UMIN-CTR Clinical Trial

Basic information
Public title	Study of fetal MRI for evaluating fetal structure and function.
Acronym	Assessment of fetal structure and function by MRI
Scientific Title	Study of fetal MRI for evaluating fetal structure and function.
Scientific Title:Acronym	Assessment of fetal structure and function by MRI
Region	Japan

Condition
Condition	Pregnant woman
Classification by specialty	Obsterics and gynecology Pediatrics Laboratory medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate fetal MRI for predicting fetal structures and functions.
Basic objectives2	Others
Basic objectives -Others	detection rate
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Perinatal outcome
Key secondary outcomes	Association between prenatal ultrasonography and fetal MRI

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	MRI
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	more than 16 weeks of gestation more than one criterion listed below: detailed examination for fetus detailed examination for mother
Key exclusion criteria	The person who do not give one's informed consent The person whom the resercher decide as being not matched to this study
Target sample size	150

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Masahiko Nakata
Organization	Toho University Omori Medical Center
Division name	Department of Obstetrics and Gynecology
Zip code
Address	6-11-1 Omorinishi, Ota-ku, Tokyo, 1430015, Japan
TEL	03-3762-4151
Email	masahiko.nakata@med.toho-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Masahiko Nakata
Organization	Toho University Omori Medical Center
Division name	Department of Obstetrics and Gynecology
Zip code
Address	6-11-1 Omorinishi, Ota-ku, Tokyo, 1430015, Japan
TEL	03-3762-4151
Homepage URL
Email	masahiko.nakata@med.toho-u.ac.jp

Sponsor
Institute	Toho University Omori Medical Center
Institute
Department

Funding Source
Organization	Toho University Omori Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東邦大学医療センター大森病院

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 11 Day
Date of IRB	2017 Year 04 Month 11 Day
Anticipated trial start date	2017 Year 04 Month 11 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 04 Month 11 Day
Last modified on	2019 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030906