Gestational Hypertension and Preeclampsia Blood Pressure (BP) Treatment Goals Less Than 140/90 vs. Less Than 160/110 mmHg: The GOALPOST Trial

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
The George Washington University Biostatistics Center
Study ID
NCT07746271
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Hypertension in Pregnancy
  • Obstetrical Complications

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 56 Years
Healthy Volunteers
Accepted

Interventions

  • Anti-hypertensive medication titrated to a BP goal of <140/90 mmHg — DRUG
    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 — OTHER
    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.

Study Details

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 Dates

First listed
Aug 5, 2026
Start date
Aug 15, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
4,120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Anti-hypertensive medication titrated to a BP goal of <140/90 mmHg
  • Other: Usual Care: Anti-hypertensive medication for BP ≥160/110 mmHg titrated to a goal of < 160/110 mmHg

Primary Outcome Measure

Number of participants with the adverse pregnancy composite [ Time Frame: Randomization to 6 weeks postpartum / 6 weeks of life (a period of up to 23 weeks) ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of Alabama - BirminghamBirminghamAlabama35233-
Regents of the University of California San FranciscoSan FranciscoCalifornia94143-
Northwestern UniversityChicagoIllinois60611-
Columbia UniversityNew YorkNew York10032-
University of North Carolina - Chapel HillChapel HillNorth Carolina27599-
Duke UniversityDurhamNorth Carolina27710-
Case Western Reserve UniversityClevelandOhio44109-
Ohio State UniversityColumbusOhio43210-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Magee Women's HospitalPittsburghPennsylvania15213-
Brown UniveristyProvidenceRhode Island02905-
Baylor College of MedicineHoustonTexas77030-
University of Texas - HoustonHoustonTexas77030-
University of UtahSalt Lake CityUtah84132-

Find similar trials in Birmingham, AL

By research site
University of Alabama - Birmingham· Birmingham, ALRegents of the University of California San Francisco· San Francisco, CANorthwestern University· Chicago, ILColumbia University· New York, NYUniversity of North Carolina - Chapel Hill· Chapel Hill, NCDuke University· Durham, NC

Related Studies