UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042436 |
|---|---|
| Receipt number | R000048426 |
| Scientific Title | The study of pathophysiology and prediction of umbilical cord ulcer by a registry of fetuses with duodenal and jejunal atresia |
| Date of disclosure of the study information | 2020/11/13 |
| Last modified on | 2022/07/29 00:53:58 |
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Basic information
Public title
The study of pathophysiology and prediction of umbilical cord ulcer by a registry of fetuses with duodenal and jejunal atresia
Acronym
The study of pathophysiology and prediction of umbilical cord ulcer by a registry of fetuses with duodenal and jejunal atresia
Scientific Title
The study of pathophysiology and prediction of umbilical cord ulcer by a registry of fetuses with duodenal and jejunal atresia
Scientific Title:Acronym
The study of pathophysiology and prediction of umbilical cord ulcer by a registry of fetuses with duodenal and jejunal atresia
Region
| Japan |
Condition
Condition
Fetal duodenal and Jejunal atresia
Classification by specialty
| Gastrointestinal surgery | Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find factors relating to perinatal outcome of the fetus with duodenal and Jejunal atresia
Basic objectives2
Others
Basic objectives -Others
To clarify pathophysiology of umbilical cord ulcer occurring to the fetus with duodenal and Jejunal atresia
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of umbilical cord ulcer of more than grade 2
Key secondary outcomes
1 The incidence of umbilical cord ulcer of more than grade 2
2 The incidence of premature delivery
3 The incidence of fetal and neonatal death
4 The incidence of fetal distress
5 The incidence of neonatal asphyxia
6 The incidence of neonatal acidosis
7 The incidence of neonatal anemia
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
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
1 The fetuses with duodenal and Jejunal atresia
2 The cases that we obtain the consent of the research from
Key exclusion criteria
Fetuses
1 The duodenal and Jejunal atresia in both of DCDA twins
2 MC twins or multiple pregnancies that have more than three fetuses
Pregnant women
1 Less than 20 years old
2 The women who principal investigators (PIs) judge to be inappropriate for the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsusuke |
| Middle name | |
| Last name | Ozawa |
Organization
National Center for Child Health and Development
Division name
Division of Fetal Medicine
Zip code
157-8535
Address
2-10-1 Okura Setagaya, Tokyo 157-8535, Japan
TEL
0334160181
ozawa-kt@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Katsusuke |
| Middle name | |
| Last name | Ozawa |
Organization
National Center for Child Health and Development
Division name
Division of Fetal Medicine
Zip code
157-8535
Address
2-10-1 Okura Setagaya, Tokyo 157-8535, Japan
TEL
0334160181
Homepage URL
ozawa-kt@ncchd.go.jp
Sponsor or person
Institute
Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee in National Center for Child Health and Development
Address
2-10-1 Okura Setagaya, Tokyo 157-8535, Japan
Tel
0334160181
rinri@ncchd.go.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
国立成育医療研究センター（東京都）
日本赤十字社医療センター（東京都）
東京都立多摩総合医療センター（東京都）
東京都立小児総合医療センター（東京都）
さいたま赤十字病院（埼玉県）
埼玉県立小児医療センター（埼玉県）
東京大学医学部附属病院（東京都）
順天堂医院（東京都）
神奈川県立こども医療センター（神奈川県）
静岡県立こども病院（静岡県）
聖隷浜松病院（静岡県）
岐阜県総合医療センター（岐阜県）
名古屋大学医学部附属病院（愛知県）
大阪大学医学部附属病院（大阪府）
大阪母子医療センター（大阪府）
山口大学病院（山口県）
九州大学病院（福岡県）
福岡市立こども病院（福岡県）
久留米大学病院（福岡県）
胆汁酸研究所（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
The data that we collect are below.
1. Background of pregnancies
2. Fetal findings and course of pregnancy
3. Biochemical data of amniotic fluid
4. Course of Delivery
5. Neonatal findings and course
6. Surgical (autopsy) findings
7. Pathology of umbilical cord and placenta
Management information
Registered date
| 2020 | Year | 11 | Month | 13 | Day |
Last modified on
| 2022 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048426
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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