Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Non-interventional study

Non-interventional study design

Cohort
Case-control
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N06A) ANTIDEPRESSANTS
ANTIDEPRESSANTS
(N03) ANTIEPILEPTICS
ANTIEPILEPTICS
(A10) DRUGS USED IN DIABETES
DRUGS USED IN DIABETES
(R03) DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
(D10AD04) isotretinoin
isotretinoin

Medical condition to be studied

Congenital cardiovascular anomaly
Neural tube defect
Cleft lip and palate
Cleft palate
Hypospadias
Hydrocephalus
Microcephaly
Gastroschisis
Renal aplasia
Trisomy 21
Population studied

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)

Special population of interest

Pregnant women

Estimated number of subjects

120000
Study design details

Main study objective

The central aim is to build a European system for reproductive safety evaluation, which enables us to identify systematically and comprehensively the possible adverse effects in pregnancy of a drug in humans at the earliest stage post marketing, and enables us to monitor and evaluate safety measures undertaken in Europe.

Outcomes

An efficient system for methodical safety evaluation of drugs during pregnancy, based on an existing network of congenital anomalies registers in Europe and healthcare databases.A quantified risk of congenital anomaly related to new antiepileptics, insulin analogues, anti-asthmatics and SSRIs. A framework to evaluate the efficacy of pregnancy-related drug safety measures.

Data analysis plan

Workpackages 4,5: For three classes of medication (antiepileptics, antidepressants, antiashtmatics) we will analyse the specificity of association between specific medications and specific malformation types, using odds ratios, from a case-malformed control design.Workpackage 4: For insulin analogs, we will use a cohort design and relative risk of malformation.For Workpackage 6, a drug utilisation study, we will use prevalence of medication use during pregnancy.For Workpackage 7 concerning internet use by pregnant women, qualitative and survey methods.
Documents
Study, other information
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