Skip to content

MRI Assessment of Placental Health

MRI Assessment of Placental Health

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02297724
Enrollment
80
Registered
2014-11-21
Start date
2014-04-30
Completion date
2028-09-30
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Growth Restriction

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

Interventions

OTHEROxygen

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.

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
Massachusetts Institute of Technology
CollaboratorOTHER
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
CollaboratorNIH
Madrid-MIT M+Visión Consortium
CollaboratorUNKNOWN
Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
BOLD MRI signal change during maternal oxygen exposure in placenta and fetus30 min during the 1 hour scan
placental volume on MRI image5 min during 1 hour scan

Secondary

MeasureTime frame
pathological reports of placenta after delivery1 day
fetal growth curve after birthup to 6 month

Countries

Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026