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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

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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
Email 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
Email 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
Email 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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2022 Year 06 Month 30 Day
Last follow-up date
2022 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
2022 Year 05 Month 15 Day


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


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