Not yet recruitingPhase 3

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
14 Years to 56 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "One to two weeks after randomization, the participant should complete the Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) to assess quality of life."
  • "Newborn assessment will include the duration of hospitalization up to 6 weeks of life."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares blood pressure medicine with a goal below 140/90 to usual care without medicine while blood pressure stays below 160/110. It is for people who are 23 weeks to 35 weeks and 6 days pregnant and have new high blood pressure or preeclampsia without severe signs. Preeclampsia is a pregnancy-related blood pressure condition; the study checks whether treatment lowers the risk of serious pregnancy problems.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Pregnant with one baby or twins that each have their own outer pregnancy sac.
  • Between 23 weeks and 35 weeks and 6 days pregnant when assigned to a study group.
  • Diagnosed with pregnancy-related high blood pressure or preeclampsia without severe signs within the past 10 days.
  • New high blood pressure starting at 20 weeks or later: top number 140–159, bottom number 90–109, or both, on two checks at least 4 hours apart.
  • Normal lab tests for organ function. Protein in the urine may or may not be present.
  • Blood pressure checks must be recorded during medical visits, with at least one high reading at the study site.

Who can't join

  • Allergic to both labetalol and extended-release nifedipine, the blood pressure medicines.
  • Two blood pressure readings of 140/90 or higher, at least 4 hours apart, before 20 weeks of this pregnancy.
  • Certain past or current blood pressure medicine use. Exceptions include use during a past pregnancy and up to 12 weeks after birth, or for mild long-term high blood pressure. Some current users may qualify after a 48-hour break before group assignment.
  • Kidney disease, certain heart diseases, a past stroke, damage to the eye’s light-sensing layer, or sickle cell disease.
  • Severe preeclampsia signs, such as blood pressure of 160 or higher on top or 110 or higher on bottom, low platelets that help blood clot, kidney or liver problems, fluid in the lungs, lasting headache despite medicine, vision changes, or seizures.
  • Too little fluid around the baby, certain poor-growth findings, a known genetic disease or major birth defect in the baby, the baby’s death, or a planned end to the pregnancy.
  • A planned delivery for medical reasons before 37 weeks, or plans to give birth outside a study hospital.
  • Taking part in another treatment study that affects this study’s main results, unless approved as an exception, or having joined this trial in a past pregnancy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (14)

AL

CA

IL

NC

NY

OH

PA

RI

TX

UT