FACULTY OF HEALTH AND MEDICAL SCIENCES UNIVERSITY OF COPENHAGEN ! Neonatal complications after vacuum extraction ! ! ! PhD!thesis! Mathilde!Maagaard,!MD! ! ! ! Author Mathilde Maagaard, MD Juliane Marie Centre for Children, Women and Reproduction Rigshospitalet, Copenhagen University Hospital, Denmark E-mail: [email protected] Academic advisors Bent Ottesen, MD, professor, DMSc, managing director, Juliane Marie Centre for Children, Women and Reproduction, Rigshospitalet, Copenhagen University Hospital, Denmark Jette Led Sørensen, MD, associate professor, MMEd, head of education, Juliane Marie Centre for Children, Women and Reproduction, Rigshospitalet, Copenhagen University Hospital, Denmark Jens Langhoff-Roos, MD, DMSc, Department of Obstetrics and Gynecology, Juliane Marie Centre, Rigshospitalet, Copenhagen University Hospital, Denmark Assessment committee Lone Krebs, MD, associate professor, DMSc, Department of Obstetrics and Gynecology, Holbæk Hospital, Denmark Pål Øian, MD, professor, DMSc, University of Tromsø, Norway Berit Eika, MD, professor, PhD, MHPH, vice-associate dean of education, Aarhus University, Denmark Submitted: 15.10.2013 PhD defense: 24.01.2014 Table of contents PREFACE ........................................................................................................................................... 4! PAPERS .............................................................................................................................................. 5! ABSTRACT ........................................................................................................................................ 6! SUMMARY ........................................................................................................................................ 8! RESUME ........................................................................................................................................... 10! ABBREVIATIONS .......................................................................................................................... 12! INTRODUCTION ............................................................................................................................ 13! OBJECTIVES .................................................................................................................................. 14! BACKGROUND .............................................................................................................................. 15! The vacuum extractor ...................................................................................................................... 15! Neonatal complications .................................................................................................................... 16! Techniques and skills ....................................................................................................................... 18! Training ............................................................................................................................................. 20! METHODS AND MATERIALS .................................................................................................... 26! Study I: Vacuum extraction at term and neonatal complications ............................................... 26! Study II: Vacuum extraction: Assessment of the PROMPT birthing simulator ....................... 26! Study III: Vacuum extraction: Development and testing of a procedure-specific rating scale 28! RESULTS ......................................................................................................................................... 29! Study I: Vacuum extraction at term and neonatal complications ............................................... 29! Study II: Vacuum extraction: Assessment of the PROMPT birthing simulator ....................... 30! Study III: Vacuum extraction: Development and testing of a procedure-specific rating scale 31! 2 DISCUSSION ................................................................................................................................... 34! Perspectives and Future Studies ..................................................................................................... 41! CONCLUSION ................................................................................................................................. 41! ACKNOWLEDGEMENTS ............................................................................................................. 42! FUNDING AND DISCLOSURES .................................................................................................. 44! REFERENCES ................................................................................................................................. 45! APPENDIX A ................................................................................................................................... 55! APPENDIX B ................................................................................................................................... 61! APPENDIX C ................................................................................................................................... 65! APPENDIX D ................................................................................................................................... 66! 3 Preface This PhD thesis was conducted between 2008 and 2013 during my employment as a PhD fellow at Juliane Marie Centre for Children, Women and Reproduction, Rigshospitalet, Copenhagen University Hospital. For further information or questions, please contact: Mathilde Maagaard, MD Rigshospitalet, Copenhagen University Hospital Juliane Marie Centre for Children, Women and Reproduction Blegdamsvej 9 Copenhagen 2100 Denmark E-mail: [email protected] 4 Papers This thesis is based on the following three papers: I. Vacuum extraction at term and neonatal complications Maagaard M, Bjerager M, Rosthøj S, Rusch E, Sorensen JL, Ottesen B, Langhoff-Roos J. Submitted, September 2013. II. Vacuum extraction: Assessment of the PROMPT birthing simulator Maagaard M, Strandbygaard J, Larsen CR, Johansen M, Andersen LL, Ringsted C, Ottesen B, Sørensen JL. Submitted, June 2013. III. Vacuum extraction: Development and test of a procedure-specific rating scale Maagaard M, Oestergaard J, Johansen M, Andersen LL, Ringsted C, Ottesen B, Sørensen JL. Acta Obstetricia et Gynecologica Scandinavica 2012 Dec;91(12):1453–9. 5 Abstract ! Background In Denmark, 8–10 percent of all newborn babies are delivered by vacuum extractor. When vacuum extraction was introduced 60 years ago, the method was regarded as ‘easy and safe’. In recent years, however, the Food and Drug Administration in the United States and authorities in other countries have brought attention to reports of increasing neonatal morbidity and mortality associated with vacuum extraction. We decided to investigate whether this association between vacuum extraction and neonatal morbidity can be found in a large Danish cohort. A high rate of morbidity might reflect the indication for the vacuum extraction or inadequate training of doctors. The transition from time-based to competence-based specialist training requires structured training programs and assessment methods for vacuum extraction. Therefore, we validated a birthing simulator to be used as a training tool and for assessing skills performance. Finally, we developed a procedure-specific assessment scale for assessing doctors’ skills when performing vacuum extraction. Objectives Study 1: o To study the risk of neonatal complications after vacuum extraction compared with spontaneous vaginal delivery and emergency cesarean section in labor in Denmark. o To study the influence of parity and level of application of the vacuum extractor on neonatal complications in Denmark. o To study trends in mode of delivery and neonatal complications in Denmark between 2002 and 2010. Study 2: o To validate the PRactical Obstetric Multi-Professional Training (PROMPT) birthing simulator1 for use as a training tool and for assessing skills performance in a simulated scenario of vacuum extraction. Study 3: o To develop and validate a procedure-specific assessment scale for vacuum extraction. Design Study 1: o A register-based cohort study between January 1, 2002 and December 31, 2010 of term, singleton, and cephalic live-born neonates based on the Danish National Medical Birth Registry, the National Patient Registry and the Danish Register of Causes of Death on term. Study 2: o A prospective study to validate the PROMPT birthing simulator in two groups of doctors, residents and senior physicians. Study 3: o A prospective bipartite study of: (a) the development of a procedure-specific checklist using a modified Delphi method and (b) the validation and development of an objective structured assessment of technical skills (OSATS) scale for vacuum extraction. 6 Results Study 1: o The risk of neonatal complications was higher after vacuum extraction than after spontaneous vaginal delivery. The risks increased from low to high application of the vacuum extractor and were highest after failed (unsuccessful) extraction, especially in multipara. The odds ratios (OR) were 1.8 [1.1–2.9] for neonatal death after vacuum extraction, 1.29 [0.7–2.4] after low-level application, 3.4 [1.7–7.0] after high-level application, and 1.8 [1.0–3.3] after emergency cesarean section in labor compared with spontaneous delivery. The