UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022429 |
|---|---|
| Receipt number | R000025660 |
| Scientific Title | Assessment of cardiac function with image inspection for pregnant women |
| Date of disclosure of the study information | 2016/05/24 |
| Last modified on | 2018/11/19 14:00:23 |
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Basic information
Public title
Assessment of cardiac function with image inspection for pregnant women
Acronym
Assessment of cardiac function with image inspection for pregnant women
Scientific Title
Assessment of cardiac function with image inspection for pregnant women
Scientific Title:Acronym
Assessment of cardiac function with image inspection for pregnant women
Region
| Japan |
Condition
Condition
women with normal pregnancy
Classification by specialty
| Cardiology | Obstetrics 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
| 1st name | |
| Middle name | |
| Last name | Tomoaki Ikeda |
Organization
Mie University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174 Edobashi, Tsu, Mie, JAPAN
TEL
059-232-1111
mayu-o@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Nii |
Organization
Mie University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174 Edobashi, Tsu, Mie, JAPAN
TEL
059-232-1111
Homepage URL
mayu-o@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Department of Obstetrics and Gynecology
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2015 | Year | 02 | Month | 05 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025660
