congenital malformation/spontaneous abortion after intrauterine fluoroquinolone exposure MedDRA - 10010445 Congenital disorders NEC (HLT, 16.0) MedDRA - 10000235 abortions spontaneous (HLT, 16.0) O03 Q89.9
Conditions
Interventions
Group 1: Via questionnaire prospectively ascertained pregnancies with systemic fluoroquinolone exposure during first trimester. Data from our institute's patient registry.
Group 2: Control group: Via
Sponsors
Pharmakovigilanzzentrum Embryonaltoxikologie
Charité-Universitätsmedizin
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: For both cohorts: 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. Study group (Fluoroquinolone exposed pregnancies): Pregnant women, who had a systemic exposure to fluoroquinolones (oral or intravenous) between gestational week 2+0 and 12+6 after last menstrual period. Control group: Pregnant women, who were neither exposed to fluoroquinolones nor strong teratogenic or fetotoxic substances. The control group is matched with the study group for year of enrolment.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the control group are cancer or seizures except preklampsia. Furthermore, the exposure to one of the following substances is an exclusion criteria: Acitretin, carbamazepine, isotretinoin, methotrexate, mycophenolate, phenobarbital, phenprocoumon, phenytoin, valproic acid, warfarin, ACE inhibitors, angiotensin II receptor antagonist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Is there an increased rate of major birth defects or rate of spontaneous abortion after systemic exposure to fluoroquinolones during the first trimester of pregnancy? | — |
Secondary
| Measure | Time frame |
|---|---|
| Is the risk for preterm delivery or low birthweight increased after systemic exposure to fluoroquinolones during the first trimester of pregnancy? Is there a “teratogenic time window” for fluoroquinolones during the first trimester of pregnancy? | — |
Countries
Germany
Contacts
Public ContactStephanie Padberg
Pharmakovigilanzzentrum Embryonaltoxikologie Charité-Universitätsmedizin
Outcome results
None listed