[{"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:":103},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100591407","phase-3-aspirin-dose-escalation-for-the-prevention-of-recurrent-preterm-delivery-trial-100591407",false,"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",true,"FEMALE","14 Years",{"count":21,"type":22},1800,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","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.",[28,29],"Preterm Delivery","Obstetrical Complications",[28,31,32,33,34],"Stillbirth","Maternal Morbidity","Neonatal Morbidity","Prevention","RECRUITING","2026-04-03",{"date":38,"type":39},"2026-04-09","ACTUAL",{"date":41,"type":39},"2025-07-01",{"date":43,"type":22},"2029-02-28",{"name":45,"class":46},"The George Washington University Biostatistics Center","OTHER",14,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":47},"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":57,"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.",[29,61,62],"Labor and Delivery Complication","Cesarean Delivery",[64,65,66,67,68],"cesarean delivery","infection","maternal morbidity","antibiotics","prevention",{"date":38,"type":39},{"date":71,"type":39},"2024-11-06",{"date":73,"type":22},"2027-11-30",{"name":45,"class":46},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":47},"100323149","continuous-positive-airway-pressure-cpap-for-sleep-apnea-in-pregnancy-100323149","NCT03487185","Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy","A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy","SLEEP","Inclusion Criteria\n\n1. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.\n2. Gestational age at randomization between 14 weeks 0 days and 21 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.\n3. Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and \\\u003C30.\n\nExclusion Criteria\n\n1. Previously prescribed, current or planned therapy for sleep apnea.\n2. Age \\\u003C 18 years, because the rate of sleep apnea in this population is extremely low.\n3. Inability to sleep in a stable place with access to the CPAP machine at least 5 nights per week.\n4. Asthma requiring systemic steroid therapy for more than 14 days within the past 6 months because this population is expected to be unresponsive to CPAP therapy.\n5. Current use of prescribed sleeping pills for insomnia.\n6. Chronic medical conditions requiring oxygen supplementation (e.g. pulmonary fibrosis, pulmonary hypertension, cystic fibrosis) because this population is expected to be unresponsive to CPAP therapy.\n7. Chronic renal disease with serum creatinine \\>1.3 mg\u002FdL because the primary outcome would be pre-determined.\n8. Antiphospholipid antibody syndrome, because it would compromise the primary outcome diagnosis.\n9. History of medical complications such as:\n\n   1. Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)\n   2. Thrombocytopenia with platelet count \\\u003C100,000 because of the difficulty in assessing the primary outcome.\n10. Active vaginal bleeding (more than spotting) at the time of randomization.\n11. Known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy because inclusion would compromise evaluation of secondary neonatal outcomes.\n12. Known major uterine malformations associated with adverse pregnancy outcomes.\n13. Current use of opiates (heroin, methadone, or other daily opioid use) due to inaccuracy of the home sleep test and inefficiency of CPAP.\n14. Active drug use, alcohol use, or unstable psychiatric condition.\n15. Participation in another interventional study that influences preeclampsia, hypertensive disorders of pregnancy, or GDM.\n16. Prenatal care or delivery planned at a non-network center where access to the complete electronic medical record will not be available to research staff.\n17. Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.","18 Years",{"count":85,"type":22},1500,[87],"NA","A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.",[90,91,29],"Obstructive Sleep Apnea of Adult","Preeclampsia",[93,94,95],"CPAP","Apnea","pregnancy",{"date":97,"type":39},"2026-04-06",{"date":99,"type":39},"2018-08-03",{"date":101,"type":22},"2026-12-31",{"name":45,"class":46},""]