Study type

Study type

Non-interventional study

Scope of the study

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

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N02CC) Selective serotonin (5HT1) agonists

Medical condition to be studied

Migraine
Vomiting
Gestational diabetes
Maternal hypertension affecting foetus
Premature baby
Low birth weight baby
Small for dates baby
Live birth
Congenital anomaly
Population studied

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)

Special population of interest

Pregnant women

Estimated number of subjects

5000000
Study design details

Main study objective

To study the association between prenatal exposure to triptans/migraine medications and adverse maternal and pregnancy outcomes. The potential impact of exposure misclassification on exposure-outcome associations will be assessed under a range of scenarios. Further, to describe drug utilization patterns in women with migraine, and identify event finding algorithms for migraine and maternal events.

Outcomes

Major congenital anomalies in offspring, maternal preeclampsia and gestational diabetes mellitus, - non-live birth (y/n) - preterm birth (y/n), GA (cont. in days) - low birth weight (y/n), BW (cont. in gram, z-scores) - small for gestational age/ intrauterine growth restriction

Data analysis plan

We will estimates prevalence of migraine medication use in the drug utilisation part. In the safety part of the study, risk ratios/hazard ratios/mean differences of the various outcomes by exposure status are estimated using regression models. We will account for confounding using methods within the causal inference framework (eg, marginal structural models). Absolute risk difference and population attributable fractions will also be computed.