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

Starting soon · Phase 3

Conditions studied: Hypertension in Pregnancy, Obstetrical Complications

In brief

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 facts

Study ID: NCT07746271
Run by: The George Washington University Biostatistics Center
People needed: 4120
Starts: 2026-08-15
Expected to finish: 2030-04-30
Last updated by the study team: 2026-08-05

Who can join

Age: 14 and older, up to 56. Sex: female. Healthy volunteers: accepted.

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:
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.
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
Impaired liver function defined as an elevated blood concentration of liver transaminases to twice normal concentration, or by severe persistent right upper quadrant or epigastric pain
Pulmonary edema
New onset headache unresponsive to medication and not accounted for by alternative diagnoses
Visual disturbances
Eclampsia
Oligohydramnios defined as a maximum vertical pocket (MVP) <2 cm or an amniotic fluid index (AFI) < 5 cm
Fetal growth restriction defined as estimated fetal weight < 5th percentile, or fetal growth restriction <10th percentile (estimated fetal weight <10th percentile or abdominal circumference < 10th percentile) with abnormal umbilical artery dopplers (elevated (S/D ratio >95th percentile for gestational age), absent or reversed end diastolic flow)
Known fetal genetic disease or major malformations
Fetal demise or planned termination of pregnancy.

Where it is running

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

Full record on ClinicalTrials.gov

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