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

NCT07746271 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: HD114633-GOALPOSTU01HD114633U24HD036801
• Study Type: interventional
• Target: 4,120
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Obstetrical Complications; Hypertension in Pregnancy

Keywords

Preeclampsia; Preterm Delivery; Maternal Morbidity; Neonatal Morbidity; Prevention

Outcome Measures

Primary Outcomes (1)

• Number of participants with the adverse pregnancy composite

  Number of participants with preeclampsia with severe features (excluding severe hypertension), medically indicated preterm birth less than 37 weeks 0 days, fetal or neonatal death, placental abruption.

  Randomization to 6 weeks postpartum / 6 weeks of life (a period of up to 23 weeks)

Secondary Outcomes (23)

• Number of participants with the adverse perinatal composite outcome

  Randomization to 6 weeks of life (a period of up to 23 weeks)

• Number of participants with preeclampsia with severe features

  Randomization to 6 weeks postpartum (a period of up to 23 weeks)

• Number of perinatal deaths

  Randomization to 28 days of life (a period of up to 147 days)

• Number of neonates who were small for gestational age <3rd percentile

  At birth

• Number of neonates who were small for gestational age <10th percentile for gestational age

  At birth

Other Outcomes (1)

• Number of participants with adverse pregnancy composite by race/ethnicity

  Randomization to 6 weeks postpartum / 6 weeks of life

Study Arms (2)

Anti-hypertensive medication titrated to a BP goal of <140/90 mmHg

EXPERIMENTAL

Drug: Anti-hypertensive medication titrated to a BP goal of <140/90 mmHg

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

OTHER

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

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.

Also known as: Labetalol, Nifedipine ER

Anti-hypertensive medication titrated to a BP goal of <140/90 mmHg

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.

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

Eligibility Criteria

• Age: 14 Years - 56 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Blood pressure measurements used for the diagnosis must occur during a formal clinical assessment in the outpatient, inpatient, or emergency care setting and be documented in the medical record. The diagnosis is made on the date of the second qualifying blood pressure.
• At least 1 elevated blood pressure (systolic blood pressure 140-159 and/or diastolic blood pressure 90-109) must be documented at the recruitment site

You may not qualify if:

• 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:
• 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.
• 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
• Chronic kidney disease including any of the following lab values prior to 20 weeks gestation: proteinuria ≥ 300mg/24 hr, clean catch protein creatinine ratio ≥ 0.3, or serum creatinine \>1.1
• Cardiac disorders including cardiomyopathy, angina, and coronary artery disease
• Prior stroke
• Retinopathy
• Sickle cell disease
• 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:
• Thrombocytopenia defined as a platelet count \<100,000
• Renal insufficiency defined as a serum creatinine \>1.1 mg/dL or a doubling of the concentration in the absence of other renal disease

Sponsors & Collaborators

• The George Washington University Biostatistics Center: lead
• University of Alabama at Birmingham: collaborator
• University of Utah: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Brown University: collaborator

Study Sites (14)

University of Alabama - Birmingham

Birmingham, Alabama, 35233, United States

Location

Regents of the University of California San Francisco

San Francisco, California, 94143, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44109, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Brown Univeristy

Providence, Rhode Island, 02905, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas - Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia; Premature Birth

Interventions

Labetalol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Study Officials

• Rebecca G Clifton, PhD

  The George Washington University Biostatistics Center

  PRINCIPAL INVESTIGATOR

• Rachel G Sinkey, MD

  University of Alabama at Birmingham

  STUDY CHAIR

• Laurie B Griffin, MD

  University of Utah Health Sciences

  STUDY CHAIR

• Dwight J Rouse, MD

  Brown University

  PRINCIPAL INVESTIGATOR

• Alan TN Tita, MD PHD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca G Clifton, PhD

CONTACT

202-242-2945; rclifton@bsc.gwu.edu

Roja Kambhampati, MSHS

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individuals will be randomized between 23 weeks, 0 days and 35 weeks, 0 days gestation to either antihypertensive medication (labetalol or nifedipine extended release) titrated to a BP goal of \<140/90 or to usual care - no treatment of non-severe hypertension (i.e. no anti-hypertensive medication unless BP ≥160/110 to a goal BP \<160/110 mmHg).

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 5, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): April 30, 2030
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (14)