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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014051
Receipt No. R000016358
Scientific Title Investigation about transition of placental blood flow in conservative management of placenta accreta
Date of disclosure of the study information 2014/07/01
Last modified on 2017/03/28

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Basic information
Public title Investigation about transition of placental blood flow in conservative management of placenta accreta
Acronym Investigation about transition of placental blood flow in conservative management of placenta accreta
Scientific Title Investigation about transition of placental blood flow in conservative management of placenta accreta
Scientific Title:Acronym Investigation about transition of placental blood flow in conservative management of placenta accreta
Region
Japan

Condition
Condition placenta accreta
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of this research are investigation of placental blood flow and its evaluation methods in conservative management of placenta accreta, and verification of efficacy and safety of conservative management.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes volume of placental blood flow
serum hCG
Key secondary outcomes

Base
Study type

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 Treatment
Type of intervention
Device,equipment Other
Interventions/Control_1 Evaluation of placental blood flow by color doppler ultrasonography
Evaluation of volume of placental blood flow by magnetic resonance imaging
Measurement of serum hCG
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria The patients who were diagnosed with placenta accreta and recieved conservative management.
Key exclusion criteria none
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuo Konishi
Organization Kyoto University Graduate School of Medicine
Division name Obstetrics and Gynecology
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo, Kyoto,606-8507, Japan
TEL 075-751-3269
Email konishi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaoru Kawasaki
Organization Kyoto University Graduate School of Medicine
Division name Obstetrics and Gynecology
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo, Kyoto,606-8507, Japan
TEL 075-751-3269
Homepage URL
Email kkaoru@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kyoto University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 01 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
2014 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 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
2014 Year 05 Month 23 Day
Last modified on
2017 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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