UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018134 |
|---|---|
| Receipt number | R000020939 |
| Scientific Title | Reproduction and Pregnancy in Inflammatory Bowel Disease |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2025/01/09 00:17:11 |
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Basic information
Public title
Reproduction and Pregnancy in Inflammatory Bowel Disease
Acronym
Reproduction and Pregnancy in Inflammatory Bowel Disease
Scientific Title
Reproduction and Pregnancy in Inflammatory Bowel Disease
Scientific Title:Acronym
Reproduction and Pregnancy in Inflammatory Bowel Disease
Region
| Japan |
Condition
Condition
Inflammatory Bowel Disease(Crohn's Disease and Ulcerative Colitis)
Classification by specialty
| Gastroenterology | Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reproduction and pregnancy in IBD- a prospective observational study
Basic objectives2
Others
Basic objectives -Others
Dose adherence to medical treatment during pregnancy affect the disease activity or outcome? - an observational study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
disease activity during the pregnancy, outcome of pregnancy
Key secondary outcomes
adherence to medication
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
| Not applicable |
Gender
Female
Key inclusion criteria
pregnant woman with IBD
Key exclusion criteria
The exclusion renders people unwilling, but not unable, or people with incomplete diagnosis of IBD.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hokari Ryota |
Organization
National Defense Medical College
Division name
Department of Internal Medicine
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama 359-8513, Japan
TEL
0429951511
chikakow@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Watanabe Chikako |
Organization
National Defense Medical College
Division name
Department of Internal Medicine
Zip code
Address
3-2 Namiki, Tokorozawa, Saitama 359-8513, Japan
TEL
0429951511
Homepage URL
chikakow@ndmc.ac.jp
Sponsor or person
Institute
Health and Labour Sciences Research Grants for research on intractable diseases from Ministry of Health, Labour and Welfare of Japan
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grants for research on intractable diseases from Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 07 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Anonymous Questionnaire / Observational Study
Management information
Registered date
| 2015 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020939
