Gestational Hypertension and Preeclampsia Blood Pressure (BP) Treatment Goals Less Than 140/90 vs. Less Than 160/110 mmHg: The GOALPOST Trial
The George Washington University Biostatistics Center
Summary
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.
Description
All women with a diagnosis of gestational hypertension or preeclampsia without severe features at an Maternal-Fetal Medicine Units Network (MFMU) Center outpatient or inpatient setting who are less than 36 weeks and 0 days of gestation will be screened for eligibility and approached for enrollment by the MFMU Research Team. Women who meet study eligibility and want to participate will provide written informed consent. Study participants will be randomized 1:1 to: 1. intervention: antihypertensive medication to achieve a target blood pressure (BP) lower than 140/90 mmHg or 2. usual care: defin…