IUGRNCT02382601
Longitudinal Study of Intra-Uterine Growth Restriction
An observational study of IUGR and Pregnancy, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- What is being tested?
- Ultrasound, MRI and Blood collection
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: University of Colorado School of Medicine is a referral center for women carrying fetuses with IUGR. Care providers routinely evaluate more than 300 patients per year at our outreach sites alone whose fetuses have estimated fetal weights below the 10th percentile. Of these, the investigators will initially enroll 200 patients per year between 24 and 36 weeks over a two-year period.
Who may be able to join
- 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.
Who cannot join
- Patients < 18 years of age, and chromosomal anomalies as identified by regular aneuploidy screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emma Peek, BS contact
United States1 site, 1 recruiting
- Recruiting
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045
Emma Peek, BS, emma.peek@cuanschutz.edu
John Hobbins, MD
About this study
Official title: Longitudinal Study of Intra-Uterine Growth Restriction (IUGR)
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.
Read the 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.
- Being tested
- Ultrasound, MRI, Blood collection, Neurological Function Assessment, Placental Analysis
- Keywords
- Pregnancy, IUGR, Small for gestational age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundRadiation
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.
MRIRadiation
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 collectionProcedure or surgery
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 AssessmentBehavioural
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 AnalysisProcedure or surgery
Placentas will undergo pathological evaluation for placental function.
Measurement of body fatProcedure or surgery
Also called Peapod, Bodpod
The baby's body fat will be measured in a special incubator called a PEAPOD or BODPOD when an infant.
Pediatric heart ultrasoundRadiation
Children will have ultrasounds of their hearts during follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Radiation: Ultrasound; Radiation: MRI; Procedure: Blood collection; Behavioral: Neurological Function Assessment; Procedure: Placental Analysis; Procedure: Measurement of body fat; Radiation: Pediatric heart ultrasound | |
| 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). Receives: Radiation: Ultrasound; Radiation: MRI; Procedure: Blood collection; Behavioral: Neurological Function Assessment; Procedure: Placental Analysis; Procedure: Measurement of body fat; Radiation: Pediatric heart ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the sequence of neurological and cardiovascular events defining early and late IUGR pathogenesis, respectively
Using ultrasound and MRI to identify changes in the fetal vasculature, and fetal brain as early and late IUGR progress.
Measured: Every two weeks from the time of IUGR diagnosis or first visit
Secondary outcomes (4)
Correlate in utero adaptations in early and late IUGR, to infant and early childhood neurodevelopment
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.
Measured: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Correlate in utero adaptations in early and late IUGR, to infant and early childhood cardiovascular outcomes
Assess cardiovascular health via heart ultrasound after birth
Measured: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Correlate in utero adaptations in early and late IUGR, to infant and early childhood metabolic outcomes
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.
Measured: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Compare early IUGR, late IUGR and SGA infant and early childhood outcomes
Using the tests describe above compare the outcomes of each group after birth.
Measured: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for IUGRStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- The Perelman Family Foundation
- Responsible party
- Sponsor
- Investigators
- John Hobbins, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382601
- Sponsor's protocol ID
- 14-1360
- Status last verified
- Jun 2026
- First submitted
- 2 Mar 2015
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23969791Mongelli 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.
PubMed 8885925Cruz-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.
PubMed 20435282Hecher 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.
PubMed 11844190Ferrazzi 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.
PubMed 11876805Turan 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.
PubMed 21465604Acharya 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.
PubMed 23775904Kiserud 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.
PubMed 23893598Odibo 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.
PubMed 21324404Hafner 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.
PubMed 23890468Egana-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.
PubMed 23583839Figueras 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.
PubMed 21557369Eixarch 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.
PubMed 19035538Fowlkes 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.
PubMed 10680613Torloni 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.
PubMed 19291813
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Intra-Uterine Growth Restriction (IUGR)
- ClinicalTrials.gov ID
- NCT02382601
- Acronym / sponsor ID
- 14-1360
- Keywords
- Pregnancy, IUGR, Small for gestational age
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- The Perelman Family Foundation
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small for Gestational Age Pregancies (controls) | – | Radiation: Ultrasound, Radiation: MRI, Procedure: Blood collection, Behavioral: Neurological Function Assessment, Procedure: Placental Analysis, Procedure: Measurement of body fat, Radiation: Pediatric heart ultrasoundSmall 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) | – | Radiation: Ultrasound, Radiation: MRI, Procedure: Blood collection, Behavioral: Neurological Function Assessment, Procedure: Placental Analysis, Procedure: Measurement of body fat, Radiation: Pediatric heart ultrasoundSmall 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- University of Colorado School of Medicine is a referral center for women carrying fetuses with IUGR. Care providers routinely evaluate more than 300 patients per year at our outreach sites alone whose fetuses have estimated fetal weights below the 10th percentile. Of these, the investigators will initially enroll 200 patients per year between 24 and 36 weeks over a two-year period.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients < 18 years of age, and chromosomal anomalies as identified by regular aneuploidy screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundWith 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 | IUGR Pregnancies (cases), Small for Gestational Age Pregancies (controls) |
| MRISimilar 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. | Radiation | IUGR Pregnancies (cases), Small for Gestational Age Pregancies (controls) |
| Blood collectionThe 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. | Procedure or surgery | IUGR Pregnancies (cases), Small for Gestational Age Pregancies (controls) |
| Neurological Function AssessmentNeurological development tests including a Bayley exam, Mullen exam, Developmental Profile-3, Child Behavior Checklist, and Pediatric Stroke Outcome Measure (PSOM) will be performed. | Behavioural | IUGR Pregnancies (cases), Small for Gestational Age Pregancies (controls) |
| Placental AnalysisPlacentas will undergo pathological evaluation for placental function. | Procedure or surgery | IUGR Pregnancies (cases), Small for Gestational Age Pregancies (controls) |
| Measurement of body fatAlso: Peapod, BodpodThe baby's body fat will be measured in a special incubator called a PEAPOD or BODPOD when an infant. | Procedure or surgery | IUGR Pregnancies (cases), Small for Gestational Age Pregancies (controls) |
| Pediatric heart ultrasoundChildren will have ultrasounds of their hearts during follow-up visits. | Radiation | IUGR Pregnancies (cases), Small for Gestational Age Pregancies (controls) |
Primary outcome
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
Using ultrasound and MRI to identify changes in the fetal vasculature, and fetal brain as early and late IUGR progress.
4 secondary outcomes
Correlate in utero adaptations in early and late IUGR, to infant and early childhood neurodevelopment
Time frame: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Correlate in utero adaptations in early and late IUGR, to infant and early childhood cardiovascular outcomes
Time frame: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Correlate in utero adaptations in early and late IUGR, to infant and early childhood metabolic outcomes
Time frame: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Compare early IUGR, late IUGR and SGA infant and early childhood outcomes
Time frame: Baseline (Day 0), 40-44 weeks gestational age (post-birth), 6 months, 1-7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 23969791Barker 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.
- Background: PubMed 8885925Mongelli 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.
- Background: PubMed 20435282Cruz-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.
- Background: PubMed 11844190Hecher 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.
- Background: PubMed 11876805Ferrazzi 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.
- Background: PubMed 21465604Turan 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.
- Background: PubMed 23775904Acharya 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.
- Background: PubMed 23893598Kiserud 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.
- Background: PubMed 21324404Odibo 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.
- Background: PubMed 23890468Hafner 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.
- Background: PubMed 23583839Egana-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.
- Background: PubMed 21557369Figueras 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emma Peek, BS contact
John Hobbins, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IUGR and Pregnancy, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Peek, BS (emma.peek@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02382601, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.