Table 2 Summary of primary and secondary outcome definitions and analytic populations
Primary outcomes | Definition |
|---|---|
Preeclampsia | Gestational hypertension and gestational proteinuria among participants without chronic hypertension; or, gestational proteinuria among participants with chronic hypertension (superimposed preeclampsia); or, clinical diagnosis of preeclampsia by managing clinical team; or, development of severe features of preeclampsia with or without proteinuria |
Preterm birth | Live birth < 37 weeks completed weeks gestation |
Secondary outcomes | Definition |
Gestational hypertension | A systolic blood pressure ≥ 140 mm Hg on two occasions at least 1 h apart; or, diastolic blood pressure ≥ 90 mm Hg on two occasions at least 1 h apart; or, severe gestational hypertension in pregnancy among participants without chronic hypertension, defined in the antenatal period as systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 110 mmHg on two occasions at least 1 min apart after 20 weeks gestation and defined at the time of labor/delivery as requiring only one systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 110 mmHg. Note: Chronic hypertension defined by a clinical diagnosis of chronic hypertension (with or without need for medication) or systolic blood pressure ≥ 140 mm Hg on two occasions at least 1 h apart or diastolic blood pressure ≥ 90 mm Hg on two occasions at least 1 h apart before 20 weeks’ gestation. |
Severe features of preeclampsia | The following will be defined as severe features of preeclampsia: • Severe gestational hypertension (with or without proteinuria), or • Eclampsia, or • Evidence of end organ dysfunction by laboratory criteria, or • Clinical diagnosis of HELLP syndrome (hemolysis, elevated liver function, low platelets), or • Development of pulmonary edema, or • New onset CNS or visual symptoms |
Pregnancy-related death within 42 days of termination of pregnancy | Death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the cause of death |
Third trimester severe anemia (targeted safety outcome) | Hemoglobin concentration < 7.0 g/dL [19] |
Fetal death | A product of human conception, irrespective of the duration of the pregnancy, which, after expulsion or extraction, does not breath or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached [20] |
Stillbirth | Fetal death ≥ 28 weeks gestation |
Low birthweight | Live birth weighing < 2500 g |
Small-for-gestational age birth | Live birth with size-for-gestational age < 10th percentile on the INTERGROWTH-21st standard |
Infant death < 42 days | Death of a live birth during the first 42 completed days of life (6 weeks postpartum) |