UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052405 |
|---|---|
| Receipt number | R000059813 |
| Scientific Title | Analysis of pregnancy, birth and baby in patients with inflammatory bowel diseases on a nationwide registry in Japan |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/10/04 15:22:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analysis of pregnancy, birth and baby in patients with inflammatory bowel diseases on a nationwide registry in Japan
Acronym
Analysis of pregnancy, birth and baby in patients with inflammatory bowel diseases on a nationwide registry in Japan
Scientific Title
Analysis of pregnancy, birth and baby in patients with inflammatory bowel diseases on a nationwide registry in Japan
Scientific Title:Acronym
Analysis of pregnancy, birth and baby in patients with inflammatory bowel diseases on a nationwide registry in Japan
Region
| Japan |
Condition
Condition
IBD
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Obstetrics and Gynecology |
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a registry in Japan of patients with IBD who were pregnant .
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To confirm the safety of drugs used for IBD treatment in the maternal period against the birth outcome.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
pregnant IBD patients above 16yrs old
Key exclusion criteria
Inappropriate patients for research who were judged by the researcher
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Hokari |
Organization
National Defense Medical College
Division name
department of internal medicine
Zip code
359-8513
Address
3-2 Namiki Tokorozawa
TEL
0429951609
ryota@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Hokari |
Organization
National Defense Medical College
Division name
department of internal medicine
Zip code
3598513
Address
3-2 namiki tokorozawa
TEL
0429951511
Homepage URL
ryota@ndmc.ac.jp
Sponsor or person
Institute
National defense medical college
Institute
Department
Personal name
Ryota Hokari
Funding Source
Organization
Ministry of welfare
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
Kyoto University
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
RADDAR-J 81
Org. issuing International ID_1
Kyoto Univ.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 01 | 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
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2034 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2034 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2034 | Year | 12 | Month | 31 | Day |
Other
Other related information
ND
Management information
Registered date
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059813
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
