Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Exposure during pregnancy
Population studied

Short description of the study population

Publicly insured pregnant women 18 to 55 years of age.

Inclusion criteria:
i. Base cohort to include pregnancies drawn from the MAX database with linked offspring from 2004 to 2013
ii. Maternal eligibility for Medicaid from 3 months prior to the LMP until 1 month post delivery
iii. Offspring eligibility from months 1 to 3 after the delivery, unless the infant died prior to the end of the 3 months, in which case a shorter eligibility period until death were permitted

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)

Special population of interest

Pregnant women

Estimated number of subjects

1400
Study design details

Main study objective

To assess the safety of duloxetine for the developing fetus. Specifically:• To assess the safety of duloxetine for the developing fetus. • To assess the safety of duloxetine for the pregnant woman.

Outcomes

Major congenital malformations, Postpartum haemorrhage, Preeclampsia, Small for gestational age, Preterm delivery, and non-live birth.

Data analysis plan

Results will be presented for four levels of adjustment: (i) unadjusted, (ii) restricted to women with recorded depression, anxiety, specific pain conditions to control for the potential effect of the underlying illness or factors associated with it, using PS stratification to account for imbalances in the specific indication, (iii) restricted to women with a recorded diagnosis of the indications, using PS stratification to further control for imbalances in the specific indication, proxies of severity of the underlying indication and other potential confounders128, and (iv) restricted to women with a recorded diagnosis of the indications, using high-dimensional propensity score (hdPS) stratification to further reduce residual confounding by controlling for proxies of unmeasured confounders.