UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The local injection treatment of methotrexate (MTX) for the placenta accreta
Title of the study (Brief title)	MTX local injection for the placenta accreta
Region	Japan

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

Objectives
Narrative objectives1	We clarify the safety and efficacy of MTX local injection treatment for placenta accreta.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reduction of the blood loss during hepatectomy.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	local injection treatment of MTX
Interventions/Control_2	control
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	50 years-old >=
Gender	Female
Key inclusion criteria	The pregnancy women with placenta accreta
Key exclusion criteria	The pregnancy women with placenta accrete undergone cesarean delivery with hysterectomy.
Target sample size	20

Research contact person
Name of lead principal investigator	Mamoru Morikawa
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Obstetrics
Address	Kita-ku N15 W7, Sapporo 060-8638, Japan
TEL	011-706-6051
Email	mmamoru@med.hokudai.ac.jp

Public contact
Name of contact person	Mamoru Morikawa
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Obstetrics
Address	Kita-ku N15 W7, Sapporo 060-8638, Japan
TEL	011-706-6051
Homepage URL
Email	mmamoru@med.hokudai.ac.jp

Sponsor
Institute	Department of Obstetrics, Hokkaido University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Obstetrics, Hokkaido 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 05 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 20 Day
Anticipated trial start date	2014 Year 06 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 15 Day
Last modified on	2016 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016266