Table 4.
Cohort selection
Definition | Number of pregnancies | |||
---|---|---|---|---|
Cohort 1: malformations | Cohort 2: preterm birth/small for gestational age infant | Cohort 3: pre-eclampsia | Cohort 4: postpartum hemorrhage | |
Pregnancies 2004-13 | 9 079 307 | |||
Restrict to age ≥18 years | 8 410 882 | |||
Implement maternal eligibility criteria* | 1 452 823 | 1 452 823 | 1 452 823 | 4 135 740 |
Implement infant eligibility criteria | 1 294 742 | 1 369 189 | - | - |
Exclude pregnancies with chromosomal abnormality | 1 292 075 | - | - | - |
Exclude pregnancies with exposure to definite teratogen | 1 289 296 | - | - | - |
Exclude pregnancies with duloxetine exposure before but not during etiologically relevant window | 1 287 359 | 1 367 199 | 1 450 755 | 4 135 000 |
Exposed to duloxetine | 2532 (trimester 1) | 2903 (early); 880 (late) | 3059 (early); 933 (late) | 955 (month before delivery) |
Continuous Medicaid eligibility (without gaps) from start of covariate assessment window through end of outcome assessment window; no private insurance or restricted benefits; appropriate enrollment type depending on state.