Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2016-07-31
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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60 minute research full MRI scan
Pregnant women who are able to have an MRI are eligible for the 60 minute research full MRI scan. Pregnant women may have a healthy pregnancy, a concern for fetal/placental abnormalities with a clinical fetal MRI ordered by their doctor, or a concern for fetal/placental abnormalities without a clinical fetal MRI ordered by their doctor.
The investigational MRI coil designed for pregnant women and research MRI sequences will be tested during the 60 minute research scan.
Investigational MRI coil designed for pregnant women
The investigational MRI receiver coil designed specifically for pregnant women will be used during the 60 minute full research MRI scan. An MRI receiver coil is part of the MRI machine that is placed over the body part being imaged during every MRI scan. A coil is required to obtain MR images, yet there isn't one designed for pregnant women. This investigational MRI receiver coil for pregnant women will be tested to see if it helps improve image quality and take images faster.
MRI Scan
All participants will participate in an MRI scan. The add-on MRI scan will be 15 minutes. The full MRI scan will be 60 minutes.
15 minute research add-on MRI scan
Pregnant women with a concern for fetal/placental abnormalities with a clinical fetal MRI at Boston Children's Hospital are eligible for the 15 minute research add-on MRI scan.
The research MRI sequences will also be tested during the add-on research MRI scan.
MRI Scan
All participants will participate in an MRI scan. The add-on MRI scan will be 15 minutes. The full MRI scan will be 60 minutes.
Interventions
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Investigational MRI coil designed for pregnant women
The investigational MRI receiver coil designed specifically for pregnant women will be used during the 60 minute full research MRI scan. An MRI receiver coil is part of the MRI machine that is placed over the body part being imaged during every MRI scan. A coil is required to obtain MR images, yet there isn't one designed for pregnant women. This investigational MRI receiver coil for pregnant women will be tested to see if it helps improve image quality and take images faster.
MRI Scan
All participants will participate in an MRI scan. The add-on MRI scan will be 15 minutes. The full MRI scan will be 60 minutes.
Eligibility Criteria
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Inclusion Criteria
* Gestational age between 18 and 40 weeks
* AND
* Pregnant women with a healthy pregnancy
* OR
* Pregnant women with a concern for fetal/placental abnormalities referred for a clinical fetal MRI by their obstetrician
* OR
* Pregnant women with a concern for fetal/placental abnormalities NOT referred for a clinical fetal MRI by their obstetrician
* 15 Minute Add-On Research Scan:
* Gestational age between 18 and 40 weeks
* AND
* Pregnant women with a concern for fetal abnormalities referred for a clinical fetal MRI by their obstetrician
* AND
* The clinical fetal MRI will occur at Boston Children's Hospital
Exclusion Criteria
* Pregnant women who are claustrophobic
* Pregnant women who are medically unstable for an MRI
18 Years
45 Years
FEMALE
Yes
Sponsors
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Massachusetts Institute of Technology
OTHER
Massachusetts General Hospital
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Ellen Grant
Professor
Principal Investigators
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P. Ellen Grant, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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