UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037702
Receipt number R000042999
Scientific Title Study of the pathophysiology of fetal circulatory changes in monochorionic twin pregnancies.
Date of disclosure of the study information 2019/08/16
Last modified on 2022/08/18 10:34:19

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Basic information

Public title

Study of the pathophysiology of fetal circulatory changes in monochorionic twin pregnancies.

Acronym

Study of fetal circulatory changes in monochorionic twin pregnancies.

Scientific Title

Study of the pathophysiology of fetal circulatory changes in monochorionic twin pregnancies.

Scientific Title:Acronym

Study of fetal circulatory changes in monochorionic twin pregnancies.

Region

Japan


Condition

Condition

twin-to-twin transfusion syndrome

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the mechanism of fetal circulatory failure in compromised monochorionic twin pregnancies.

Basic objectives2

Others

Basic objectives -Others

Exploratory research

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Biomarker in amniotic fluid and umbilical cord blood. Vascular substances in placental tissue. Neonatal condition.
Relations between these parameters and ultrasound indices.

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

20 years-old <=

Age-upper limit

50 years-old >=

Gender

Female

Key inclusion criteria

monochorionic twin pregnancies

Key exclusion criteria

Someone in socially vulnerable position

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masahiko
Middle name
Last name Nakata

Organization

Toho University Omori Medical Center

Division name

Department of Obstetrics and Gynecology

Zip code

1438541

Address

6-11-1 Omorinishi, Ota-ku, Tokyo

TEL

03-3762-4151

Email

masahiko.nakata@med.toho-u.ac.jp


Public contact

Name of contact person

1st name Masahiko
Middle name
Last name Nakata

Organization

Toho University Omori Medical Center

Division name

Department of Obstetrics and Gynecology

Zip code

1438541

Address

6-11-1 Omorinishi, Ota-ku, Tokyo

TEL

03-3762-4151

Homepage URL


Email

masahiko.nakata@med.toho-u.ac.jp


Sponsor or person

Institute

Toho University Omori Medical Center

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Toho University Omori Medical Center

Address

6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541

Tel

03-3762-4151

Email

omori.rinri@ext.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

2019 Year 08 Month 16 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

60

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

Main results already published

Date of protocol fixation

2019 Year 08 Month 16 Day

Date of IRB

2019 Year 08 Month 09 Day

Anticipated trial start date

2019 Year 08 Month 16 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 06 Month 30 Day

Date trial data considered complete

2022 Year 07 Month 31 Day

Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information

none


Management information

Registered date

2019 Year 08 Month 16 Day

Last modified on

2022 Year 08 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042999


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name