UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intrauterine fetal blood transfusion for fetal anemia
Title of the study (Brief title)	fetal blood transfusion
Region	Japan

Condition
Condition	fetal anemia
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Intrauterine fetal therapy for fetal anemia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Improvement of the fetal anemia
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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Puncture
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Fetal anemia
Key exclusion criteria	The fetus has a severe congenital abnormalities. The patient does not agree with this therapy.
Target sample size	10

Research contact person
Name of lead principal investigator	TSUDA HIROYUKI
Organization	Nagoya University
Division name	Obstetrics and Gynecology
Address	Tsurumai-cho 65, Showa-ku, Nagoya
TEL	052-744-2261
Email	hiro-t@med.nagoya-u.ac.jp

Public contact
Name of contact person	TSUDA HIROYUKI
Organization	Nagoya University
Division name	Obstetrics and Gynecology
Address	Tsurumai-cho 65, Showa-ku, Nagoya
TEL	052-744-2261
Homepage URL
Email	hiro-t@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya University
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	2015 Year 03 Month 24 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 03 Month 24 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 03 Month 27 Day
Date of closure to data entry	2017 Year 03 Month 27 Day
Date trial data considered complete	2017 Year 03 Month 27 Day
Date analysis concluded	2017 Year 03 Month 27 Day

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Publication of results	Unpublished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

Management information
Registered date	2015 Year 03 Month 24 Day
Last modified on	2017 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019613