UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045148 |
|---|---|
| Receipt number | R000051516 |
| Scientific Title | Study on the safety of thiopurine preparations during pregnancy |
| Date of disclosure of the study information | 2021/10/03 |
| Last modified on | 2022/08/13 12:45:44 |
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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 | Obstetrics 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
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/
ykakuta@med.tohoku.ac.jp
Sponsor or person
Institute
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
Tohoku University Graduate School of Medicine Ethics Committee
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-3867
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051516
