G25.81
Conditions
Interventions
Group 1: Observational study: Evaluation of pregnancy course and outcome based on data from the Embryotox-cohort (Study period: 01.01.2000 bis 31.12.2023).
Studykohort: about 280 pregnancies of women
Sponsors
Charité-Universitätsmedizin Berlin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Enrollment of pregnancies, of which neither the outcome nor pathological results of prenatal diagnostics are known at the first contact.
Exclusion criteria
Exclusion criteria: Therapy of maternal malignancies during pregnancy and cases with maternal exposure considered as potent teratogens or fetotoxicants: i.e. valproate, topiramate and carbamazepine as well as acenocoumarol, ACE-inhibitors and AT1-antagonists (exposure in 2nd and 3rd trimester), lenalidomide, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide and warfarin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Risk quantification, e.g. major birth defects or spontaneous abortion, as well as premature birth, intrauterine growth restriction or pregnancy complications like gestational diabetes, gestational hypertension or preeclampsia. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of maternal characteristics and treatment pattern in pregnancies of women with RLS. Is there an increased risk for major birth defects or spontaneous abortion after first trimester exposure to L-dopa/benserazide or pramipexol | — |
Countries
Germany
Contacts
Public ContactMaria Hoeltzenbein
Charité-Universitätsmedizin Berlin
Outcome results
None listed