Manual Versus Instrumental Rotation of the Fetal Head in Malposition at Birth (ROTATE Study): Protocol for a Randomized Controlled Trial

Dawn Parris   ¹ , MBChB ;   Raffaele Napolitano   ¹ , MD, PhD ;   Jonathan Bishop   ² , PhD ;   Annette Briley   ³ , PhD ;   Laura Butler   ² , BSc ;   Versha Cheed   ⁴ , MSc, BSc ;   Anna L David   ⁵ , PhD, MBBS, BSc ;   Zaina Habib   ² , MSci ;   Pollyanna Hardy   ⁶ , MSc, BSc ;   Kim Hinshaw   ⁷ , MBBS ;   Laura L Jones   ⁸ , PhD, BSc, DPS ;   Rachel Lillywhite   ² , BA ;   Eleanor Molloy   ⁸ , PhD, BSc, MSc ;   Jacqueline Nicholls   ⁵ , PhD ;   Stephen O'Brien   ⁹ , PhD, BMBS ;   Rachel Plachcinski   ¹⁰ , MSc ;   Andrew Shennan   ¹¹ , MD, MBBS ;   Nigel Simpson   ¹² , MBBS ;   Maureen Treadwell   ¹³ , QTS ;   Bassel Wattar   ^{14, 15, 16} , PhD, MD ;   Andrew Weeks   ¹⁷ , MBChB, MD ;   The ROTATE Study Group   ^{4, 5} ;   Dimitrios Siassakos   ⁵ , MD, MBBS, MSc

¹ Maternal Fetal Medicine, Elizabeth Garrett Anderson (EGA) Institute for Women's Health, University College London, London, United Kingdom

² Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom

³ Caring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, Australia

⁴ Department of Applied Health Sciences, Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom

⁵ EGA Institute for Women's Health, University College London, London, United Kingdom

⁶ Nuffield Department of Population Health, National Perinatal Epidemiology Unit Clinical Trials Unit (NPEU CTU), University of Oxford, Oxford, United Kingdom

⁷ Obstetrics and Gynaecology, Sunderland Royal Hospital, Sunderland, United Kingdom

⁸ Department of Applied Health Sciences, School of Health Sciences, University of Birmingham, Birmingham, United Kingdom

⁹ Obstetrics and Gynaecology, North Bristol NHS Trust, Bristol, United Kingdom

¹⁰ National Childbirth Trust, London, United Kingdom

¹¹ Women and Children’s Health, King's College London, London, United Kingdom

¹² School of Medicine, University of Leeds, Leeds, United Kingdom

¹³ Birth Trauma Association, Derbyshire, United Kingdom

¹⁴ Clinical Trials Unit, Anglia Ruskin University, Cambridge, United Kingdom

¹⁵ Beginnings Assisted Conception Unit, Epsom and St Helier University Hospitals NHS Trust, London, United Kingdom

¹⁶ Comprehensive Clinical Trials Unit, University College London, London, United Kingdom

¹⁷ Women's and Children's Health, Institute of Life Course & Medical Sciences, University of Liverpool, Liverpool, United Kingdom