We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MRI Assessment of Placental Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02297724
Recruitment Status : Recruiting
First Posted : November 21, 2014
Last Update Posted : August 11, 2022
Sponsor:
Collaborators:
Massachusetts General Hospital
Massachusetts Institute of Technology
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Madrid-MIT M+Visión Consortium
Information provided by (Responsible Party):
Ellen Grant, Boston Children's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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


Condition or disease Intervention/treatment
Intrauterine Growth Restriction Other: Oxygen

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: MRI Assessment of Placental Health
Study Start Date : April 2014
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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.
 Other: Oxygen
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. BOLD MRI signal change during maternal oxygen exposure in placenta and fetus [ Time Frame: 30 min during the 1 hour scan ]
  2. placental volume on MRI image [ Time Frame: 5 min during 1 hour scan ]

Secondary Outcome Measures :
  1. pathological reports of placenta after delivery [ Time Frame: 1 day ]
  2. fetal growth curve after birth [ Time Frame: up to 6 month ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  1. 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.

  2. 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)
    • Doppler measurements that indicates placental insufficiency: umbilical artery, middle cerebral artery, uterine artery; or oligohydramnios.
  3. Gestational age: Bigger than 18 weeks.
  4. Pregnant mother is between age 18 to 45, clinically stable and can safely tolerate fetal MRI study.

Exclusion Criteria:

Fetuses/infants with the following features will be excluded.

  1. Fetus/infant with chromosomal anomalies or known genetic disorders.
  2. Fetus/infant with other major congenital malformation.
  3. 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.

  1. Mothers with contraindication to MRI (with pacemaker, metal in body, oversize).
  2. Mothers with claustrophobia
  3. Mothers medically unstable for the MRI study
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297724


Locations
Layout table for location information
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Patricia E Grant, MD    857-218-5111    ellen.grant@childrens.harvard.edu   
Spain
Hospital Universitario de Fuenlabrada Recruiting
Madrid, Spain, 28942
Contact: Maria Teulon Gonzalez, MD PhD    916006252    maria.teulon@salud.madrid.org   
Sponsors and Collaborators
Boston Children's Hospital
Massachusetts General Hospital
Massachusetts Institute of Technology
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Madrid-MIT M+Visión Consortium
Investigators
Layout table for investigator information
Principal Investigator: Patricia E Grant, MD Boston Children's Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ellen Grant, Director, Fetal-Neonatal Neuroimaging and Developmental Science Center, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02297724    
Other Study ID Numbers: CHB_Placenta2013
R01EB017337-01 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: August 11, 2022
Last Verified: August 2022
Additional relevant MeSH terms:
Layout table for MeSH terms
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Growth Disorders
Pathologic Processes