[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650459":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":29,"centralContacts":45,"locations":52,"responsibleParty":187,"collaborators":189,"id":196,"slug":197,"hasResults":198,"nctId":199,"briefTitle":200,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":203,"sex":204,"minAge":205,"maxAge":206,"enrollmentInfo":207,"targetDuration":11,"studyType":210,"phases":211,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":223,"whyStopped":11,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},{"fullName":5,"class":6},"The George Washington University Biostatistics Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Anti-hypertensive medication titrated to a BP goal of \u003C140\u002F90 mmHg","EXPERIMENTAL",null,[13],"Drug: Anti-hypertensive medication titrated to a BP goal of \u003C140\u002F90 mmHg",{"label":15,"type":6,"description":11,"interventionNames":16},"Usual Care: Anti-hypertensive medication for BP ≥160\u002F110 mmHg titrated to a goal of \u003C 160\u002F110 mmHg",[17],"Other: Usual Care: Anti-hypertensive medication for BP ≥160\u002F110 mmHg titrated to a goal of \u003C 160\u002F110 mmHg",[19,26],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Antihypertensive medication titrated to a BP goal of \\\u003C 140\u002F90 mmHg initiated on labetalol or nifedipine ER following standard dosing guidelines.\n\nFor first line treatment with labetalol, 200 mg twice daily will be initiated and escalated to a BP goal of \\\u003C140\u002F90 mmHg to a maximum dose of 2,400 mg\u002Fday (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 \\\u003C140\u002F90 mmHg, or at provider discretion, nifedipine ER can be added as a second agent and titrated as per the nifedipine ER algorithm outlined below.\n\nFor first line treatment with nifedipine ER, dosing will be initiated at 30 mg daily and escalated to a goal BP \\\u003C140\u002F90 mmHg to a maximum dose of 120 mg\u002Fday (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 \\\u003C140\u002F90, or at provider discretion, labetalol can be added as described above.",[9],[24,25],"Labetalol","Nifedipine ER",{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":11},"Usual care will not receive anti-hypertensive medication upon randomization. Participants will only be prescribed antihypertensive medication if their BP increases to ≥160\u002F110 mmHg and titrated to a BP goal of \\\u003C160\u002F110 mmHg. They will receive IV and\u002For oral anti-hypertensive medication as per local institutional protocols for management of severe range BP.",[15],[30,33,37,40,43],{"name":31,"affiliation":5,"role":32},"Rebecca G Clifton, PhD","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":36},"Rachel G Sinkey, MD","University of Alabama at Birmingham","STUDY_CHAIR",{"name":38,"affiliation":39,"role":36},"Laurie B Griffin, MD","University of Utah Health Sciences",{"name":41,"affiliation":42,"role":32},"Dwight J Rouse, MD","Brown University",{"name":44,"affiliation":35,"role":32},"Alan TN Tita, MD PHD",[46,50],{"name":31,"role":47,"phone":48,"phoneExt":11,"email":49},"CONTACT","202-242-2945","rclifton@bsc.gwu.edu",{"name":51,"role":47,"phone":11,"phoneExt":11,"email":11},"Roja Kambhampati, MSHS",[53,66,76,86,95,105,114,124,133,143,152,162,172,177],{"facility":54,"status":11,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":11},"University of Alabama - Birmingham","Birmingham","Alabama","35233","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-86.80249,33.52066,{"lat":64,"lon":63},{"facility":67,"status":11,"city":68,"state":69,"zip":70,"country":58,"countryCode":59,"cosmosGeoPoint":71,"geoPoint":75,"contacts":11},"Regents of the University of California San Francisco","San Francisco","California","94143",{"type":61,"coordinates":72},[73,74],-122.41942,37.77493,{"lat":74,"lon":73},{"facility":77,"status":11,"city":78,"state":79,"zip":80,"country":58,"countryCode":59,"cosmosGeoPoint":81,"geoPoint":85,"contacts":11},"Northwestern University","Chicago","Illinois","60611",{"type":61,"coordinates":82},[83,84],-87.65005,41.85003,{"lat":84,"lon":83},{"facility":87,"status":11,"city":88,"state":88,"zip":89,"country":58,"countryCode":59,"cosmosGeoPoint":90,"geoPoint":94,"contacts":11},"Columbia University","New York","10032",{"type":61,"coordinates":91},[92,93],-74.00597,40.71427,{"lat":93,"lon":92},{"facility":96,"status":11,"city":97,"state":98,"zip":99,"country":58,"countryCode":59,"cosmosGeoPoint":100,"geoPoint":104,"contacts":11},"University of North Carolina - Chapel Hill","Chapel Hill","North Carolina","27599",{"type":61,"coordinates":101},[102,103],-79.05584,35.9132,{"lat":103,"lon":102},{"facility":106,"status":11,"city":107,"state":98,"zip":108,"country":58,"countryCode":59,"cosmosGeoPoint":109,"geoPoint":113,"contacts":11},"Duke University","Durham","27710",{"type":61,"coordinates":110},[111,112],-78.89862,35.99403,{"lat":112,"lon":111},{"facility":115,"status":11,"city":116,"state":117,"zip":118,"country":58,"countryCode":59,"cosmosGeoPoint":119,"geoPoint":123,"contacts":11},"Case Western Reserve University","Cleveland","Ohio","44109",{"type":61,"coordinates":120},[121,122],-81.69541,41.4995,{"lat":122,"lon":121},{"facility":125,"status":11,"city":126,"state":117,"zip":127,"country":58,"countryCode":59,"cosmosGeoPoint":128,"geoPoint":132,"contacts":11},"Ohio State University","Columbus","43210",{"type":61,"coordinates":129},[130,131],-82.99879,39.96118,{"lat":131,"lon":130},{"facility":134,"status":11,"city":135,"state":136,"zip":137,"country":58,"countryCode":59,"cosmosGeoPoint":138,"geoPoint":142,"contacts":11},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":61,"coordinates":139},[140,141],-75.16362,39.95238,{"lat":141,"lon":140},{"facility":144,"status":11,"city":145,"state":136,"zip":146,"country":58,"countryCode":59,"cosmosGeoPoint":147,"geoPoint":151,"contacts":11},"Magee Women's Hospital","Pittsburgh","15213",{"type":61,"coordinates":148},[149,150],-79.99589,40.44062,{"lat":150,"lon":149},{"facility":153,"status":11,"city":154,"state":155,"zip":156,"country":58,"countryCode":59,"cosmosGeoPoint":157,"geoPoint":161,"contacts":11},"Brown Univeristy","Providence","Rhode Island","02905",{"type":61,"coordinates":158},[159,160],-71.41283,41.82399,{"lat":160,"lon":159},{"facility":163,"status":11,"city":164,"state":165,"zip":166,"country":58,"countryCode":59,"cosmosGeoPoint":167,"geoPoint":171,"contacts":11},"Baylor College of Medicine","Houston","Texas","77030",{"type":61,"coordinates":168},[169,170],-95.36327,29.76328,{"lat":170,"lon":169},{"facility":173,"status":11,"city":164,"state":165,"zip":166,"country":58,"countryCode":59,"cosmosGeoPoint":174,"geoPoint":176,"contacts":11},"University of Texas - Houston",{"type":61,"coordinates":175},[169,170],{"lat":170,"lon":169},{"facility":178,"status":11,"city":179,"state":180,"zip":181,"country":58,"countryCode":59,"cosmosGeoPoint":182,"geoPoint":186,"contacts":11},"University of Utah","Salt Lake City","Utah","84132",{"type":61,"coordinates":183},[184,185],-111.89105,40.76078,{"lat":185,"lon":184},{"type":188,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[190,193,194,195],{"name":191,"class":192},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":35,"class":6},{"name":178,"class":6},{"name":42,"class":6},"100650459","phase-3-gestational-hypertension-and-preeclampsia-blood-pressure-bp-treatment-goals-less-than-14090-vs-less-than-160110-mmhg-the-goalpost-trial-100650459",false,"NCT07746271","Gestational Hypertension and Preeclampsia Blood Pressure (BP) Treatment Goals Less Than 140\u002F90 vs. Less Than 160\u002F110 mmHg: The GOALPOST Trial","GOALPOST","INCLUSION CRITERIA:\n\n* Singleton or di-chorionic twin gestation.\n* Gestational age at randomization from 23 weeks 0 days through 35 weeks 6 days based on clinical information and evaluation of the earliest ultrasound\n* Diagnosis of gestational hypertension or preeclampsia without severe features within 10 days prior to randomization.\n\n  * 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.\n  * 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.\n  * At least 1 elevated blood pressure (systolic blood pressure 140-159 and\u002For diastolic blood pressure 90-109) must be documented at the recruitment site\n\nEXCLUSION CRITERIA:\n\n* Known allergy or hypersensitivity to both labetalol and nifedipine ER\n* Two blood pressure measurements ≥ 140\u002F90 at least 4 hours apart prior to 20 weeks 0 days in the current pregnancy\n* History or current use of anti-HTN medication defined as any of the following:\n\n  * 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.\n  * 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.\n* High-risk co-morbidities for which treatment at a lower blood pressure level (i.e., below the standard cutoff of 160\u002F110) may be indicated\n\n  * Chronic kidney disease including any of the following lab values prior to 20 weeks gestation: proteinuria ≥ 300mg\u002F24 hr, clean catch protein creatinine ratio ≥ 0.3, or serum creatinine \\>1.1\n  * Cardiac disorders including cardiomyopathy, angina, and coronary artery disease\n  * Prior stroke\n  * Retinopathy\n  * Sickle cell disease\n\nPreeclampsia with severe features defined as any of the following:\n\n* 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.\n* Severe features of preeclampsia as evidenced by end organ damage defined as any of the following on or after 20 weeks 0 days gestation:\n\n  * Thrombocytopenia defined as a platelet count \\\u003C100,000\n  * Renal insufficiency defined as a serum creatinine \\>1.1 mg\u002FdL or a doubling of the concentration in the absence of other renal disease\n  * 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\n  * Pulmonary edema\n  * New onset headache unresponsive to medication and not accounted for by alternative diagnoses\n  * Visual disturbances\n* Eclampsia\n\n  * Oligohydramnios defined as a maximum vertical pocket (MVP) \\\u003C2 cm or an amniotic fluid index (AFI) \\\u003C 5 cm\n  * Fetal growth restriction defined as estimated fetal weight \\\u003C 5th percentile, or fetal growth restriction \\\u003C10th percentile (estimated fetal weight \\\u003C10th percentile or abdominal circumference \\\u003C 10th percentile) with abnormal umbilical artery dopplers (elevated (S\u002FD ratio \\>95th percentile for gestational age), absent or reversed end diastolic flow)\n  * Known fetal genetic disease or major malformations\n  * Fetal demise or planned termination of pregnancy.\n  * Planned indicated delivery prior to 37 weeks 0 days\n  * 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.\n  * Plan to deliver at a non-participating site\n  * Participation in this trial in a previous pregnancy",true,"FEMALE","14 Years","56 Years",{"count":208,"type":209},4120,"ESTIMATED","INTERVENTIONAL",[212],"PHASE3","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 \\\u003C140\u002F90 mmHg or to no treatment for non-severe hypertension \\\u003C 160\u002F110 mmHg (usual care). The primary endpoint is an adverse pregnancy composite comprised of preeclampsia with end-organ damage, medically indicated preterm delivery \\\u003C37 weeks 0 days gestation, fetal\u002Fneonatal\u002Finfant death, or placental abruption.",[215,216],"Hypertension in Pregnancy","Obstetrical Complications",[218,219,220,221,222],"Preeclampsia","Preterm Delivery","Maternal Morbidity","Neonatal Morbidity","Prevention","NOT_YET_RECRUITING","2026-07-30",{"date":226,"type":227},"2026-08-05","ACTUAL",{"date":229,"type":209},"2026-08-15",{"date":231,"type":209},"2030-04-30",{"name":5,"class":6},14]