[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The George Washington University Biostatistics Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":100},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":21,"type":22},4120,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Hypertension in Pregnancy","Obstetrical Complications",[31,32,33,34,35],"Preeclampsia","Preterm Delivery","Maternal Morbidity","Neonatal Morbidity","Prevention","NOT_YET_RECRUITING","2026-07-30",{"date":39,"type":40},"2026-08-05","ACTUAL",{"date":42,"type":22},"2026-08-15",{"date":44,"type":22},"2030-04-30",{"name":46,"class":47},"The George Washington University Biostatistics Center","OTHER",14,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":48},"100591407","phase-3-aspirin-dose-escalation-for-the-prevention-of-recurrent-preterm-delivery-trial-100591407","NCT06980025","Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial","A Dose Escalation Study of Low Dose Aspirin for the Prevention of Recurrent Preterm Birth","ADEPT","Inclusion Criteria:\n\n* 14 years or older\n* Singleton gestation. Twin gestation reduced to a singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 13 weeks 6 days project gestational age. Higher-order multifetal gestations reduced to singletons are not eligible.\n* Gestational age at randomization between 10 weeks 0 days and 15 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.\n* Prior preterm birth between 20 weeks 0 days and 34 weeks 6 days with one of the following in the proximal birth reaching 20 weeks or greater:\n\n  * Spontaneous preterm birth is defined as spontaneous preterm labor or premature rupture of membranes\n  * Ischemic placental disease is defined as preeclampsia, small for gestational age, fetal growth restriction, or placental abruption, as defined clinically.\n  * Stillbirth excluding those with known genetic disorders or major congenital anomalies.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., history of peptic ulcer disease, nasal polyps, NSAID-induced asthma, history of gastrointestinal bleeding, known G6PD deficiency, severe hepatic dysfunction, bleeding disorders, and consumption of 3 or more alcoholic drinks per day)\n* Taking other anticoagulants such as Heparin or Low-Molecular weight Heparin\n* Thrombocytopenia defined as a platelet count defined as a platelet count \\\u003C100,000 microliters\n* Gastric bypass surgery, regardless of type\n* Aspirin use \\>81 mg daily during the current pregnancy who are not willing or able to go through a 2-week washout before randomization.\n* Known major Mullerian anomaly of the uterus (specifically bicornuate, unicornuate, or uterine septum not resected) due to increased risk of preterm delivery.\n* Known fetal genetic disease or major malformations\n* Fetal demise or planned termination of pregnancy. Selective reduction by 13 weeks 6 days gestation, from twins to singleton, is not an exclusion.\n* Any fetal\u002Fmaternal condition requiring invasive in-utero assessment or treatment, for example, significant red cell antigen sensitization or neonatal alloimmune thrombocytopenia.\n* Patients with any of the following medical conditions because of increased risk for adverse pregnancy outcome or indicated preterm birth:\n\n  * Treated hypertension requiring more than one agent\n  * Chronic renal disease with baseline serum creatinine ≥1.5 mg\u002FdL\n  * Conditions treated with chronic oral glucocorticoid therapy (e.g., systemic lupus erythematosus)\n  * Uncontrolled hyper- and hypothyroid disease\n  * New York Heart Association (NYHA) stage II or greater cardiac disease\n* Planned indicated delivery prior to 37 weeks.\n* Participation in another interventional study that influences the primary outcome in this study (gestational age at delivery).\n* Participation in this trial in a previous pregnancy.\n* Delivery planned at a non-participating site",{"count":58,"type":22},1800,[25],"This is a phase-III multi-center double-blind randomized clinical trial of 1,800 individuals with a history of prior preterm birth at less than 35 weeks gestation who are randomized to either 162 mg aspirin or 81 mg aspirin daily. The study drug will be initiated between 10 and 15 weeks gestation and continued through 36 weeks, 6 days gestation. The primary endpoint is recurrent preterm delivery or fetal death prior to 35 weeks, 0 days gestation.",[32,29],[32,63,33,34,35],"Stillbirth","RECRUITING","2026-04-03",{"date":67,"type":40},"2026-04-09",{"date":69,"type":40},"2025-07-01",{"date":71,"type":22},"2029-02-28",{"name":46,"class":47},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":48},"100562588","phase-3-azithromycin-prophylaxis-for-prelabor-cesarean-delivery-trial-100562588","NCT06605118","Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial","Azithromycin Prophylaxis for Prelabor Cesarean Delivery Trial","PRECEDE","Inclusion Criteria:\n\n* ≥ 23 weeks' gestation (ACOG dating criteria)\n* Scheduled or prelabor cesarean delivery\n* Singleton or twin gestation\n\nExclusion Criteria:\n\n* Allergy or contraindication to azithromycin or macrolide antibiotics, including those with a history of cholestatic jaundice\u002Fhepatic dysfunction associated with prior use of azithromycin\n* Chorioamnionitis\n* Bacterial infection (e.g., pyelonephritis) requiring ongoing antibiotic treatment after delivery\n* Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change)\n* Fetal demise or known major congenital anomaly\n* Azithromycin treatment within 7 days\n* Planned use of antimicrobial prophylaxis after delivery for any reason\n* Known structural heart disease or active cardiomyopathy (current ejection fraction\\\u003C40%)\n* Known arrhythmia with QT prolongation or taking scheduled medications known to prolong the QT interval such that it would preclude the use of azithromycin\n* Refusal or unable to obtain consent (e.g., language barrier)\n* Participating in another intervention study that influences the primary outcome in this study\n* Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded.",{"count":82,"type":22},8000,[25],"This is a phase-III multi-center double-blind randomized controlled trial of 8,000 individuals undergoing a scheduled or prelabor cesarean delivery who are randomized to either adjunctive azithromycin prophylaxis or to placebo. Both groups also will receive standard of care preoperative antibiotics (excluding azithromycin). The primary endpoint is a maternal infection composite defined as any one of the following up to 6 weeks postpartum: endometritis, wound infection, abscess, septic thrombosis, sepsis, pneumonia, pyelonephritis and breast infection.",[29,86,87],"Labor and Delivery Complication","Cesarean Delivery",[89,90,91,92,93],"cesarean delivery","infection","maternal morbidity","antibiotics","prevention",{"date":67,"type":40},{"date":96,"type":40},"2024-11-06",{"date":98,"type":22},"2027-11-30",{"name":46,"class":47},""]