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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042436
Receipt No. 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 2020/11/13

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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 Obsterics 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
Email 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
Email ozawa-kt@ncchd.go.jp

Sponsor
Institute Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development
Institute
Department

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
Email 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
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 06 Month 30 Day
Date trial data considered complete
2023 Year 09 Month 30 Day
Date analysis concluded
2024 Year 03 Month 30 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
2020 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048426

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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