Intrauterine Growth RestrictionNCT02297724
MRI Assessment of Placental Health
An observational study of Intrauterine Growth Restriction, run by Boston Children's Hospital at 2 sites in 2 countries.
Trial summary
The ultimate goal of this project is to develop methods that allow informed decision-making on the delivery time of fetuses that are at increased risk of stillbirth due to IUGR. In placenta related IUGR pregnancies, there can be multiple concurrent placental pathologies. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Growth Restriction
- What is being tested?
- Oxygen
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2014to Sep 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
- Healthy volunteers accepted
- Adult
Study population: * pregnant mothers with twin gestation with diagnosis of selective IUGR * pregnant mothers with singleton gestation with diagnosis of IUGR * singleton pregnant mothers and twin pregnant mothers with no apparent medical complication on fetuses
Who may be able to join
- The pregnant mother with twin gestation with diagnosis of selective IUGR based upon obstetrical US findings as following:
- Proven monochorionicity / dichorionicity
- Discordance in estimated fetal weight (EFW). Growth restriction (<10 percentile of norm) in one or both fetus(es) AND/OR growth discordance (> or = 20%) between twin fetuses.
- The pregnant mother with singleton gestation with diagnosis of IUGR based upon obstetrical US findings as following:
- Proven singleton gestation
- Growth restriction of fetus (<10 percentile of norm)
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- Doppler measurements that indicates placental insufficiency: umbilical artery, middle cerebral artery, uterine artery; or oligohydramnios.
- Gestational age: Bigger than 18 weeks.
- Pregnant mother is between age 18 to 45, clinically stable and can safely tolerate fetal MRI study.
Who cannot join
- Fetuses/infants with the following features will be excluded.
- Fetus/infant with chromosomal anomalies or known genetic disorders.
- Fetus/infant with other major congenital malformation.
- Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient, quality or completeness of the data.
- Pregnant mothers with the following features will be excluded.
- Mothers with contraindication to MRI (with pacemaker, metal in body, oversize).
- Mothers with claustrophobia
- Mothers medically unstable for the MRI study
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Patricia E Grant, MD, 857-218-5111, ellen.grant@childrens.harvard.edu
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Fuenlabrada
Madrid, 28942
Maria Teulon Gonzalez, MD PhD, 916006252, maria.teulon@salud.madrid.org
About this study
The ultimate goal of this project is to develop methods that allow informed decision-making on the delivery time of fetuses that are at increased risk of stillbirth due to IUGR. In placenta related IUGR pregnancies, there can be multiple concurrent placental pathologies. Although there is no specific correspondence between a single type of pathology and IUGR, the common result of these pathologies is placental insufficiency, which limits the maternal-fetal exchange. Oxygen and nutrition transport is known to be hindered in IUGR placentas due to obstructed or abrupt vasculature, massive fibrin deposition, and inflammation in the villous and intervillous space (villitis). Thus one potential approach to distinguish IUGR pregnancies from normal ones is to assess the efficiency of placental transport. Based on the hypothesis that efficiency of oxygen transport is representative for overall oxygen and nutrition transport in placenta, the investigators propose to characterize the blood oxygenation and blood perfusion in placenta in vivo via MRI, and use it as an index for better stratification in the IUGR risk group. The investigators will also consider alternative MRI approaches such as structural, diffusion and spectroscopy measurements inside the placenta, which might reflect the state of placental transport and reveal the status of placental health.
Specific aims: 1) To correlate the MRI metrics that differentiate placental insufficiency from normal placenta transport with histopathology data of the placenta. 2) To correlate the MRI metrics that reflects placental insufficiency with fetal outcome
- Conditions
- Intrauterine Growth Restriction
- Being tested
- Oxygen
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenOther
Administration of oxygen will last for no more than 10 min, with flow rate 15L/min via non-rebreather facial mask. Each subject will have once of the administration per scan.
| Study group | Role | What they receive |
|---|---|---|
| all subjects | For all subjects, administration of oxygen will last for no more than 10 min, with flow rate 15L/min via non-rebreather facial mask. Each subject will have once of the administration per scan. Data collection will start about 10 min before the administration of oxygen, and last throughout the oxygen exposure, then continue for about 10 min after oxygen exposure for each subject. Receives: Other: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD MRI signal change during maternal oxygen exposure in placenta and fetus
Measured: 30 min during the 1 hour scan
placental volume on MRI image
Measured: 5 min during 1 hour scan
Secondary outcomes (2)
pathological reports of placenta after delivery
Measured: 1 day
fetal growth curve after birth
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Massachusetts Institute of Technology, National Institute for Biomedical Imaging and Bioengineering (NIBIB), Madrid-MIT M+Visión Consortium
- Responsible party
- Principal investigator, Ellen Grant, Boston Children's Hospital
- Investigators
- Patricia E Grant, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297724
- Sponsor's protocol ID
- CHB_Placenta2013
- Other IDs
- R01EB017337-01
- Status last verified
- Dec 2025
- First submitted
- 15 Oct 2014
- Last updated
- 12 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Assessment of Placental Health
- ClinicalTrials.gov ID
- NCT02297724
- Acronym / sponsor ID
- CHB_Placenta2013
- Conditions
- Intrauterine Growth Restriction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Massachusetts Institute of Technology, National Institute for Biomedical Imaging and Bioengineering (NIBIB), Madrid-MIT M+Visión Consortium
- Study start
- Apr 2014
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 21 Nov 2014 (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 ultimate goal of this project is to develop methods that allow informed decision-making on the delivery time of fetuses that are at increased risk of stillbirth due to IUGR. In placenta related IUGR pregnancies, there can be multiple concurrent placental pathologies. Although there is no specific correspondence between a single type of pathology and IUGR, the common result of these pathologies is placental insufficiency, which limits the maternal-fetal exchange. Oxygen and nutrition transport is known to be hindered in IUGR placentas due to obstructed or abrupt vasculature, massive fibrin deposition, and inflammation in the villous and intervillous space (villitis). Thus one potential approach to distinguish IUGR pregnancies from normal ones is to assess the efficiency of placental transport. Based on the hypothesis that efficiency of oxygen transport is representative for overall oxygen and nutrition transport in placenta, the investigators propose to characterize the blood oxygenation and blood perfusion in placenta in vivo via MRI, and use it as an index for better stratification in the IUGR risk group. The investigators will also consider alternative MRI approaches such as structural, diffusion and spectroscopy measurements inside the placenta, which might reflect the state of placental transport and reveal the status of placental health.
Specific aims: 1) To correlate the MRI metrics that differentiate placental insufficiency from normal placenta transport with histopathology data of the placenta. 2) To correlate the MRI metrics that reflects placental insufficiency with fetal outcome
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all subjects | – | Other: OxygenFor all subjects, administration of oxygen will last for no more than 10 min, with flow rate 15L/min via non-rebreather facial mask. Each subject will have once of the administration per scan. Data collection will start about 10 min before the administration of oxygen, and last throughout the oxygen exposure, then continue for about 10 min after oxygen exposure for each subject. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * pregnant mothers with twin gestation with diagnosis of selective IUGR * pregnant mothers with singleton gestation with diagnosis of IUGR * singleton pregnant mothers and twin pregnant mothers with no apparent medical complication on fetuses
Key inclusion criteria (9 listed)
- The pregnant mother with twin gestation with diagnosis of selective IUGR based upon obstetrical US findings as following:
- The pregnant mother with singleton gestation with diagnosis of IUGR based upon obstetrical US findings as following:
- Gestational age: Bigger than 18 weeks.
- Pregnant mother is between age 18 to 45, clinically stable and can safely tolerate fetal MRI study.
Key exclusion criteria (8 listed)
- Fetuses/infants with the following features will be excluded.
- Fetus/infant with chromosomal anomalies or known genetic disorders.
- Fetus/infant with other major congenital malformation.
- Presence of any condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient, quality or completeness of the data.
- Pregnant mothers with the following features will be excluded.
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 |
|---|---|---|
| OxygenAdministration of oxygen will last for no more than 10 min, with flow rate 15L/min via non-rebreather facial mask. Each subject will have once of the administration per scan. | Other | all subjects |
Primary outcome
BOLD MRI signal change during maternal oxygen exposure in placenta and fetus
Time frame: 30 min during the 1 hour scan
placental volume on MRI image
Time frame: 5 min during 1 hour scan
2 secondary outcomes
pathological reports of placenta after delivery
Time frame: 1 day
fetal growth curve after birth
Time frame: up to 6 month
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 12 Dec 2025.
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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.
Patricia E Grant, MD principal investigator
Boston Children's Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Growth Restriction, run by Boston Children's Hospital at 2 sites in 2 countries.
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 9 inclusion and 8 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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD MRI signal change during maternal oxygen exposure in placenta and fetus (time frame: 30 min during the 1 hour scan). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2025.