Observational Studies to Assess Maternal and Fetal Outcomes Following Exposure to Duloxetine (F1J-MC-B057)

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:
  • Paediatric Population (< 18 years)

    • Neonate

      • 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.