Longitudinal Study of Intra-Uterine Growth Restriction

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: IUGR; Pregnancy

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

Study type: Observational

Funder types: Other

Identifiers

NCT02382601

14-1360

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Small for Gestational Age Pregancies (controls)

Description:

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).

Treatment:

Radiation: Ultrasound

Radiation: Pediatric heart ultrasound

Procedure: Measurement of body fat

Radiation: MRI

Procedure: Blood collection

Behavioral: Neurological Function Assessment

Procedure: Placental Analysis

IUGR Pregnancies (cases)

Description:

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).

Treatment:

Radiation: Ultrasound

Radiation: Pediatric heart ultrasound

Procedure: Measurement of body fat

Radiation: MRI

Procedure: Blood collection

Behavioral: Neurological Function Assessment

Procedure: Placental Analysis