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Study on the safety of thiopurine preparations during pregnancy

Study on the safety of thiopurine preparations during pregnancy - preMENDEL2

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000045148
Enrollment
400
Registered
2021-10-03
Start date
2021-10-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All diseases for which thiopurine preparations are used

Interventions

None listed

Sponsors

Tohoku University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Frequency of NUDT15 genotype in infants for each NUDT15 genotype pair of parents

Secondary

MeasureTime frame
Frequency of pregnancy complications, frequency of genetic mutations in children, and analysis of transmission disequilibrium in pregnancies taking thiopurine

Countries

Japan

Contacts

Public ContactYoichi Kakuta

Tohoku University Hospital Division of Gastroenterology

ykakuta@med.tohoku.ac.jp0227177171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026