UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035592 |
|---|---|
| Receipt number | 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 | 2023/07/24 16:07:03 |
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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
| Obstetrics 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 | Norihiro |
| Middle name | |
| Last name | Sugino |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
7558505
Address
Minamikogushi 1-1-1, Ube, 755-8505, Japan
TEL
0836222288
sugino@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | murata |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
7558505
Address
Minamikogushi 1-1-1, Ube, 755-8505, Japan
TEL
0836222288
Homepage URL
smurata@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
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
Yamaguchi University Hospital
Address
1-1-1 Minamikogushi
Tel
+81836222288
smurata@yamaguchi-u.ac.jp
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
25
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
| 2018 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2027 | Year | 09 | Month | 30 | Day |
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 01 | Month | 19 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040534
