UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054874 |
|---|---|
| Receipt number | R000062697 |
| Scientific Title | Evaluation of fetal hemodynamic status to elucidate the pathogenesis of monochorionic twin complications |
| Date of disclosure of the study information | 2024/07/03 |
| Last modified on | 2024/07/03 21:09:38 |
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Basic information
Public title
Evaluation of fetal hemodynamic status to elucidate the pathogenesis of monochorionic twin complications
Acronym
Evaluation of fetal hemodynamic status to elucidate the pathogenesis of monochorionic twin complications
Scientific Title
Evaluation of fetal hemodynamic status to elucidate the pathogenesis of monochorionic twin complications
Scientific Title:Acronym
Evaluation of fetal hemodynamic status to elucidate the pathogenesis of monochorionic twin complications
Region
| Japan |
Condition
Condition
Monochorionic twins
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Monochorionic (MC) twins are at risk for complications such as twin-to-twin transfusion syndrome (TTTS), selective fetal growth restriction (sFGR), and fetal heart failure, which have a significantly poor prognosis for life and neurological outcome. In some cases, these complications can cause circulatory failure, resulting in a significantly poor life and neurological prognosis. In this study, we aim to clarify the relationship between changes in fetal circulation and the pathogenesis and pathophysiology of these complications, keeping in mind the results of studies on ultrasound parameters and biomarkers in amniotic fluid/blood. This study aims to elucidate the pathophysiology and pathogenesis of poor prognosis complications in MC twins and to improve the perinatal prognosis of MC twins.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ultrasonographic parameters, biomarkers, perinatal outcomes
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
Monochorionic twins, Dichorionic twins, Normal fetuses underwent amniotic sentesis, fetal growth restriction
Key exclusion criteria
pregnant women under 18 years old
Target sample size
225
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Takano |
Organization
Toho University Faculty of Medicine
Toho University Omori Medical Center
Division name
Obstetrics and Gynecology
Zip code
143-8541
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
mayumi.takano@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Takano |
Organization
Toho University Omori Medical Center
Division name
Obstetrics and Gynecology
Zip code
143-8541
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
Homepage URL
mayumi.takano@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Obstetrics and Gynecology, Toho University Faculty of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Ethics Committee of Toho University Omori Medical Center
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo, Japan
Tel
03-3762-4151
mayumi.takano@med.toho-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
| 2024 | Year | 07 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ultrasonographic parameters, blood and amniotic fluid biomarkers, and perinatal outcomes
Management information
Registered date
| 2024 | Year | 07 | Month | 03 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062697
