Table 1 Key definitions for enrolment characteristics
Variable | Definition |
|---|---|
gestational hypertension | de novo systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg after 20 weeks' gestation, without proteinuria |
severe hypertension | systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 110 mmHg |
proteinuria | ≥ 1+ on dipstick, or ≥ 300 mg/24 hours, or spot urine protein/creatinine ratio ≥ 30 mg/mmol |
pre-eclampsia (for women normotensive at trial entry) | de novo systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg after 20 weeks' gestation with new-onset proteinuria as described above |
pre-eclampsia (for women with chronic hypertension at trial entry) | new-onset proteinuria as described above |
pre-eclampsia (for women with chronic hypertension and proteinuria at trial entry) | signs and symptoms of superimposed pre-eclampsia after 20 weeks' gestation, for example worsening of hypertension or proteinuria |
early onset proteinuria | proteinuria as defined above, occurring ≤ 33 weeks + 6 days of gestation |
early onset pre-eclampsia | hypertension and early onset proteinuria as described above |
chronic hypertension | Essential hypertension: BP ≥ 140/90 mmHg pre-conception or in first half of pregnancy without an underlying cause, or Secondary hypertension: hypertension associated with renal, renovascular, cardiac and endocrine disorders |
intrauterine growth restriction (IUGR) or small for gestational age (SGA) | growth below the 3rd centile, or as defined in the individual trial |
miscarriage / fetal death | any death in utero |
perinatal death | death in utero or within the first 7 days of life |
neonatal death | live born and any reported death within the first 28 days |