MRI Assessment of Placental Health

NCT ID: NCT02297724

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2028-09-30

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

Conditions

Intrauterine Growth Restriction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Oxygen

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Massachusetts Institute of Technology

OTHER

Sponsor Role: collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

Madrid-MIT M+Visión Consortium

UNKNOWN

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ellen Grant

Director, Fetal-Neonatal Neuroimaging and Developmental Science Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia E Grant, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Hospital Universitario de Fuenlabrada

Madrid, , Spain

Site Status: RECRUITING

Countries

United States; Spain

Facility Contacts

Patricia E Grant, MD

Role: primary

ellen.grant@childrens.harvard.edu

857-218-5111

Maria Teulon Gonzalez, MD PhD

Role: primary

maria.teulon@salud.madrid.org

916006252

Other Identifiers

R01EB017337-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHB_Placenta2013

Identifier Type: -

Identifier Source: org_study_id