Course and outcome of pregnancies in patients with Restless Legs Syndrome (RLS) - an evaluation of the German Embryotox database
- Conditions
- G25.81
- Registration Number
- DRKS00033610
- Lead Sponsor
- Charité-Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 900
Inclusion Criteria
Enrollment of pregnancies, of which neither the outcome nor pathological results of prenatal diagnostics are known at the first contact.
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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