Table 1 Pregnancy outcomes and pregnancy-related events of interest

Pregnancy outcomes

Assessed from start of pregnancy to pregnancy end date

Live birth

Preterm delivery (or record of live birth occurring < 37 weeks GA)

Fetal death/stillbirth (loss at or after 22 weeks GA)

Miscarriage ^a

Termination (elective or therapeutic)

Miscarriage or termination (composite endpoint)

Ectopic pregnancy

Pregnancy-related events of interest

Assessed from start of pregnancy to 90 days post-pregnancy end date

Maternal sepsis

Vaginal or intrauterine hemorrhage

Pre-eclampsia

Eclampsia

Pregnancy-related hypertension

Liver or biliary disease

Assessed from start of pregnancy to pregnancy end date

Premature or preterm labor

Labor protraction or arrest disorders

Oligohydramnios

Polyhydramnios

Intrauterine growth restriction or poor fetal growth

Gestational diabetes mellitus

Assessed during period as stated

Maternal death (from start of pregnancy to 42 days after delivery date)

Preterm premature rupture of membranes (from start of pregnancy until 37 weeks GA)

Fetal/perinatal distress or asphyxia (from start of pregnancy to 7 days after delivery)