Study of Intra-Uterine Growth Restriction

Sponsor:

University of Colorado, Denver

Code:

NCT02382601

Conditions

IUGR

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Ultrasound

MRI

Blood collection

Neurological Function Assessment

Placental Analysis

Study Details

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

Study ID

NCT02382601

Start date

Apr, 2015

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

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).

Interventions

Ultrasound

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

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

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

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

Placentas will undergo pathological evaluation for placental function.

Measurement of body fat

The baby's body fat will be measured in a special incubator called a PEAPOD or BODPOD when an infant.

Pediatric heart ultrasound

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

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 and Locations

Central contacts

Emma Peek, BS

emma.peek@cuanschutz.edu

Locations

University of Colorado Denver Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Emma Peek, BS

emma.peek@cuanschutz.edu

Principal Investigator:

John Hobbins, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

Pregnancy
IUGR
Small for gestational age

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-06-11.