Q89.9 O03 P95
Conditions
Interventions
Group 1: Pregnant patients with JAK inhibitor exposure during pregnancy.
Study cohort (exposed to JAK inhibitors): 44 pregnancies (in the first trimester: all exposed to JAK inhibitors, second/third t
Sponsors
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: JAK inhibitor exposure during pregnancy At the time of initial contact with the PVZ Embryonal Toxicology Center, the outcome of the pregnancy is unknown and there are no pathological findings at this time. Contact with the PVZ Embryonaltoxikologie for drug counseling during pregnancy during the specified study period 01/01/2017-11/15/2025. Information on the outcome of the pregnancy is available; the quality of the information/data must meet internal standards.
Exclusion criteria
Exclusion criteria: Malignant diseases Insufficient data on pregnancy outcome or implausible, missing relevant data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Congenital malformations, spontaneous abortions, stillbirths After initial contact by telephone in response to inquiries from patients or their physicians regarding therapy with JAK inhibitors during pregnancy, a follow-up using a structured questionnaire is arranged according to defined criteria. This is sent to the inquiring person two months after the calculated delivery date. It contains questions about the course of the pregnancy, birth, and subsequent examinations of the child (U1 and U3). If any abnormalities are found, contact is made again and, if necessary, further documents are requested. | — |
Secondary
| Measure | Time frame |
|---|---|
| Birth weight, head circumference, gestational age at delivery, other pregnancy complications, e.g., intrauterine growth restriction (IUGR) After initial contact by telephone in response to inquiries from patients or their physicians regarding therapy with JAK inhibitors during pregnancy, a follow-up using a structured questionnaire is arranged according to defined criteria. This is sent to the inquiring person two months after the calculated delivery date. It contains questions about the course of the pregnancy, birth, and subsequent examinations of the child (U1 and U3). If any abnormalities are found, contact is made again and further documents are requested if necessary. | — |
Countries
Germany
Contacts
Public ContactAnna-Sophia Habbel
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie
Outcome results
None listed