UMIN-CTR Clinical Trial

Basic information
Public title	Placental function evaluation focusing on placental blood flow and oxygenation by imaging, mainly non-contrasted placental MRI in pregnant women
Acronym	Evaluation of placental function by non-contrast enhanced MRI in pregnant women
Scientific Title	Placental function evaluation focusing on placental blood flow and oxygenation by imaging, mainly non-contrasted placental MRI in pregnant women
Scientific Title:Acronym	Evaluation of placental function by non-contrast enhanced MRI in pregnant women
Region	Japan

Condition
Condition	Fetal Growth Restriction
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify placental functions that cause fetal growth failure using non-contrast enhanced MRI.
Basic objectives2	Others
Basic objectives -Others	Clarify BOLD value.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maximum BOLD value during shooting period
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Non-contrast-enhanced MRI is performed in the second trimester (20 to 28 weeks) and late (29 to 37 weeks).
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	45 years-old >=
Gender	Female
Key inclusion criteria	(1)Pregnant women who do not judge that the doctor is incompatible 1.The umbilical cord attachment is lateral 2.The umbilical cord attachment is marginal 3.The mother has pregnancy-induced hypertension syndrome 4.The mother has gestational diabetes 5.Unknown cause of fetal growth restriction (2) Pregnancy 20 weeks or more and less than 37 weeks (3) For pregnant women, the expected delivery date is determined according to the Gynecology and Obstetrics Practice Guidelines-Obstetrics Edition 2014. (4) Informed consent has been obtained from the person (maternal) regarding participation in the test
Key exclusion criteria	Patients who are judged inappropriate by the Principal Investigator or Research Investigator as study subjects.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tomoaki Middle name Last name Ikeda
Organization	Mie University Hospital
Division name	Obstetrics and gynecology
Zip code	5148507
Address	2-174 Edobashi, Tsu City, Mie
TEL	059-232-1111
Email	t-ikeda@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	1st name masafumi Middle name Last name nii
Organization	Mie University Hospital
Division name	Obstetrics and gynecology
Zip code	5148507
Address	2-174 Edobashi, Tsu City, Mie
TEL	059-232-1111
Homepage URL
Email	tadafer.study@gmail.com

Sponsor
Institute	Mie University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Mie University Hospital
Address	2-174 Edobashi, Tsu City, Mie
Tel	059-232-1111
Email	tadafer.study@gmail.com

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

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 20 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	Enrolling by invitation
Date of protocol fixation	2017 Year 06 Month 19 Day
Date of IRB	2017 Year 09 Month 15 Day
Anticipated trial start date	2017 Year 10 Month 17 Day
Last follow-up date	2020 Year 12 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	2020 Year 02 Month 20 Day
Last modified on	2020 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045093