P Janssen, PhD, 1,2,4,5 , MC Klein, MD,CCFP 2,5

1. Outcomes of Five Years of Planned Home Birth Attended by Regulated Midwives vs. Planned Hospital Birth in British Columbia P Janssen, PhD,1,2,4,5 , MC Klein, MD,CCFP2,5 L Saxell, RM, MA3R Liston, MD, FRCSC, FRCOG.4,5 SK Lee, MBBS, PHD, FRCPC, 6 Department of Health Care and Epidemiology1, Family Practice2, Midwifery3 and Obstetrics and Gynecology,4 Faculty of Medicine, University of British Columbia, Child & Family Research Institute5, Vancouver, B.C., ICARE Research Centre, Edmonton, Alberta.6

3. Controversy still exists…. • SOGC • Endorses evidence-based practice and encourages ongoing research into the safe environment of all birth settings. (2003) ACOG • Choosing to deliver a baby at home is to place the process of giving birth over the goal of having a healthy baby.(2008)

4. Study Question Is the decision to plan birth at home with a regulated midwife in attendance compared to the decision to plan birth in hospital attended by a) a physician or b) a regulated midwife associated with adverse perinatal or maternal outcomes? Primary outcome: perinatal mortality

5. Limitations of studies to date

6. Wax Meta-analysis worth some time: • In Wax meta-analysis, only studies meeting criteria for inclusion in analysis of home birth, in that they looked at Planned home birth, are the two Canadian studies and the Dutch study. • All the rest of the included studies should never been part of the meta-analysis. • Questionable if meta-analysis should have been done at all—since interested only in quality studies that could answer the question. All the rest of the included studies only add confusion.

7. Of largest studies included in meta-analysis, only three (Hutton, et al 2009; Janssen et al 2009; & deJonge et al 2009) clearly distinguish between planned and unplanned home births • These three studies—which comprise 93% of the women included in the meta-analysis—found no significant differences in perinatal outcomes or neonatal outcomes. • After publication Canadian Home Birth studies, the College of Physicians and Surgeons of British Columbia rescinded its long held prohibition of physicians attending home births.

8. Of particular note, Wax study is not study at all. A meta-analysis is not a study per se but an amalgamation of studies. “A meta-analysis is only as good as the articles entered into the meta-analysis. • If the quality of the individual included studies is faulty, if the meta-analysis compares apples, oranges, steak and mashed potatoes, the result of the meta-analysis is unappetizing indeed--worse than useless--illustrating the well known principle: garbage in, garbage out.

9. The safety of any birth setting depends mainly on the quality of the system supporting that setting. • Many of the studies utilized by Wax were out of date and more than 20 percent of the births in the Wax meta-analysis were recorded as having no midwife or physician present, and many were not planned for home birth  • Moreover, Wax’s calculation of neonatal mortality risk was flawed, by exclusion of the large Dutch study from one of his calculations. • With more births than all other studies combined, the Dutch study of 321,307 births dominated the meta-analysis.

10. Inclusion of Dutch data in the calculation of perinatal mortality yielded no difference in birth at home or in hospital, but for inexplicable reasons, Wax excluded the Dutch data from his calculation of neonatal mortality, falsely leading to the reported 3 x increase difference in neonatal mortality reported. • Study contributing most newborn deaths, the Pang Washington study could not distinguish planned from unplanned births. • This inappropriately included study, which alone provides more than 1/2 of the neonatal deaths but only just 1/3 of the births, suffers from a number of serious flaws, and has been thoroughly critiqued and long ago dismissed at deeply flawed.

11. Also troubling is that one large study of home birth was excluded by Wax for no apparent reason, notably the only large US study of Certified Professional Midwives published in 2005 in the BMJ, which showed no difference for home vs hospital birth • Serious calculation errors: Statisticians and epidemiologists and many obstetricians heading departments in the US and Canada have tried to replicate Wax’s results and have been unable to do so due to many numerical and statistical errors. • Journal has refused to retract paper. Lancet, BMJ and Nature all have called for a re-evaluation or retraction but Am J has refused, citing that its un-named experts reviewed the paper and stand by the results

12. Large Cohort Studies of Planned Home vs Hospital Incomplete Ascertainment

13. Midwifery in CanadaDirect-entry, autonomous, mostly office or health centre-based • BC Regulated and funded, 4 year baccalaureate program • Alberta – similar • Saskatchewan –Regulated and funded • Manitoba – Regulated and funded • Ontario – Regulated and funded, 4 year baccalaureate program • Quebec – Regulated and funded for birth centres, recently for home and limited hospital--baccalaureate program • New Brunswick – Regulated and funded • Nova Scotia,, PEI, Nfld, Nunavit, Yukon – not regulated • Northwest Territories – in process

14. Funding Models • Ontario, BC, Alberta—entrepreneurial small business • All the rest—salary • Work for Health Authorities

15. Eligibility Requirements for Home Birth in BC • Exclusions • Gestational age > 41 or < 37 weeks • Multiple birth • Breech or other abnormal presentations • Cardiac disease • Hypertensive chronic renal disease • PIH with proteinuria >30 mg/dl • Insulin-dependent diabetes • Antepartum hemorrhage after 20 weeks • Active genital herpes • More than 1 previous C/S

16. Home Birth Study Group • Inclusion • Birth took place at home or in hospital and midwife listed as the caregiver at any time —even after transfer • But for planned home cohort, birth had to meet eligibility criteria at the start of labour at home

17. Transfer Rates from Home 12.8% Multips Nullips 38.1% Overall: 23.6%

18. Methods

19. Study Group for Comparison of Birth Outcomes • Primary Study Group n = 2899 • All births planned (at the onset of labour) to be at home and attended by a regulated midwife eg • Complete Ascertainment • Comparison Groups • 1. Physician-attended births in hospital n = 5331 • 2. Midwife-attended births planned (at the onset of labour) to be in hospital n = 4752 (same midwives)

20. Physician Hospital Comparison Group • Inclusion: • Delivered by a physician in a hospital in which midwives were practicing • Midwife not listed as any kind of caregiver in hospital record • Met eligibility requirements for home births • Matching (2:1) • Year of Birth: 2000-2004 • Parity (nulliparous vs. multiparous) • Hospital where midwife caring for study subject has privileges • Lone parent (yes, no) • Age (< 15 yrs, 15-19, 20-24, 25-29, 30-34, 35+)

21. Midwife Hospital Comparison Group • Inclusion (all midwife-attended planned hospital births) • Gave birth in 2000-2004 • Met eligibility requirements for home birth • Midwife listed as any type of caregiver in hospital record • College of Midwife records indicate birth was planned in hospital

25. Results

26. Socio-Demographic Characteristics - Age

27. Socio-Demographic Characteristics – Median Family Income Quintile per Postal Code

28. Socio-Demographic and Pregnancy Characteristics

29. Use of Substances

30. Other Pregnancy Characteristics Midwifery clients seen earlier and more often!

31. Interventions in Labour by Intention to Treat

32. Method/Mode of Delivery

33. Indication for Cesarean Section

34. Maternal Outcomes 1 1 1

35. Maternal Outcomes

36. Maternal Outcomes 9 6 2 2 1 1 2

37. Maternal Outcomes

38. Maternal Outcomes by Intention * Adjusted for parity Statistically Significant

39. Stillbirth or Neonatal Death/1000 Births

40. Neonatal Outcomes In newborns without major congenital anomalies

41. Neonatal Resuscitation

42. Birth Trauma

43. Neonatal Outcomes Mostly Jaundice

44. Neonatal Outcomes Statistically Significant

45. Comment, Conclusions

46. Not a Randomized Controlled Trial Strength or Limitation?

47. Conclusions Compared to women who planned birth in hospital with a physician, women who planned birth at home with a regulated midwife were: • Less likely to have interventions during labour • Less likely to have adverse maternal outcomes: • 3rd/4th degree tear • Postpartum hemorrhage • Infection or pyrexia • Less likely to have newborns with: • Apgar scores less than 7 at one minute • Birth trauma • Resuscitation at birth • Birthweight < 2500 g at term • Requirement for oxygen therapy more than 24 hours

48. Conclusions Compared to women who planned birth in hospital with a regulated midwife, women who planned birth at home with a regulated midwife were: • Less likely to have interventions during labour • Less likely to have adverse maternal outcomes: • 3rd/4th degree tear • Postpartum hemorrhage • Pyrexia • Less likely to have newborns with: • Apgar scores less than 7 at one minute • Meconium aspiration • Birth trauma • Resuscitation at birth • Requirement for oxygen therapy more than 24 hours • More likely to have a newborn: • Admitted to hospital

49. CaveatHome birth is neither safe or unsafe • Hospital birth is neither safe or unsafe • Either can be safe or unsafe • DEPENDS!! • In BC home birth by regulated supported midwives appears to be safe • Quebec Maison de Naissance (Birth Centres)?? • Safety depends on cooperation and support and collegiality

50. In most respects, the procedures and outcomes of hospital births attended by regulated midwives are more similar to hospital births attended by physicians than they are to home births attended by the same midwives