Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02297724

MRI Assessment of Placental Health

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Intrauterine Growth Restriction Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Universitario de Fuenlabrada, Madrid, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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.

Exclusion criteria

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

Treatment and study plan

Oxygen

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.

Primary outcomes

  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 outcomes

  1. pathological reports of placenta after delivery

    Time frame: 1 day

  2. fetal growth curve after birth

    Time frame: up to 6 month

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Madrid-MIT M+Visión Consortium
  • Massachusetts General Hospital
  • Massachusetts Institute of Technology
  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Important dates

Study start
2014
Primary completion
2027
Study completion
2028
First posted
Nov 21, 2014
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.