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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035592
Receipt No. R000040534
Scientific Title Maternal and neonatal prognosis of twin-twin transfusion syndrome following fetoscopic laser photocoagulation in monochorionic twin pregnancy.
Date of disclosure of the study information 2019/02/01
Last modified on 2019/01/19

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Basic information
Public title Maternal and neonatal prognosis of twin-twin transfusion syndrome following fetoscopic laser photocoagulation in monochorionic twin pregnancy.
Acronym fetoscopic laser photocoagulation in monochorionic twin pregnancy.
Scientific Title Maternal and neonatal prognosis of twin-twin transfusion syndrome following fetoscopic laser photocoagulation in monochorionic twin pregnancy.
Scientific Title:Acronym fetoscopic laser photocoagulation in monochorionic twin pregnancy.
Region
Japan

Condition
Condition twin-twin transfusion syndrome
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The clinical outcomes of fetoscopic laser photocoagulation in twin-twin transfusion syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The maternal and fetal clinical outcomes of fetoscopic laser photocoagulation in twin-twin transfusion syndrome.
Key secondary outcomes A clinical course of fetus complicated with right ventricular outflow tract obstruction in twin-twin transfusion syndrome.
Examination of amniofluid biochemical marker in recipient fetus at laser therapy.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
15 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria twin-twin transfusion syndrome
Key exclusion criteria none
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Sugino
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address Minamikogushi 1-1-1, Ube, 755-8505, Japan
TEL 0836222288
Email sugino@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Susumu Murata
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address Minamikogushi 1-1-1, Ube, 755-8505, Japan
TEL 0836-22-2288
Homepage URL
Email smurata@yamaguchi-u.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Government offices of other countries
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
2019 Year 02 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2019 Year 02 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 none

Management information
Registered date
2019 Year 01 Month 19 Day
Last modified on
2019 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040534

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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