UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047759 |
|---|---|
| Receipt number | R000054449 |
| Scientific Title | PROFIT |
| Date of disclosure of the study information | 2022/05/16 |
| Last modified on | 2023/05/16 09:02:00 |
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Basic information
Public title
Questionnaire survey on pregnancy, delivery, and child prognosis in patients with inflammatory bowel disease
Acronym
PROFIT
Scientific Title
PROFIT
Scientific Title:Acronym
PROFIT
Region
| Japan |
Condition
Condition
Inflammatory Bowel Disease
Ulcerative colitis
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to build evidence that will be helpful for patients with inflammatory bowel disease to consider pregnancy and childbirth, based on past surveys.
Basic objectives2
Others
Basic objectives -Others
Attitude Survey
natural history survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preference to have a baby
Concerns about pregnancy, childbirth, and childcare
Changes in medical conditions during pregnancy and after delivery
Drugs used during pregnancy
Maternal complications during pregnancy
Maternal complications during pregnancy
Congenital diseases of the child
Development and diseases of the child after birth
Key secondary outcomes
Comparison of miscarriage rates by drug
Breastfeeding Rates
Method of delivery
Infertility treatment
Percentage of discontinuation of medications during pregnancy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Patients with a diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
(2) Adult female patients
(3) Age of onset less than 50 years old
(4) Any disease type and treatment history
Key exclusion criteria
Cases that the attending physician or principal investigator considers inappropriate
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Kakuta |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
980-8574
Address
Sendai
TEL
0227177171
ykakuta@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Sayumi |
| Middle name | |
| Last name | Takahashi |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
980-8574
Address
1-1 Seiryo Aoba, Sendai, Miyagi Japan
TEL
0227177171
Homepage URL
profit@gastroente.med.tohoku.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Ethics Committee, Graduate School of Medicine, Tohoku University
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2022 | Year | 05 | 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
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
| 2022 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The survey is a non-submitted questionnaire and will not be tracked.
Management information
Registered date
| 2022 | Year | 05 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054449
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
