Study Results
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Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2015-04-30
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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).
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.
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).
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
FEMALE
No
Sponsors
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The Perelman Family Foundation
UNKNOWN
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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John Hobbins, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Barker ED, McAuliffe FM, Alderdice F, Unterscheider J, Daly S, Geary MP, Kennelly MM, O'Donoghue K, Hunter A, Morrison JJ, Burke G, Dicker P, Tully EC, Malone FD. The role of growth trajectories in classifying fetal growth restriction. Obstet Gynecol. 2013 Aug;122(2 Pt 1):248-254. doi: 10.1097/AOG.0b013e31829ca9a7.
Mongelli M, Gardosi J. Reduction of false-positive diagnosis of fetal growth restriction by application of customized fetal growth standards. Obstet Gynecol. 1996 Nov;88(5):844-8. doi: 10.1016/0029-7844(96)00285-2.
Cruz-Martinez R, Figueras F, Hernandez-Andrade E, Puerto B, Gratacos E. Longitudinal brain perfusion changes in near-term small-for-gestational-age fetuses as measured by spectral Doppler indices or by fractional moving blood volume. Am J Obstet Gynecol. 2010 Jul;203(1):42.e1-6. doi: 10.1016/j.ajog.2010.02.049. Epub 2010 May 1.
Hecher K, Bilardo CM, Stigter RH, Ville Y, Hackeloer BJ, Kok HJ, Senat MV, Visser GH. Monitoring of fetuses with intrauterine growth restriction: a longitudinal study. Ultrasound Obstet Gynecol. 2001 Dec;18(6):564-70. doi: 10.1046/j.0960-7692.2001.00590.x.
Ferrazzi E, Bozzo M, Rigano S, Bellotti M, Morabito A, Pardi G, Battaglia FC, Galan HL. Temporal sequence of abnormal Doppler changes in the peripheral and central circulatory systems of the severely growth-restricted fetus. Ultrasound Obstet Gynecol. 2002 Feb;19(2):140-6. doi: 10.1046/j.0960-7692.2002.00627.x.
Turan OM, Turan S, Berg C, Gembruch U, Nicolaides KH, Harman CR, Baschat AA. Duration of persistent abnormal ductus venosus flow and its impact on perinatal outcome in fetal growth restriction. Ultrasound Obstet Gynecol. 2011 Sep;38(3):295-302. doi: 10.1002/uog.9011.
Acharya G. Measurement of atrioventricular annular plane displacement has been revived: will it prove to be useful in assessing fetal cardiac function? Ultrasound Obstet Gynecol. 2013 Aug;42(2):125-9. doi: 10.1002/uog.12542. No abstract available.
Kiserud T. Re: umbilical vein flow and perinatal outcome in term small-for-gestational-age fetuses. M. Parra-Saavedra, F. Crovetto, S. Triunfo, S. Savchev, G. Parra, M. Sanz, E. Gratacos and F. Figueras. Ultrasound Obstet Gynecol 2013; 42: 189-195. Ultrasound Obstet Gynecol. 2013 Aug;42(2):130. doi: 10.1002/uog.12553. No abstract available.
Odibo AO, Zhong Y, Longtine M, Tuuli M, Odibo L, Cahill AG, Macones GA, Nelson DM. First-trimester serum analytes, biophysical tests and the association with pathological morphometry in the placenta of pregnancies with preeclampsia and fetal growth restriction. Placenta. 2011 Apr;32(4):333-8. doi: 10.1016/j.placenta.2011.01.016. Epub 2011 Feb 13.
Hafner E, Metzenbauer M, Stumpflen I, Waldhor T. Measurement of placental bed vascularization in the first trimester, using 3D-power-Doppler, for the detection of pregnancies at-risk for fetal and maternal complications. Placenta. 2013 Oct;34(10):892-8. doi: 10.1016/j.placenta.2013.06.303. Epub 2013 Jul 24.
Egana-Ugrinovic G, Sanz-Cortes M, Figueras F, Bargallo N, Gratacos E. Differences in cortical development assessed by fetal MRI in late-onset intrauterine growth restriction. Am J Obstet Gynecol. 2013 Aug;209(2):126.e1-8. doi: 10.1016/j.ajog.2013.04.008. Epub 2013 Apr 9.
Figueras F, Cruz-Martinez R, Sanz-Cortes M, Arranz A, Illa M, Botet F, Costas-Moragas C, Gratacos E. Neurobehavioral outcomes in preterm, growth-restricted infants with and without prenatal advanced signs of brain-sparing. Ultrasound Obstet Gynecol. 2011 Sep;38(3):288-94. doi: 10.1002/uog.9041. Epub 2011 Aug 10.
Eixarch E, Meler E, Iraola A, Illa M, Crispi F, Hernandez-Andrade E, Gratacos E, Figueras F. Neurodevelopmental outcome in 2-year-old infants who were small-for-gestational age term fetuses with cerebral blood flow redistribution. Ultrasound Obstet Gynecol. 2008 Dec;32(7):894-9. doi: 10.1002/uog.6249.
Fowlkes JB, Holland CK. Mechanical bioeffects from diagnostic ultrasound: AIUM consensus statements. American Institute of Ultrasound in Medicine. J Ultrasound Med. 2000 Feb;19(2):69-72. doi: 10.7863/jum.2000.19.2.69. No abstract available.
Torloni MR, Vedmedovska N, Merialdi M, Betran AP, Allen T, Gonzalez R, Platt LD; ISUOG-WHO Fetal Growth Study Group. Safety of ultrasonography in pregnancy: WHO systematic review of the literature and meta-analysis. Ultrasound Obstet Gynecol. 2009 May;33(5):599-608. doi: 10.1002/uog.6328.
Ang ES Jr, Gluncic V, Duque A, Schafer ME, Rakic P. Prenatal exposure to ultrasound waves impacts neuronal migration in mice. Proc Natl Acad Sci U S A. 2006 Aug 22;103(34):12903-10. doi: 10.1073/pnas.0605294103. Epub 2006 Aug 10.
Salvesen KA, Eik-Nes SH. Ultrasound during pregnancy and subsequent childhood non-right handedness: a meta-analysis. Ultrasound Obstet Gynecol. 1999 Apr;13(4):241-6. doi: 10.1046/j.1469-0705.1999.13040241.x.
Newnham JP, Doherty DA, Kendall GE, Zubrick SR, Landau LL, Stanley FJ. Effects of repeated prenatal ultrasound examinations on childhood outcome up to 8 years of age: follow-up of a randomised controlled trial. Lancet. 2004 Dec 4-10;364(9450):2038-44. doi: 10.1016/S0140-6736(04)17516-8.
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Baker PN, Johnson IR, Harvey PR, Gowland PA, Mansfield P. A three-year follow-up of children imaged in utero with echo-planar magnetic resonance. Am J Obstet Gynecol. 1994 Jan;170(1 Pt 1):32-3. doi: 10.1016/s0002-9378(94)70379-5.
Simon EM, Goldstein RB, Coakley FV, Filly RA, Broderick KC, Musci TJ, Barkovich AJ. Fast MR imaging of fetal CNS anomalies in utero. AJNR Am J Neuroradiol. 2000 Oct;21(9):1688-98.
Runge VM. Safety of approved MR contrast media for intravenous injection. J Magn Reson Imaging. 2000 Aug;12(2):205-13. doi: 10.1002/1522-2586(200008)12:23.0.co;2-p.
Victoria T, Jaramillo D, Roberts TP, Zarnow D, Johnson AM, Delgado J, Rubesova E, Vossough A. Fetal magnetic resonance imaging: jumping from 1.5 to 3 tesla (preliminary experience). Pediatr Radiol. 2014 Apr;44(4):376-86; quiz 373-5. doi: 10.1007/s00247-013-2857-0. Epub 2014 Mar 27.
Savchev S, Figueras F, Cruz-Martinez R, Illa M, Botet F, Gratacos E. Estimated weight centile as a predictor of perinatal outcome in small-for-gestational-age pregnancies with normal fetal and maternal Doppler indices. Ultrasound Obstet Gynecol. 2012 Mar;39(3):299-303. doi: 10.1002/uog.10150. Epub 2012 Feb 7.
Chawengsettakul S, Russameecharoen K, Wanitpongpan P. Fetal cardiac function measured by myocardial performance index of small-for-gestational age fetuses. J Obstet Gynaecol Res. 2015 Feb;41(2):222-8. doi: 10.1111/jog.12508. Epub 2014 Aug 27.
Mailath-Pokorny M, Worda K, Schmid M, Polterauer S, Bettelheim D. Isolated single umbilical artery: evaluating the risk of adverse pregnancy outcome. Eur J Obstet Gynecol Reprod Biol. 2015 Jan;184:80-3. doi: 10.1016/j.ejogrb.2014.11.007. Epub 2014 Nov 20.
Other Identifiers
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14-1360
Identifier Type: -
Identifier Source: org_study_id
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