Inflammatory bowel diseases Crohn's disease Ulcerative colitis Pregnancy Offspring Thioguanine Congenital abnormalities Mutagenic Teratogenic
Conditions
Interventions
None
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: Female patients with inflammatory bowel disease exposed to thioguanine during (a period of) the pregnancy.
Exclusion criteria
Exclusion criteria: Patients with concomitant use of possible teratogenic drugs such as ACE inhibitors, angiotensin II antagonist, isotretinoin, cocaine, high doses of vitamin A, androgens, tetracycline, doxycycline, streptomycin, phenytoin, valproic acid, trimethadione, paramethadione, carbamazepine, lithium, methotrexate, penicillamine, thiouracil, carbimazole, thalidomide, warfarin, diethylstilbestrol, cocaine and alcohol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to assess the safety of thioguaninein maternally exposed offspring. Efficacy variables will be the number and aspect of birth defects (minor and major) and rate of pre-term births, low-birth weights, (spontaneous) abortions and neonatal morbidity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy variables will be the number of complications during pregnancy and delivery, and the course after delivery. Furthermore, signs of myelosuppression or hepatotoxicity in the neonate and thiopurine metabolite measurements in the neonate (if applicable) will be assessed. | — |
Contacts
Public ContactM. Simsek
Department of Gastroenterology and Hepatology, VU University Medical Centre Amsterdam
Outcome results
None listed