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For Peer Review Only Journal: BMJ Open BMJ Open A nationwide population -based cohort study of peripartum hysterectomy and arterial embolisation in Belgium: results from the Belgian Obstetric Surveillance System. For peer review only Journal: BMJ Open Manuscript ID bmjopen-2017-016208 Article Type: Research Date Submitted by the Author: 14-Mar-2017 Complete List of Authors: Vandenberghe, Griet; Ghent University Hospital, Department of Obstetrics and Gynaecology Guisset, Marine; Leuven University Hospital, Department of Obstetrics and Gynaecology Janssens, Iris; Ghent University, Faculty of Medicine Van Leeuw, Virginie; Perinatal Epidemiology Centre (Centre d'Épidémiologie Périnatale, CEpiP); School of Public Health, Université Libre de Bruxelles (ULB) Roelens, Kristien; Ghent University Hospital, Department of Obstetrics and Gynaecology Hanssens, Myriam; University Hospital Leuven, Department of Obstetrics & Gynaecology Russo, Erika; Intercommunale de Santé Publique du Pays de Charleroi (ISSPC), Department of Obstetrics and Gynaecology Vankeirsbilck, Joachim; St Jan's Hospital, Department of Obstetrics and Gynaecology Englert, Yvon; Perinatal Epidemiology Center (Centre d'Épidémiologie Périnatale, CEpiP); Université Libre de Bruxelles, Faculty of Medicine, Research Laboratory on Human Reproduction Verstraelen, Hans; Ghent University Hospital, Department of Obstetrics and Gynaecology <b>Primary Subject Obstetrics and gynaecology Heading</b>: Secondary Subject Heading: Epidemiology peripartum hysterectomy, arterial embolisation, Interventional radiology < Keywords: RADIOLOGY & IMAGING, maternal near miss, severe maternal morbidity For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 37 BMJ Open 1 2 3 1 TITLE PAGE 4 5 2 Title of the article: 6 7 3 A nationwide population-based cohort study of peripartum hysterectomy and arterial embolisation in 8 9 4 Belgium: results from the Belgian Obstetric Surveillance System. 10 5 11 12 6 Author and Co-Author’s name: 13 14 7 Vandenberghe G, Guisset M, Janssens I, Van Leeuw V, Roelens K, Hanssens M, Russo E, Van Keirsbilck J, 15 For peer review only 16 8 Englert Y, Verstraelen H. 17 9 18 19 10 Corresponding author: Griet Vandenberghe 20 21 11 Department of Obstetrics & Gynaecology 22 12 Ghent University Hospital 23 24 13 De Pintelaan 185, 9000 Ghent, Belgium 25 26 14 E-mail: [email protected] 27 28 15 Telephone number: +32 9 33 27 849 29 16 30 31 17 Co-author: Marine Guisset 32 33 18 Department of Obstetrics & Gynaecology 34 35 19 Leuven University Hospital 36 20 Leuven, Belgium 37 38 21 E-mail: [email protected] 39 40 22 41 23 Co-author: Iris Janssens 42 43 24 Faculty of Medicine 44 45 25 Ghent University 46 47 26 Ghent, Belgium 48 27 E-mail: [email protected] 49 50 28 51 52 29 Co-author: Virginie Van Leeuw 53 54 30 Perinatal Epidemiology Center (Centre d’Épidémiologie Périnatale, CEpiP) 55 31 School of Public Health, Université Libre de Bruxelles (ULB), Brussels, Belgium 56 57 32 Brussels, Belgium 58 59 33 E-mail: [email protected] 60 34 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 37 1 2 3 35 Co-author: Kristien Roelens 4 36 Department of Obstetrics & Gynaecology 5 6 37 Ghent University Hospital 7 8 38 Ghent, Belgium 9 10 39 E-mail: [email protected] 11 40 12 13 41 Co-author: Myriam Hanssens 14 15 42 Department Forof Obstetrics peer & Gynaecology review only 16 43 University Hospital Leuven 17 18 44 Leuven, Belgium 19 20 45 E-mail: [email protected] 21 22 46 23 47 Co-author: Erika Russo 24 25 48 Department of Obstetrics & Gynaecology 26 27 49 Intercommunale de Santé Publique du Pays de Charleroi (ISPPC) 28 29 50 Hôpital Civil Marie Curie 30 51 Charleroi, Belgium 31 32 52 E-mail: [email protected] 33 34 53 35 54 Co-author: Joachim Vankeirsbilck 36 37 55 Department of Obstetrics & Gynaecology 38 39 56 St Jan’s Hospital 40 41 57 Bruges, Belgium 42 58 E-mail: [email protected] 43 44 59 45 46 60 Co-author: Yvon Englert 47 48 61 Perinatal Epidemiology Center (Centre d’Épidémiologie Périnatale, CEpiP) 49 62 Research Laboratory on Human Reproduction, Faculty of Medicine, Université Libre de Bruxelles (ULB) 50 51 63 Brussels, Belgium 52 53 64 E-mail: [email protected] 54 65 55 56 66 Co-author: Hans Verstraelen 57 58 67 Department of Obstetrics & Gynaecology 59 60 68 Ghent University Hospital 69 Ghent, BelgiumFor peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 37 BMJ Open 1 2 3 70 E-mail: [email protected] 4 71 5 6 72 Keywords: peripartum hysterectomy, arterial embolisation, interventional radiology, major obstetric 7 8 73 haemorrhage, maternal near miss, severe maternal morbidity 9 10 74 11 75 Word count: The main text consists of 5952 words 12 13 76 14 15 77 Background:For peer514 words review only 16 78 Methods: 1007 words 17 18 79 Results: 2630 words 19 20 80 Discussion: 1670 words 21 22 81 Conclusion: 131 words 23 24 82 Total: 5952 words 25 83 26 27 84 Tables and Figures: The manuscript includes 4 tables and 4 figures. Figures are uploaded, in TIFF 28 29 85 format with a resolution of 300 DPI, separately from the text. 30 86 31 32 87 33 34 88 35 36 89 37 90 38 39 91 40 41 92 42 93 43 44 94 45 46 95 47 48 96 49 97 50 51 98 52 53 99 54 55 100 56 101 57 58 102 59 60 103 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 37 1 2 3 104 ABSTRACT 4 5 105 Objectives: 6 7 106 To assess the prevalence of major obstetric haemorrhage managed with peripartum hysterectomy and/or 8 9 107 interventional radiology (IR) in Belgium. To describe women characteristics, circumstances in which the 10 108 interventions took place, management of the obstetric haemorrhage, outcome and additional morbidity of 11 12 109 these women. 13 14 110 Design: 15 For peer review only 16 111 Nationwide population-based prospective cohort study. 17 112 Setting: 18 19 113 Emergency obstetric care. Participation of 97% of maternities covering 98.6% of the deliveries in Belgium. 20 21 114 Participants: 22 115 All women who underwent peripartum hysterectomy and/or IR procedures in Belgium between January 2012 23 24 116 and December 2013. 25 26 117 Results: 27 28 118 We obtained data on 166 women who underwent peripartum hysterectomy (n=84) and/or IR procedures 29 119 (n=102) to manage or prevent major obstetric haemorrhage. One in 3030 women who gave birth in Belgium 30 31 120 underwent a peripartum hysterectomy, while another 1 in 3030 women was managed by IR thereby preserving 32 33 121 the uterus. Interventional radiology procedures were able to cease the bleeding in 87.8% of the attempts. 34 35 122 Abnormal placentation and/or uterine atony were the reported causes of haemorrhage in 83.7%. Abnormally 36 123 invasive placenta was not detected antenatally in 34% of cases. The interventions were planned in 15 women. 37 38 124 Three women were transferred antenatally and seventeen women postnatally to a hospital with emergency IR 39 40 125 service. Urgent peripartum hysterectomy could be averted in 72% of women who were transferred, with no 41 126 significant difference in need for transfusion. Disseminated intravascular coagulation secondary to major 42 43 127 haemorrhage was reported in 32 women. One woman died, the case fatality rate was 0.6% (95% CI 0.1-3.3). 44 45 128 Conclusion: 46 47 129 The prevalence in Belgium of major obstetric haemorrhage requiring peripartum hysterectomy and/or IR is 48 130 estimated at 6.6 (95% CI 5.7-7.7) per 10 000 deliveries. Implementing routine screening for abnormal 49 50 131 placentation could further improve management and outcome of major obstetric haemorrhage. A case-by-case 51 52 132 in-depth analysis would be necessary to reveal whether the hysterectomies performed in this series were 53 54 133 appropriate or preventable. 55 134 56 57 58 135 59 60 136 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 37 BMJ Open 1 2 3 137 ARTICLE SUMMARY: Strengths and limitations of this study: 4 5 138 6 139 • This is a nation-wide study of Belgian maternities, with excellent participation and response rates 7 8 9 140 (98.8%). 10 11 141 • The cases were collected on a monthly basis using the standard methodology of the Obstetric 12 13 142 Surveillance Systems. 14 15 For peer review only 16 143 • Data from the background population as control group were limited to those available in the Belgian 17 18 144 perinatal registry. 19 20 145 • This series describes how women with major obstetric haemorrhage were managed with peripartum 21 22 23 146 hysterectomy and/or interventional radiology according to the circumstances of the event, but does 24 25 147 not allow to making firm conclusions on the motivation or the appropriateness of this management. 26 27 148 28 29 149 30 31 150 BACKGROUND 32 33 151 Emergency peripartum hysterectomy has been referred to as the single most dramatic procedure in modern 34 35 152 obstetrics and has been listed by the World Health Organisation (WHO) as an identification criterion for 36 37 38 153 maternal near miss.(1) The near miss concept has been introduced in the face of very low maternal mortality 39 40 154 rates in developed country settings (2) and has been increasingly adopted as an indicator of obstetric care and 41 42 155 as an analytic tool to address health system failures with the overall goal of improving obstetric care.(3) 43 44 45 156 Substandard care in the management of major obstetric haemorrhage continues to be a critical cause of 46 47 157 maternal deaths and severe maternal morbidity in developed countries.(4, 5) Internationally recognized 48 49 158 guidelines (6-8) generally recommend that all obstetric practitioners should be trained in the management of 50 51 52 159 postpartum haemorrhage, to guarantee an immediate response and a multidisciplinary team approach.
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