Study type

Study type

Non-interventional study

Scope of the study

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

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

MODAFINIL
ARMODAFINIL

Medical condition to be studied

Pregnancy
Exposure during pregnancy
Population studied

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Adults (18 to < 46 years)

Special population of interest

Pregnant women

Estimated number of subjects

1000
Study design details

Main study objective

to estimate the prevalence of pregnancy outcomes, including maternal and fetal outcomes, in women exposed to modafinil/armodafinil during pregnancy, compared to an unexposed cohort

Outcomes

major congenital malformation, spontaneous abortions, stillbirths, low birth weight and small for gestational age births/intrauterine growth retardation/failure to thrive, preterm delivery

Data analysis plan

Study data will be summarized using descriptive statistics. The prevalence of major congenital malformations will be calculated as the number of total major congenital malformations out of the total number of births. Analysis of the primary endpoint, major congenital malformations, and other secondary endpoints will be performed using proportions with 2 sided 95% CI, as applicable. Comparisons of pregnancy outcome rates will be made between modafinil/armodafinil exposed women and the comparison cohort. For the comparisons, the point estimates of relative risks with 95% CIs and nominal p values will be reported. If feasible, an adjusted relative risk ratio for major congenital malformations among modafinil/armodafinil exposed women compared to unexposed women will be estimated using a logistic regression model adjusting for other confounding factors such as maternal age, and year of pregnancy.