Q89.9 O03
Conditions
Interventions
Group 1: Via questionnaire prospectively ascertained pregnancies with systemic NSAID/metamizole exposure during first trimester [1) NSAIDs, 2) selective cox inhibitors (coxibes), 3) acetylsalicylic ac
maternal malignancies. Data from our institute's patient registry.
Group 2: Control group: Via questionnaire prospectively ascertained pregnancies not exposed to a study medication [1) NSAIDs, 2) sele
Exclusion criteria: maternal malignancies. Data from our institute's patient registry.
Sponsors
Pharmakovigilanzzentrum Embryonaltoxikologie
Charité-Universitätsmedizin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Prospectively ascertained pregnancies, i.e. neither the outcome of pregnancy nor results of prenatal diagnostics are primarily known, but are ascertained at a later stage
Exclusion criteria
Exclusion criteria: Exclusion of cases with maternal malignancies or maternal exposure considered as potent teratogens or fetotoxicants: i.e. acenocoumarol, ACE-inhibitors and ARBs (AT1-Antagonists), carbamazepine, lenalidomide, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, retinoids (acitretin, adapalen, isotretinoin, tazaroten, tretinoin), thalidomide, topimarat, valproic acid, warfarin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Is there an increased rate of major birth defects after systemic exposure to the study medication [1) NSAIDs, 2) selective cox inhibitors (coxibes), 3) acetylsalicylic acid (ASA) in analgesic doses (defined as > 300mg/d), 4) metamizole] during 1. trimester of pregnancy? Is there an increased rate of spontaneous abortion after systemic exposure to the study medication 1)-4) during 1. trimester of pregnancy? The Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy counsels patients or their physicians about the risk of medication during pregnancy. This counselling mainly takes place in early pregnancy when outcome or prenatal diagnostic is not known. If the pregnant patient agrees, data are recorded by a structured questionnaire. Eight weeks after the estimated date of birth a further questionnaire is send to collect data about the pregnancy outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Is the risk for preterm delivery or low birthweight increased after systemic exposure to study medication 1)-4) during 1. trimester of pregnancy? Is there evidence of an exposure time-dependence spontaneous abortion rate during the 1st trimester? | — |
Countries
Germany
Contacts
Public ContactKatarina Dathe
Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
Outcome results
None listed