NCT02382601

Longitudinal Study of Intra-Uterine Growth Restriction

Longitudinal Study of Intra-Uterine Growth Restriction (IUGR)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• IUGR
• Pregnancy

Interventions

Type	Name	Description
RADIATION	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.
RADIATION	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.
PROCEDURE	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.
BEHAVIORAL	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.
PROCEDURE	Placental Analysis	Placentas will undergo pathological evaluation for placental function.
PROCEDURE	Measurement of body fat	The baby's body fat will be measured in a special incubator called a PEAPOD or BODPOD when an infant.
RADIATION	Pediatric heart ultrasound	Children will have ultrasounds of their hearts during follow-up visits.

Timeline

• Start date: 2015-04-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2015-03-09
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States