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Design and conduct of a large obstetric or neonatal randomized controlled trial
Institution:1. WINNER Centre for Newborn Research, NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia;2. Miracle Babies Foundation, Chipping Norton, Sydney, NSW 2170, Australia;3. Kolling Institute of Medical Research, University of Sydney, Royal North Shore Hospital, Sydney, NSW 2065, Australia;1. Department of Obstetrics & Gynaecology, Dalhousie University, Halifax NS;2. Department of Pediatrics, Dalhousie University, Halifax NS;1. Medical Technology and Practice Patterns Institute, Bethesda, MD;2. VA NY Harbor Healthcare System and New York University School of Medicine, New York, NY;1. Department of Maternal-Fetal Medicine, Women’s Health Service Line, Geisinger Health System, Danville, PA;2. Department of Obstetrics and Gynecology, Columbia University, New York, NY;1. Barts Health NHS Trust, Royal London Hospital, Whitechapel, London, E1 1BB, United Kingdom;2. Clinical Biostatistics Unit, Hospital Ramon y Cajal, (IRYCIS) Madrid, Spain and CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain;3. Women’s Health Research Unit, Multidisciplinary Evidence Synthesis Hub (mEsh), Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, United Kingdom;4. Barts Health NHS Trust, Newham University Hospital, Plaistow, London, E13 8SL, United Kingdom;1. Centro de Investigaciones Geológicas (CONICET–UNLP), Diag. 113 # 275, La Plata, 1900, Argentina;2. División Paleontología Vertebrados, Unidades de Investigación Anexo Museo de La Plata, Facultad de Ciencias Naturales y Museo, UNLP. CONICET. 122 y 60, La Plata, 1900, Argentina;3. INGEOSUR-CONICET, Departamento de Geología, Universidad Nacional del Sur. San Juan 670, Bahía Blanca, 8000, Argentina;4. INCITAP (CONICET-UNLPam), Universidad Nacional de La Pampa, Mendoza 109, Santa Rosa, 6300, Argentina;5. División Paleontología Vertebrados, Museo de La Plata, CIC. Paseo Del Bosque s/n, La Plata, 1900, Argentina;6. University of Lethbridge, 4401 University Drive, Lethbridge, Alberta, T1K 3M4, Canada;7. CADIC-CONICET, Laboratorio de Geomorfología y Cuaternario, Universidad Nacional de Tierra del Fuego, Bernardo Houssay 200, Ushuaia, 9410, Argentina;1. Department of Obstetrics and Gynecology, Faculty of Health Sciences, Soroka University Medical Center, Ben-Gurion University of the Negev, Beer-Sheva, Israel;2. Department of Epidemiology and Health Services Evaluation, Ben-Gurion University of the Negev, Beer-Sheva, Israel
Abstract:
Keywords:Randomized controlled trials  Cluster trials  Cross-over cluster trials  Recruitment  Comparative effectiveness research  Informed consent
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