UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation about transition of placental blood flow in conservative management of placenta accreta
Title of the study (Brief title)	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	Ikuo Konishi
Organization	Kyoto University Graduate School of Medicine
Division name	Obstetrics and Gynecology
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	Kaoru Kawasaki
Organization	Kyoto University Graduate School of Medicine
Division name	Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 01 Day
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

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Publication of results	Unpublished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