Longitudinal Study of Intra-Uterine Growth Restriction

Recruiting

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

• Registration Number: NCT02382601
• Lead Sponsor: University of Colorado, Denver

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.

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.

Study Timeline

• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-09
• Study Start: 2015-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Small for Gestational Age Pregancies (controls)	Ultrasound	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)	Placental Analysis	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).
Small for Gestational Age Pregancies (controls)	MRI	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).
Small for Gestational Age Pregancies (controls)	Blood collection	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).
Small for Gestational Age Pregancies (controls)	Measurement of body fat	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).
Small for Gestational Age Pregancies (controls)	Placental Analysis	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).
Small for Gestational Age Pregancies (controls)	Pediatric heart ultrasound	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)	Ultrasound	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).
IUGR Pregnancies (cases)	Blood collection	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).
IUGR Pregnancies (cases)	Pediatric heart ultrasound	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).
Small for Gestational Age Pregancies (controls)	Neurological Function Assessment	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)	MRI	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).
IUGR Pregnancies (cases)	Measurement of body fat	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).
IUGR Pregnancies (cases)	Neurological Function Assessment	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).

Primary Outcome Measures

Name	Time	Method
Characterize the sequence of neurological and cardiovascular events defining early and late IUGR pathogenesis, respectively	Every two weeks from the time of IUGR diagnosis or first visit	Using ultrasound and MRI to identify changes in the fetal vasculature, and fetal brain as early and late IUGR progress.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	Assess cardiovascular health via heart ultrasound after birth
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	Using the tests describe above compare the outcomes of each group after birth.
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	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.

Trial Locations

Locations (1)

University of Colorado Denver Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States