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.
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.
Gestational hypertension or preeclampsia is defined as new onset systolic blood pressure 140-159 or diastolic blood pressure 90-109 (or both) on two occasions at least four hours apart on or after 20 weeks 0 days gestation with normal end-organ labs, with or without proteinuria.
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
Prescribed anti-HTN medication for the indication of lowering blood pressure within 12 months prior to conception or prior to 20 weeks 0 days in the current pregnancy. Use during a prior pregnancy and through 12 weeks postpartum, or use for stage 1 chronic hypertension is not an exclusion.
Current use of anti-HTN medication. Participants on anti-HTN medication for the purpose of treating non-severe hypertensive disorders of pregnancy, or for indications other than hypertension, who are willing to go through a 48 hour washout before randomization would be eligible.
The George Washington University Biostatistics Center
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of Alabama at Birmingham
Collaborator
University of Utah
Collaborator
Brown University
Collaborator