UMIN-CTR Clinical Trial

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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