Definition of preeclampsia and endpoints
Primary endpoint was occurrence of preeclampsia as defined by the
International Society for the Study of Hypertension in Pregnancy in 20183. In brief, the diagnosis of preeclampsia was
persistent de novo gestational hypertension that develops at or after 20
weeks’ gestation accompanied by one or more of the following new-onset
conditions: 1) proteinuria (>30 mg/dL); 2) other maternal
organ dysfunction, including: acute kidney injury, liver involvement,
neurological complications, hematological complications; 3)
uteroplacental dysfunction (such as fetal growth restriction, abnormal
umbilical artery Doppler wave form analysis, or stillbirth). Eclampsia
was defined by new-onset of tonic-clonic, focal or multifocal seizures
in the absence of other causative conditions such as epilepsy, cerebral
arterial ischemia and infarction, intracranial hemorrhage, or drug use.
Secondary endpoint was time to preeclampsia free survival, which was
defined by the number of months free of preeclampsia between the
20th and 37th week of amenorrhea.
Patients were censored after the 37th week of
amenorrhea.