UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of cardiac function with image inspection for pregnant women
Title of the study (Brief title)	Assessment of cardiac function with image inspection for pregnant women
Region	Japan

Condition
Condition	women with normal pregnancy
Classification by specialty	Cardiology Obsterics and gynecology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the change of cardiac function during pregnancy
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	change of cardiac function with pregnant women
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 Other
Interventions/Control_1	cardiovascular magnetic resonance , echocardiography, blood exam
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	39 years-old >=
Gender	Female
Key inclusion criteria	1)Pregnant women over 20 years old with no complication. 2)Patients who have signed to an approved informed consent.
Key exclusion criteria	1)Patients with obstetric complication. 2)Patients with medical complication. 3)Patients who cannot signed an informed consent. 4)Patients who are difficult to consent.
Target sample size	100

Research contact person
Name of lead principal investigator	Tomoaki Ikeda
Organization	Mie University Graduate School of Medicine
Division name	Department of Obstetrics and Gynecology
Address	2-174 Edobashi, Tsu, Mie, JAPAN
TEL	059-232-1111
Email	mayu-o@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Masafumi Nii
Organization	Mie University Graduate School of Medicine
Division name	Department of Obstetrics and Gynecology
Address	2-174 Edobashi, Tsu, Mie, JAPAN
TEL	059-232-1111
Homepage URL
Email	mayu-o@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University Graduate School of Medicine Department of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization	Mie University Graduate School of Medicine Department of Obstetrics and Gynecology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2016 Year 05 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 05 Day
Anticipated trial start date	2015 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 24 Day
Last modified on	2018 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025660