UMIN-CTR Clinical Trial

Basic information
Public title	Observational study on changes in uterine artery blood flow and placental oxygen concentration during maternal medication using MRI
Acronym	Observational study on changes in uterine artery blood flow and placental oxygen concentration using MRI
Scientific Title	Observational study on changes in uterine artery blood flow and placental oxygen concentration during maternal medication using MRI
Scientific Title:Acronym	Observational study on changes in uterine artery blood flow and placental oxygen concentration using MRI
Region	Japan

Condition
Condition	Pregnant women with conditions mainly due to placental abnormalities such as preeclampsia or fetal growth restriction
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to measure the blood flow of the uterine artery before and after drug administration, evaluate the effect of the drug on the placenta, and clarify the effect on the fetus.
Basic objectives2	Others
Basic objectives -Others	Correlation between birth weight, delivery weeks and changes in BOLD signal and uterine artery blood flow Correlation between placental histopathology (pathological image, evaluation of oxygenation by immunostaining) and changes in BOLD signal and uterine artery blood flow
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes and trends in BOLD signal before and after administration of drugs that may affect hemodynamics. Changes and trends in uterine artery blood flow.
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	After obtaining consent for singleton pregnancy after 20 weeks of gestation, when a drug that may affect the hemodynamics is newly administered, a uteroplacental MRI will be taken immediately before drug administration. Uterine placenta MRI is performed on the same subject as the first imaging after administration of the drug within 7 days after the first imaging.
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. Singleton pregnancy between the ages of 20 and 45 2. Pregnant women who receive new drugs that may affect hemodynamics 3. 20 weeks or more of pregnancy 4. Informed consent has been obtained from the person (maternal) regarding the participation in the research
Key exclusion criteria	If consent cannot be obtained after sufficient informed consent. When the mother has signs of premature birth.
Target sample size	20

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	514-8507
Address	2-174 Edobashi, Tsu City, Mie
TEL	0592321111
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	514-8507
Address	2-174 Edobashi, Tsu City, Mie
TEL	0592321111
Homepage URL
Email	tadafer.study@gmail.com

Sponsor
Institute	Mie University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Mie University Hospital
Address	Mie University Hospital
Tel	0592321111
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	2018 Year 12 Month 06 Day
Date of IRB	2019 Year 05 Month 18 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2021 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=R000045102