congenital malformation and miscarriage after intrauterine triptane exposure Q89.9 O03
Conditions
Interventions
Group 1: study group: prospective assessment of gestation development in women with migraine disorder and systemic triptan exposure during pregnancy on the basis of structured questionnaires. Utilizat
Sponsors
Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: all cohorts: prospective assessment of gestation (outcome and results of prenatal diagnostics are still unknown and the data can be assessed prospectively) study group: exposure to triptans for migraine, exposure interval at least one day between first day of the last menstrual period and delivery (therapy may have started earlier and can have lasted longer) disease comparison group: maternal migraine not exposed to triptans between last menstrual period and delivery control group: pregnancies without maternal migraine and without any triptans medication during pregnancy (over a period from last menstrual period to delivery); matched with study group by year of ascertainment
Exclusion criteria
Exclusion criteria: all cohorts: retrospectively ascertained pregnancies control group: migraine disorder, acute malignancies, maternal exposure considered as teratogenic or fetotoxic: acenocoumarol, lenalidomide, carbamazepine, methotrexate, mycophenolate, phenobarbital, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide, topiramate, valproic acid, warfarin, angiotensin-converting enzyme (ACE)-inhibitors and angiotensin II receptor antagonists
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the risk of major birth defects and miscarriages in the context of maternal triptane exposure during pregnancy in comparison to the control and disease comparison group. | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate the risk of preterm delivery, low birth weight, postnatal complications (e.g. atonic uterus, postpartum hemorrhage), severe maternal drug-specific side effects or pregnancy complications (e.g. preeclampsia) and rate of electively terminated pregnancies in the context of maternal triptane exposure during pregnancy in comparison to the control and disease comparison group. | — |
Countries
Germany
Contacts
Public ContactKevin Spielmann
Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
Outcome results
None listed