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Gestational Hypertension and Preeclampsia Blood Pressure (BP) Treatment Goals Less Than 140/90 vs. Less Than 160/110 mmHg: The GOALPOST Trial
Sponsor: 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.
Key Details
Gender
FEMALE
Age Range
14 Years - 56 Years
Study Type
INTERVENTIONAL
Enrollment
4120
Start Date
2026-08-15
Completion Date
2030-04-30
Last Updated
2026-08-05
Healthy Volunteers
Yes
Interventions
Anti-hypertensive medication titrated to a BP goal of <140/90 mmHg
Antihypertensive medication titrated to a BP goal of \< 140/90 mmHg initiated on labetalol or nifedipine ER following standard dosing guidelines. For first line treatment with labetalol, 200 mg twice daily will be initiated and escalated to a BP goal of \<140/90 mmHg to a maximum dose of 2,400 mg/day (1,200 mg twice daily or 800 mg three times daily). If a maximum daily dose of 2,400 mg or maximal tolerated dose of labetalol is reached without achieving goal BP \<140/90 mmHg, or at provider discretion, nifedipine ER can be added as a second agent and titrated as per the nifedipine ER algorithm outlined below. For first line treatment with nifedipine ER, dosing will be initiated at 30 mg daily and escalated to a goal BP \<140/90 mmHg to a maximum dose of 120 mg/day (120 mg daily or 60 mg twice daily). If the maximum daily dose or maximal tolerated dose of nifedipine ER is reached without achieving goal BP \<140/90, or at provider discretion, labetalol can be added as described above.
Usual Care: Anti-hypertensive medication for BP ≥160/110 mmHg titrated to a goal of < 160/110 mmHg
Usual care will not receive anti-hypertensive medication upon randomization. Participants will only be prescribed antihypertensive medication if their BP increases to ≥160/110 mmHg and titrated to a BP goal of \<160/110 mmHg. They will receive IV and/or oral anti-hypertensive medication as per local institutional protocols for management of severe range BP.
Locations (14)
University of Alabama - Birmingham
Birmingham, Alabama, United States
Regents of the University of California San Francisco
San Francisco, California, United States
Northwestern University
Chicago, Illinois, United States
Columbia University
New York, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
Brown Univeristy
Providence, Rhode Island, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas - Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States