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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

Sponsored by The George Washington University Biostatistics Center

About this study

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.

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: defined as no antihypertensive medication unless BP increases to greater than or equal to 160 mmHg systolic pressure or 110 mmHg diastolic to achieve a target BP of less than 160/110 mmHg. Participants ra…

Where this study is enrolling (3)

Who can participate

Inclusion criteria

  • ✓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

Exclusion criteria

  • ✕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.
  • ✕Planned indicated delivery prior to 37 weeks 0 days
  • ✕Participation in another interventional study that influences the primary outcome in this study. This may not apply to comparative effectiveness studies evaluating treatments that are available and used as part of clinical practice. Such cases will be adjudicated by the Concurrent Research Committee and Protocol Subcommittee.
  • ✕Plan to deliver at a non-participating site
  • ✕Participation in this trial in a previous pregnancy

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.