MRI Assessment of Placental Health

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorBoston Children's Hospital

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Proven singleton gestation

Growth restriction of fetus (<10 percentile of norm)

Disqualifiers

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.

Mothers with contraindication to MRI (with pacemaker, metal in body, oversize).

Trial 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

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Oxygen

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: all subjects1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

Massachusetts General Hospital

Collaborator

Massachusetts Institute of Technology

Collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Madrid-MIT M+Visión Consortium

Collaborator