UMIN-CTR Clinical Trial

Basic information
Public title	Study on the safety of thiopurine preparations during pregnancy
Acronym	preMENDEL2
Scientific Title	Study on the safety of thiopurine preparations during pregnancy
Scientific Title:Acronym	preMENDEL2
Region	Japan

Condition
Condition	All diseases for which thiopurine preparations are used
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Nephrology Neurology Clinical immunology Surgery in general Obsterics and gynecology Pediatrics Adult Child
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this study is to clarify whether there is any association between pregnancy and childbirth complications, including miscarriage and stillbirth, and child development and birth complications in patients taking thiopurine preparations, especially whether the NUDT15 gene polymorphism of the patient, male partner, and fetus is associated with these complications.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of NUDT15 genotype in infants for each NUDT15 genotype pair of parents
Key secondary outcomes	Frequency of pregnancy complications, frequency of genetic mutations in children, and analysis of transmission disequilibrium in pregnancies taking thiopurine

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients: Women over 20 years old. Any underlying disease is acceptable. Then, patients who satisfy any one of A or B. A) Female patients who became pregnant while taking a thiopurine preparation (thiopurine can be discontinued after pregnancy) B) Patients who have been treated with a thiopurine preparation for more than 60 days during pregnancy Male partner (participation required*): Male patients aged 20 years or older. Male partner with pregnancy corresponding to either A or B above Child (participation required* for children who are pregnant while taking thiopurine): Any age or sex All children of patient/partner pairs participating in this study Children who became pregnant or gave birth during the period when they were not taking thiopurine products can also participate voluntarily. However, if the child is born in a pregnancy during which the patient was taking thiopurine, the child's participation is *required* in principle.
Key exclusion criteria	Cases in which the medication status at the time of pregnancy cannot be determined. Cases in which all the specimens of the partner (required) and the child (required for children born in pregnancies while taking thiopurine, optional for other pregnancies) are not available.
Target sample size	400

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	9808574
Address	1-1 Seiryo Aoba, Sendai
TEL	0227177171
Email	ykakuta@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Yoichi Middle name Last name Kakuta
Organization	Tohoku University Hospital
Division name	Division of Gastroenterology
Zip code	980-8574
Address	1-1 Seiryo Aoba, Sendai
TEL	0227177171
Homepage URL	https://premendel.ibd.ai/
Email	ykakuta@med.tohoku.ac.jp

Sponsor
Institute	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	Tohoku University Graduate School of Medicine Ethics Committee
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
Tel	022-717-3867
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	2021 Year 10 Month 03 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	Enrolling by invitation
Date of protocol fixation	2021 Year 09 Month 28 Day
Date of IRB	2021 Year 09 Month 29 Day
Anticipated trial start date	2021 Year 10 Month 04 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2025 Year 03 Month 31 Day

Other
Other related information	None

Management information
Registered date	2021 Year 08 Month 13 Day
Last modified on	2022 Year 08 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051516