Table 1.
Summary of study design including Medicaid eligibility requirements for mothers and offspring, duloxetine exposure windows, outcome assessment windows, and covariate assessment windows
| Cohort and outcome | Medicaid eligibility requirement: mother | Medicaid eligibility requirement: offspring | Duloxetine exposure window | Outcome assessment window | Covariate assessment window |
|---|---|---|---|---|---|
| Cohort 1: | |||||
| Congenital malformations | 90 days before LMP to 30 days after delivery | 3 months after delivery (unless died) | Dispensed in first trimester | Delivery to 3 months after delivery | 90 days before LMP to end of first trimester |
| Early exposure | |||||
| Cohort 2: | |||||
| Preterm birth | 90 days before LMP to 30 days after delivery | 1 month after delivery (unless died) | Dispensed LMP to LMP+140 | Delivery to 1 month after delivery | 90 days before LMP to LMP+140 |
| Small for gestational age infant | 90 days before LMP to 30 days after delivery | 1 month after delivery (unless died) | Dispensed LMP to LMP+140 | Delivery to 1 month after delivery | 90 days before LMP to LMP+140 |
| Cohort 3: | |||||
| Pre-eclampsia | 90 days before LMP to 30 days after delivery | None | Dispensed LMP to LMP+140 | Delivery admission | 90 days before LMP to LMP+140 |
| Late exposure | |||||
| Cohort 2: | |||||
| Preterm birth | 90 days before LMP to 30 days after delivery | 1 month after delivery (unless died) | Dispensed LMP+141 to LMP+245 | Delivery to 1 month after delivery | 90 days before LMP to LMP+245 |
| Small for gestational age infant | 90 days before LMP to 30 days after delivery | 1 month after delivery (unless died) | Dispensed LMP+141 to LMP+245 | Delivery to 1 month after delivery | 90 days before LMP to LMP+245 |
| Cohort 3: | |||||
| Pre-eclampsia | 90 days before LMP to 30 days after delivery | None | Dispensed LMP+141 to LMP+245 | Delivery admission | 90 days before LMP to LMP+245 |
| Cohort 4: | |||||
| Postpartum hemorrhage | 4 months before delivery to 1 month after delivery | None | Dispensed 1 month before delivery to delivery | Delivery admission | 4 months before delivery to 1 day before delivery |
LMP=last menstrual period.