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A Randomized Trial of Progesterone in Women with Bleeding in Early Pregnancy

Arri Coomarasamy ... 妇产科和儿科 • 2019.05.09






我们在妊娠早期阴道出血的女性中开展了一项多中心、随机、双盲、安慰剂对照试验,比较了孕酮与安慰剂的效果。参与试验的女性被随机分组,在因出血就诊至妊娠16周期间,分别每日2次使用含有400 mg孕酮或匹配安慰剂的阴道栓剂。主要结局是妊娠至少34周后活产。在有主要结局数据的所有参与者中进行了主要分析。通过对缺失数据进行多重填补,在全部参与者中对主要结局进行了敏感性分析。



在英国48家医院招募的总共4,153名女性被随机分组,分别接受孕酮(2,079名女性)或安慰剂(2,074名女性)治疗。有主要结局数据的女性百分比为97%(4,153名女性中的4,038名)。在孕酮组和安慰剂组中,妊娠至少34周后的活产率分别为75%(2,025名女性中的1,513名)和72%(2,013名女性中的1,459名)(相对率,1.03;95%置信区间[CI],1.00~1.07;P=0.08)。对缺失的主要结局数据进行填补的敏感性分析获得了类似结果(相对率,1.03;95% CI,1.00~1.07;P=0.08)。不良事件发生率无显著组间差异。



在妊娠早期出血的女性中,妊娠早期给予孕酮未达到显著高于安慰剂的活产率(由英国国家卫生研究院卫生技术评估[United Kingdom National Institute for Health Research Health Technology Assessment]计划资助;PRISM在Current Controlled Trials注册号为ISRCTN14163439)。


Arri Coomarasamy, M.B., Ch.B., M.D., F.R.C.O.G., Adam J. Devall, B.Med.Sci., Ph.D., Versha Cheed, M.Sc., Hoda Harb, M.B., Ch.B., Ph.D., Lee J. Middleton, B.Sc., Ioannis D. Gallos, D.M.S., M.D., Helen Williams, B.Sc., Abey K. Eapen, M.D., Ph.D., Tracy Roberts, Ph.D., R.G.N., Chriscasimir C. Ogwulu, Ph.D., Ilias Goranitis, Ph.D., Jane P. Daniels, M.Med.Sci., Ph.D., Amna Ahmed, M.B., B.S., M.R.C.O.G., Ruth Bender-Atik, B.A., Kalsang Bhatia, M.B., B.S., F.R.C.O.G., Cecilia Bottomley, DM.B.B.Chir., M.R.C.O.G., M.D., Jane Brewin, B.A., Meenakshi Choudhary, M.B., B.S., M.D., M.R.C.O.G., Ph.D., Fiona Crosfill, M.B., B.S., M.R.C.O.G., Dip.Med.Ed., Shilpa Deb, M.B., B.S., M.R.C.O.G., D.G.O., Ph.D., W. Colin Duncan, M.B., Ch.B., M.D., F.R.C.O.G., Andrew Ewer, M.B., Ch.B., M.D., M.R.C.P., F.R.C.P.C.H., Kim Hinshaw, M.B., B.S., F.R.C.O.G., Tom Holland, M.B., B.S., M.R.C.O.G., M.D., Feras Izzat, M.B., Ch.B., M.R.C.O.G., Jemma Johns, M.B., B.S., M.R.C.O.G., M.D., Kathiuska Kriedt, M.B., B.S., Mary-Ann Lumsden, M.B., B.S., M.D., F.R.C.O.G., Padma Manda, M.B., B.S., D.G.O., D.F.F.P., F.R.C.O.G., Jane E. Norman, M.B., Ch.B., M.D., F.R.C.O.G., F. Med.Sci., F.R.C.P. Edin., Natalie Nunes, M.B., B.S., M.R.C.O.G., M.D. (Res.), Caroline E. Overton, M.B., B.S., M.D., M.R.C.O.G., F.H.E.A., F.R.C.O.G., Siobhan Quenby, B.Sc., M.B., B.S., M.R.C.O.G., C.C.S.T., M.D., F.R.C.O.G., Sandhya Rao, M.B., B.S., M.D., M.R.C.O.G., Jackie Ross, M.B., B.S., F.R.C.O.G., C.C.S.T., Anupama Shahid, M.B., B.S., D.F.S.R.H., M.R.C.O.G., Martyn Underwood, M.B., Ch.B., M.R.C.O.G., Nirmala Vaithilingam, M.D., Linda Watkins, M.B., Ch.B., M.R.C.O.G., D.F.F.P., Catherine Wykes, M.B., B.S., M.R.C.O.G., M.A., Andrew Horne, M.B., Ch.B., M.R.C.O.G., Ph.D., F.R.C.O.G., and Davor Jurkovic, M.B., B.S., M.D., M.R.C.O.G.
From Tommy’s National Centre for Miscarriage Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham (A.C., A.J.D., V.C., H.H., L.J.M., I.D.G., H.W., A.K.E., T.R., C.C.O.), the Faculty of Medicine and Health Sciences, University of Nottingham (J.P.D.), and Nottingham University Hospitals NHS Trust (S.D.), Nottingham, City Hospitals Sunderland NHS Foundation Trust, Sunderland (A.A., K.H.), the Miscarriage Association, Wakefield (R.B.A.), East Lancashire Hospitals NHS Trust, Burnley (K.B.), Tommy’s Charity (J.B.), Guy’s and St. Thomas’ NHS Foundation Trust (T.H.), King’s College Hospital NHS Foundation Trust (J.J., J.R.), University College London Hospitals NHS Foundation Trust (K.K., D.J.), West Middlesex Hospital, Chelsea and Westminster NHS Foundation Trust (N.N., C.B.), and Barts and the London NHS Trust (A.S.), London, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle (M.C.), Lancashire Teaching Hospitals NHS Foundation Trust, Preston (F.C.), the MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh (W.C.D., J.E.N., A.W.H.), Liverpool Women’s NHS Foundation Trust (L.W.) and St. Helens and Knowsley NHS Trust (S.R.), Liverpool, University Hospitals Coventry and Warwickshire NHS Trust, Coventry (F.I.), the Department of Medicine, University of Glasgow, Glasgow (M.-A.L.), South Tees Hospitals NHS Foundation Trust, Middlesbrough (P.M.), University Hospitals Bristol NHS Foundation Trust, Bristol (C.E.O.), the Biomedical Research Unit in Reproductive Health, University of Warwick, Warwick (S.Q.), Shrewsbury and Telford NHS Trust, Telford (M.U.), Portsmouth Hospitals NHS Trust, Portsmouth (N.V.), and Surrey and Sussex Healthcare NHS Trust, Redhill (C.W.) — all in the United Kingdom; the Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia (I.G.); and the Carver College of Medicine, University of Iowa Health Care, Iowa City (A.E.). Address reprint requests to Dr. Coomarasamy at the Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham Edgbaston, Birmingham B15 2TT, United Kingdom, or at a.coomarasamy@bham.ac.uk.



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