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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000047759 |
Receipt No. | R000054449 |
Scientific Title | PROFIT |
Date of disclosure of the study information | 2022/05/16 |
Last modified on | 2022/05/15 |
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 |
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Condition | ||
Condition | Inflammatory Bowel Disease
Ulcerative colitis Crohn's disease |
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Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 |
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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 | |
Institute | Division of Gastroenterology, Tohoku University Hospital |
Institute | |
Department |
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 |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | 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 | |
Registered date | File name |
Research case data | |
Registered date | File name |