Medico-legal Perspectives on the Reintroduction of Vaginal Breech Births
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Professor Alec Welsh, Professor, UNSW & Chair of Maternal Fetal Medicine, from the Royal Hospital for Women has presented at the Obstetric Malpractice Conference. If you would like more information ...

Professor Alec Welsh, Professor, UNSW & Chair of Maternal Fetal Medicine, from the Royal Hospital for Women has presented at the Obstetric Malpractice Conference. If you would like more information about the conference, please visit the website: http://bit.ly/10xh1iO

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Medico-legal Perspectives on the Reintroduction of Vaginal Breech Births Presentation Transcript

  • 1. Medico-Legal Issues andBreech BirthSchool of Women’s & Children’s Health
  • 2. Professor Alec WelshMBBS MSc PhD FRCOG(MFM) FRANZCOG DDU CMFMProfessor in Maternal-Fetal MedicineSchool of Women‟s & Children‟s HealthUniversity of New South WalesRandwick, SydneyHead of DepartmentMaternal-Fetal MedicineRoyal Hospital for WomenRandwick, SydneyDirectorAustralian Centre for Perinatal ScienceUniversity of New South WalesRandwick, Sydney
  • 3. The Term BreechTrialalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 4. Why the TBT was needed Until the late 1950s Vaginal Birth (VB) was mode ofchoice Wright 1959; Trolle D 1960: 3-4x increase in perinatalmortality cf CS Balanced by CS risks By 1980s CS rate about 80% No conclusive evidence: 2 RCTs in early 80‟s Increased fetal risk with VD Small numbers and still maternal risk Small retrospective studies contradictoryalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 5. Why the TBT was needed 1979 Archie Cochrane awarded obstetrics the„wooden spoon‟ for least evidence basedmedical specialty RCT became the answer to medical questions,no matter how complex Medicolegal anxiety esp in USA provoked ajustification for CS, reducing medicolegal riskalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 6. The TBTLancet 2000 Oct 21Hannah et alalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 7. Construction of the TBT Singleton live fetus in a frank or complete breech atterm (≥37 weeks) Exclusion if >4kg; hyperextension; fetal anomaly;contraindication such as placenta praevia 2083 women across 121 centres in 26 countries withvaried perinatal mortality rates Vaginal breech birth performed by „experiencedclinicians‟ as judged by self and supervisoralec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 8. Construction of the TBT Primary outcomes: perinatal mortality; neonatalmortality; or one of a number of measures ofserious morbidity Secondary outcomes: Maternal mortality or seriousmorbidity during first 6 weeks postpartum Sample size calculated as 2800 with an 80%power to find a reduction in risk of perinatal orneonatal mortality or serious morbidity from 0.8%with VB to 0.1% with CS Second interim analysis at 1600 recommendedceasing; another 488 meanwhile recruited => 2088alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 9. Results of the TBT 2088 women: entry and outcome data for99.8% women Planned CS – 90.4% delivered by CS Planned VB – 56.7% delivered vaginally 6 of 16 deaths associated with difficult vaginaldelivery 4 deaths associated with FHR abnormalities inlabouralec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 10. Results of the TBT Perinatal mortality, neonatal mortality or seriousneonatal morbidity significantly lower forplanned CS vs VB (1.6% vs 5.0%) Relative Risk 0.33 (95% CI 0.19-0.560 p<0.0001. No differences for maternal mortality or seriousmaternal morbidity (3.9% vs 3.2%). RR 1.24 (0.79-1.95) p=0.35.alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 11. Results of the TBT After removing confounders still lower risk ofcomplications with CS Policy of planned CS meant for every additional14 CS performed one baby will avoid death orserious morbidityalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 12. The Impact of theTBTalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 13. Unprecedented impact Professional obstetrical associations worldwidereleased guidelines and opinion statementsrecommending a policy of routine CS for breech(e.g. ACOG/RCOG) Denmark: CS increased from 79.6% to 94.2% Netherlands: over 2 months CS rate increased from50% to 80% Canadian survey: VB offer dropped from 84% to 14% By 2003 >92.5% of TBT centres had completelyabandoned VBalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 14. Rietberg et al. BJOG 2005alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 15. The Australian Context Muted acceptance of the TBT conclusions: planned fordiscussion at a breakfast meeting at PSANZ – no discussion The „Medical Indemnity Crisis‟ of 2000-201: NSW Supreme Court: Simpson $11M payout for obstetricnegligence (cerebral palsy following failed forceps and CS) Collapse of UMP: providing indemnity for 90% NSW doctors Indemnity Summit – Policy Support Scheme – if >7.5% of grossincome..... MacLennan & Spencer MJA 2002: Projections of Australianobstetricians ceasing practice and the reasons Obstetric trainee recruitment decline from 2000-2010alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 16. Impact within Australia Between 1991 and 2005 VB of singleton breech fetusesin Australia dropped from 23.1% to 3.7%. NSW, 66% decline in VB for breech with steepestdecline 2000-2001: corresponded to a halving of thebreech PNMR 6.2 to 3.1/1000. Feb 2001: RANZCOG statementthat VB of the breech fetus carrieshigher risk than PCS.Phipps et al. JANZCOG 2003alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 17. Workforce issues of the TBT Dramatic reduction in training for juniorobstetricians in vaginal breech birth Significant issues in 2 situations: Client refusal to consent for caesarean section Arrival to hospital too late for safe CS (breech „on-view‟) Lost skills results in unnecessary fetal andmaternal mortality and morbidityalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 18. 2 year follow uppapers from theTBTalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 19. Maternal and child outcomes at 2 years:AmJOG 2004alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 20. Outcomes of children at 2 years 923 of 1159 children (79.6%) from 85 centres followed to 2years Risk of death or neurodevelopmental delay no different forCS than VB (14(3.1%) vs 13(2.8%); RR1.09 (CI 0.52-2.30) 6% absolute increase in risk of unspecified medicalproblems in children randomised to PCS Conclusion: Planned caesarean section delivery is notassociated with a reduction in risk of death orneurodevelopmental delay in children at 2 years of agealec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 21. Outcomes of mothers at 2 years 917 of 1159 (79.1%) from 85 centres completed a structuredmaternal questionnaire No differences: breast feeding; relationships; pain;pregnancy; incontinence; depression; etc Planned CS associated with a higher risk of constipation Conclusion: Maternal outcomes at 2 years postpartumare similar after planned caesarean section and vaginalbirth for the singleton breech fetus at termalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 22. A call for retractionalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 23. Editorial: John M Grant BJOG “The Term Breech Trial is an example of a randomised trial that wasimpeccable as regards its methodological design, but wasquestionable as regards it clinical design. “More attention ... power calculation, randomization and interimanalysis, and less to clinical outcomes such as reasons forperinatal death and definition of serious neonatal morbidity. “As regards the infant, main concern of vaginal breech delivery istrauma and birth asphyxia...; the main concern of electivecaesarean section is respiratory distress. These should have beenthe primary outcomes of the trial”alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 24. Editorial: John M Grant BJOG “Almost immediately, the conclusions of the trial wereaccepted by the medical community. “Rarely in medical history have the results of a singleresearch project so profoundly and so ubiquitously changedmedical practice as in this publication. “A recent survey (>80 centres in 23 countries) concluded that92.5% of the surveyed centres have completely abandonedplanned vaginal breech delivery in favour of caesareandelivery.”alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 25. What was wrongwith the TBT?alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 26. TBT: A perfect statistical study(in an imperfect clinical world)MulticentreRandomisedControlledTrialIntention to TreatCompoundmorbidityMultioperator in a diverserange of environmentsReducing a complex clinicalissue to a simplerandomisation processStatistically „ideal‟ but relatespoorly to actual managementInability for any singlemorbidity to be significant plusvaried relevance and impactalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 27. The Flaws in TBT: The Deaths 3 deaths in CS group1. 2300g respiratory issues post CS2. 2850g myelomeningocoele ruptured during CS3. 2550g stillborn after attempted difficult vaginal birth 13 deaths in planned VB1. Twin BW 1150g2. 3650g CEPHALIC3. 2000g Late neonatal death: sent home well4. 2500g discharged home well died after d&v5. 2500 and 2700g neonatal deaths: respiratory no issues withbirth6. 3 x FHR abnormalities: 2 loss of FH before CS7. 3370g difficult delivery led to CSOnly 4 deathswhere difficultvaginal birthalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 28. The Flaws in TBT: Serious Neonatal MorbidityIssues of „Compound Morbidity‟: 14 in CS, 39 in VB Hypotonia: 2 CS vs 18 VB. In 7 of 18 disappeared at 2 hours Abnormal level of consciousness in 13 of planned VB Of the 69 cases of composite perinatal morbidity and deathon which all of the conclusions are based, only 16 casescould be related to the mode of delivery. Not statisticallysignificantalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 29. The Flaws in TBT: other issues There is an argument against indiscriminate allocation to VBor CS: case selection During active labour only borderline difference in perinataloutcome in favour of PCS (OR 0.57; 0.32-1.02: p=0.06) Study included 2 sets of twins, 1 anencephaly and 2 stillbirths Fetuses >4000g overrepresented in VB group (5.8% vs 3.1%) Huge variation in standard of care between participatingcentres Many VB didn‟t get skilled accoucher: 18.5% obstetrictrainees; 2.9% student midwife: accounted for 32% of infantswith significant morbidity More than half the data from countries with PNMR >20/1000alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 30. Glezerman: AmJOG Opinion 2006:5 years to the term breech trial: The rise and fall of arandomised controlled trial “Repeated analysis of the data after 2 years, reveals that the initialconclusions can no longer be maintained and that actually therewas no difference in outcome between the 2 groups. This was truefor both neonates and mothers. Yet, until now, the authors continue,in all subsequent publications, to reiterate their original conclusions.. “A comprehensive and unequivocal withdrawal of the TBTconclusions by the authors themselves is overdue. “Most probably the point of no return has been reached as far asplanned vaginal breech delivery is concerned, despite the fact thatevidence is still lacking.”alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 31. Evidence since theTBT papersalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 32. De Leeuw. The end of vaginal breech delivery.BJOG 2007 (letter) Impact of TBT in the Netherlands (2001-2005): 327 planned CS needed to save one extra child and evenmore child deaths due to cases of uterine rupture, praevia andincreased SB rate before term with previous CS 4 maternal deaths as a result of elective CS for breech Uterine scars and future accreta Future pregnancies 4 children with brain damage from uterinerupture 35 million Euros spent on 7500 extra CS Netherlands: 2154 children born after PVB: 98.1% alive andwell cf 99.8% elCS and 99.3% emCS Should 997 out of 1000 women have a superfluous CS to savethe life of 3 babies?alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 33. Other issues Issues with standard of care in the TBT means thatadverse outcomes are not surprising Randomisation homogenises a heterogeneouspopulation with varying risk profiles. Subsequent results not reflective or applicable to wellselected, low risk groups in experienced centres. A number of obstetric units with tradition of vaginalbreech birth conducted retrospective audits and nationalpopulation studies. Most of these found no significant difference in severemorbidity and perinatal / neonatal mortality with a lowoverall incidence of adverse outcome compared to theTBTalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 34. The Premoda Study.Goffinet et al. AmJOG 2006 Observational: all term singleton breeches in Franceand Belgium over one year 2529 PVB; 5576 PCS TBT comparable composite variable Low rate of overall adverse outcome (1.59% vs 3.22%in TBT) with no sig difference between groups. Why? Unbroken tradition of VB in France & Belgium Better selection of candidates Higher standard of care More stringent management guidelinesalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 35. Where are we nowmedicolegally?alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 36. College Statements RANZCOG statement on vaginal breech 2009: now revisedto allow the existence of subgroups with the potential forsuccessful VB, advising management to be individualised SOGC Guideline 2009: Careful case selection and labourmanagement in a modern obstetrical setting may achieve alevel of safety similar to elective Caesarean section. Plannedvaginal delivery is reasonable in selected women with a termsingleton breech fetus.alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 37. Current practice:‘Judgement by practice of peers’ Most obstetricians do not wish to provideplanned Vaginal Birth for Breech Presentation 2 major reasons: Lack of current experience Medico-legal fearalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 38. What is the current legal opinion?American Legal Firm Website June 2012: “For breech births, a compressed cord means the infantcannot get enough oxygen because the head remains inthe birth canal. “If the doctor fails to identify a breech position before laboroccurs, many complications can occur. “The baby must be delivered quickly to avoid brain damagefrom a potentially compressed cord that may cut off thechild‟s supply of blood and oxygen. “A vaginal breech delivery can be dangerously delayed ifthe infants head catches inside the motheralec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 39. Report of a maternal death in a breech birth:Lawson. Birth 2011 Around the time of TBT: Burke:“caesareans...nowadays costnothing in terms of maternalmortality, morbidity oreconomically” De Leeuw and Schutte: papersfrom Holland noted 4 deathsassociated with elective breechcaesarean section between 2000and 2002alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 40. ‘Safe’reintroduction ofVaginal BreechBirthalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 41. The things that the TBT didn’t teach us What is the role of planned, worked up vaginalbreech delivery in a developed country with fastaccess to emergency CS if needed? How can we reinstate VB in Australia to achieve thehigh standards prescribed by the PREMODA groupas well as training obstetricians to be confident andcompetent? in face of: Low volume of births Large distances between „breech‟ units Potential resource implications Graduating trainees: 47% don‟t feel confident and 89%don‟t plan to offer it as specialists Chinnock 2007alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 42. Lawson et al. Birth March 2012 From 2002 onwards papershave attacked the TBT but themajority of the obstetricworkforce have ignored them... Further deconstruction ofthe TBT: Clinical guidelines at odds withstandard obstetric practice Numerous VBACs Criteria for “usual” standard ofcare very suspect – wouldgenerally rate as “substandard”by most definitionsalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 43. The John Hunterexperiencealec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 44. John Hunter Hospital (Newcastle, NSW) Large metropolitan hospital that continued to selectivelyoffer VB for singleton breech presentation Stringent criteria throughout regarding: selection;management of labour and delivery Approximately 400 breech births including manyinterstate clients due to lack of accommodation withinthe public sector in the majority of public hospitals. Current audit underway to evaluate maternal andneonatal outcomes of this service between January1999 and August 2010 in comparison to the internationalpublished literature.alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 45. Royal Hospital for Women, Sydney Vaginal Breech service introduced – too early for audit Widespread acceptance amongst consumers andmidwives, mixed response from obstetricians Vaginal Breech Birth now offered or underconsideration: John Hunter Hospital Royal Hospital for Women Westmead Royal Prince Alfred (informal)alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 46. Breech Counseling @ theRoyal Hospital for Womenalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 47. Further Opinion: Most recent O&G MagazineDr Henry Murray FRANZCOG CMFMalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 48. Breech Conference at the Royal Hospital forWomen late 2012 International Expert: Frank Louwen from Frankfurt Presentation from Dr Bisits of the JHH Breech Audit Open invitation: in particular legal attendance welcome However there will be no specific “medico-legal”sessions: the starting point of this meeting is thatselected vaginal breech is safe, evidence based and notin need of special medico-legal consideration.alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 49. Conclusions There was never convincing evidence to abandonvaginal breech birth Vaginal breech birth is safe for appropriately selectedcases (and those selected out are relatively few) Our greatest danger is now having an insufficientlytrained workforce Women are being forced to travel interstate or pay forprivate obstetric care to achieve a vaginal breech birthalec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)
  • 50. Any questions?Lawson. The Term Breech Trial Ten Years On: Primum Non Nocere? Birth 39:1 March2012Lawson. Report of a Breech Cesarean Section Maternal Death. Birth 38:2 June 2011Goffinet et al for the PREMODA Study Group. Is planned vaginal delivery for breechpresentation at term still an option? AmJOG 2006:194: 1002-11Van Roosmalen. Commentary. There is still room for disagreement about vaginal deliveryof breech infants at termGlezerman. Five years to the term breech trial: The rise and fall of a randomizedcontrolled trial. AmJOG 2006; 194: 20-5Keirse. Evidence-Based Childbirth Only for Breech Babies. Birth 29:1 March 2002.Burke. The end of vaginal breech delivery. BJOG 2006; 113:969-972Rietberg. The effect of the Term Breech Trial on medical intervention behaviour andneonatal outcome in the Netherlands: an analysis of 35,453 term breech infants.BJOG 2005; 112:205-209Hannah et al. Planned caesarean section versus planned vaginal birth for breechpresentation at term: a randomised multicentre trial. Lancet 2000; 356:1375-83Whyte et al. Outcomes at 2 years after .....AmJOG 2004; 191:864-71Hannah et al. Maternal outcomes.....AmJOG 2004; 191: 917-927References:alec.welsh@unsw.edu.auMedico-Legal Issues and the current state of vaginal breech birth:4th Annual Obstetric Malpractice Conference (21-22 June 2012)