This is a phase-III multi-center open-label randomized clinical trial of 4,120 individuals between 23 weeks, 0 days and 35 weeks, 6 days gestation with gestational hypertension or preeclampsia without severe features randomized to antihypertensive medication to a target blood pressure (BP) of <140/90 mmHg or to no treatment for non-severe hypertension < 160/110 mmHg (usual care). The primary endpoint is an adverse pregnancy composite comprised of preeclampsia with end-organ damage, medically indicated preterm delivery <37 weeks 0 days gestation, fetal/neonatal/infant death, or placental abruption.
INCLUSION CRITERIA:
Singleton or di-chorionic twin gestation.
Gestational age at randomization from 23 weeks 0 days through 35 weeks 6 days based on clinical information and evaluation of the earliest ultrasound
Diagnosis of gestational hypertension or preeclampsia without severe features within 10 days prior to randomization.
EXCLUSION CRITERIA:
Known allergy or hypersensitivity to both labetalol and nifedipine ER
Two blood pressure measurements ≥ 140/90 at least 4 hours apart prior to 20 weeks 0 days in the current pregnancy
History or current use of anti-HTN medication defined as any of the following:
High-risk co-morbidities for which treatment at a lower blood pressure level (i.e., below the standard cutoff of 160/110) may be indicated
Preeclampsia with severe features defined as any of the following:
Severe hypertension defined as new onset systolic blood pressure ≥ 160 or diastolic blood pressure ≥ 110 on two occasions at least 4 hours apart (unless antihypertensive medication is initiated before this time) on or after 20 weeks 0 days gestation.
Severe features of preeclampsia as evidenced by end organ damage defined as any of the following on or after 20 weeks 0 days gestation:
Eclampsia
rclifton@bsc.gwu.edu
Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy