Are fluoroquinolones teratogenic in humans? Evaluation of the Embryotox patient-database

• Conditions: congenital malformation/spontaneous abortion after intrauterine fluoroquinolone exposureMedDRA - 10010445 Congenital disorders NEC (HLT, 16.0)MedDRA - 10000235 abortions spontaneous (HLT, 16.0); O03; Q89.9; Spontaneous abortion; Congenital malformation, unspecified

• Registration Number: DRKS00004864
• Lead Sponsor: Pharmakovigilanzzentrum EmbryonaltoxikologieCharité-Universitätsmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-05
• Study Completion: 2013-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 4745

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 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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Is the risk for preterm delivery or low birthweight increased after systemic exposure to fluoroquinolones during the first trimester of pregnancy?<br>Is there a teratogenic time window” for fluoroquinolones during the first trimester of pregnancy?