1. Indicated Labor Induction Phase One: Protocol Development Peter Cherouny, M.D. University of Vermont Department of OB/GYN

2. Indicated Labor Induction Phase One: Protocol Development Objectives –After the presentation the participant will be able to: –Articulate the risks of proposed obstetric care to the patient –Incorporate the risks of care into patient care discussions –Recognize the absolute level of risk of fetal death at term

3. Indicated Labor Induction Phase One: Protocol Development To Induce or not to Induce Setting the Stage

4. The Cost of Oxytocin

5. The Real Cost of Oxytocin The costs to the patient from coming to us for care: Safety Risk and Cost

6. Focus on the group with the highest variability for Primary Cesarean delivery (by provider or institution) Term IUP Cephalic presentation No contraindications for labor/vaginal delivery

7. Focus on the group with the highest variability for Primary Cesarean delivery (by provider or institution) First term pregnancies (without prior labor) Multiparous term with a prior vaginal delivery The Intention is to treat these women with vaginal delivery How many patients are there?

8. Focus on the group with the highest variability for Primary Cesarean delivery (by provider or institution) How many of our patients? –70% deliver vaginally70% –70% primary cesarean sections21% have indications that did not 91% preclude labor Failure to induce, dilate or descend elective cesarean

9. Focus on the group with the highest variability for Primary Cesarean delivery (by provider or institution) Remember The Intention is to treat these women with vaginal delivery

10. Our 91%er

11. Because we have pitocin, we… (Term IUP, cephalic presentation, no labor) Induce labor(25%) -10% elective IOL

12. Because we have pitocin, we… (Term IUP, cephalic presentation, no labor) Augment labor(30%) –Induction vs augmentation What’s your definition

13. By Delivery Type Term IUP, cephalic presentation Spon labor Vaginal Delivery Pitocin labor Vaginal Delivery or C/S Spon Labor Cesarean Section

14. By Labor Type Term IUP, cephalic presentation Spon labor Pitocin Labor Cesarean Section Vaginal Delivery

15. Because we have pitocin, we… Term IUP, cephalic presentation Induce or Augment labor (55-90%) –What’s the patient pitocin exposure in your L&D?

16. Because we have pitocin, we… Term IUP, cephalic presentation, no labor Induce labor(25%) –Increase nursing time 1:2 for active labor –Increase provider time in hospital in active labor –Increase analgesia use 90% with IOL, 100% with OVD

17. Because we have pitocin, we… Term IUP, cephalic presentation, no labor Induce labor(25%) –Increase OVD 2-3 fold Relative Risk –Increase cesarean sections 2-3 fold Relative Risk –Increase general anesthesia 5% of cesarean sections –Increase NICU admissions 2-4 fold RR at Term

18. Because we have pitocin, we… Term IUP, cephalic presentation Induce or Augment labor leading to C/Section –Increase postpartum hemorrhage RR 1.4-2.3 1-6% requiring transfusion –Increase postoperative DVT/PE Common cause of maternal mortality –Increase hospitalization (nosocomial infection, etc.) –Increase AFE (amniotic fluid embolus) –3-4 fold RR after IOL –12 fold RR after Cesarean section

19. Because we have pitocin, we… Term IUP, cephalic presentation Induce or Augment labor leading to C/Section –Increase postpartum/cesarean hysterectomies 3 fold RR of placenta previa after 1 cesarean section 45 fold RR after 4 or more prior Cesarean deliveries 5 fold RR for placenta accreta after 1 Cesarean delivery 11 fold RR with 2 prior Cesarean deliveries 0.25% (1987); 0.82% (2006) –Increase time of recovery 3-4 vs 1-2 days for initial recovery –Increase costs to business (time away and insurance)

20. Because we have pitocin, we… Term IUP, cephalic presentation Induce or Augment labor leading to C/Section –Increase antibiotic exposure 5-10 fold RR –Increased fetal injury 1-2% at Cesarean Section –Increase organ injury 2% at cesarean delivery 5% at hysterectomy –Increased abdominal scarring Small Bowel Obstruction 0.5/1000

21. Because we have pitocin, we… Term IUP, cephalic presentation Induce or Augment labor leading to C/Section –Increased ectopic pregnancies –Increased narcotic use/abuse –Increased infertility 1.5 RR of infertility after cesarean delivery –Increased time to first breastfeeding –Decreased bonding –Decreased birth experience

22. Joint Commission Sentinel Event Alert Issue #44 Causes of maternal death % Preeclampsia16 Amniotic fluid embolism 14 Obstetric hemorrhage 12 Cardiac disease 11 Pulmonary thromboembolism 9 Clark et al. Maternal death in the 21st century: causes, prevention, and relationship to cesarean delivery. AJOG;199:36.

23. Joint Commission Sentinel Event Alert Issue #44 Relationship between route of delivery and maternal death Vaginal 1.7 Primary Cesarean 16.3 Repeat Cesarean 7.4 Total Cesarean 12.7 Totals 6.5 Clark et al. Maternal death in the 21st century: causes, prevention, and relationship to cesarean delivery. AJOG;199:36.

24. Joint Commission Sentinel Event Alert Issue #44 Causal relationship between route of delivery and maternal death Vaginal 0.2 Primary Cesarean 2.5* Repeat Cesarean 1.1 Total Cesarean 2.0* Totals 1.4 *p<0.001 for VD Clark et al. Maternal death in the 21st century: causes, prevention, and relationship to cesarean delivery. AJOG;199:36.

25. Why don’t we feel these numbers… *Absolute numbers are low *Relative Risks are low * 2-4 times a low number is still a low number. * 2-4 times a low number is still a low number.

26. Why don’t we feel these numbers… *Absolute numbers are low * Obstetrician doing 300 del/yr -100 CS -75 IOL * Home birth midwife -100 deliveries/year *10-fold increased maternal death rate - Obstetrician would take 5-10 years to have 1 death -Midwife would take 10-15 years to have 1 death

27. Why don’t we feel these numbers… *Absolute numbers are low * Obstetrician doing 300 del/yr -100 CS -75 IOL * Home birth midwife -100 deliveries/year *5-fold increased neonatal death rate - Obstetrician would take 6-12 months to have 1 death -Midwife would take 18 months to have 1 death

28. Oxytocin Costs Summary 4.3 million USA deliveries (2007) X 25% induction rate = 1.08 million Labor Inductions X 31.3% Cesarean Section Rate = 1.31 million Cesarean Sections –Even low incidence outcomes become important

29. Balancing Measure Fetal Death MacDorman MF, Hoyert DL, Martin JA, Munson ML, Hamilton BE. Fetal and Perinatal Mortality, United States, 2003. National vital statistics reports; vol 55 no 6. Hyattsville, MD: National Center for Health Statistics. 2007.

30. Balancing Measure Perinatal Mortality rate –Fetal MR + Neonatal MR Fetal MR represents 58% of the PMR FMR 6.23 in 2003 –51% of Fetal Mortality occurs at 20-27 wks FMR at 28+ weeks is 3.0 –80.3% of Fetal Mortality occurs prior to term FMR at term is 1.2 Fetal Death – A Primer MacDorman MF, Hoyert DL, Martin JA, Munson ML, Hamilton BE. Fetal and Perinatal Mortality, United States, 2003. National vital statistics reports; vol 55 no 6. Hyattsville, MD: National Center for Health Statistics. 2007.

31. Balancing Measure MacDorman MF, Hoyert DL, Martin JA, Munson ML, Hamilton BE. Fetal and Perinatal Mortality, United States, 2003. National vital statistics reports; vol 55 no 6. Hyattsville, MD: National Center for Health Statistics. 2007. Fetal Death

32. Balancing Measure Oshiro et al. Decreasing Elective Deliveries Before 39 Weeks of Gestation in an Integrated Health Care System. Obstet Gynecol 2009;113:804–11) Fetal Death

33. Our 91%er 0

34. Indicated Labor Induction Phase One: Protocol Development To Induce or not to Induce Setting the Stage

35. The Reliability Design Strategy Prevent initial failure –intent and standardization function Identify failure (defects) and mitigate –Redundancy function Measure and then communicate learning from defects –Redesign function

36. Why Standardize? Contributes to building an infrastructure (who does what, when, where, how and with what) Support training and competency testing to sustain the process Achieve front line articulation of key processes by staff Allows the appropriate application of Evidence Based Medicine consistently Feedback about errors and application of learning to design is possible

37. The Clinical Bundle as Standardization

38. What is a Clinical Bundle A group of clinical events that should happen every time a given process occurs Individual elements based on solid science Emphasis initially on process rather than outcome Based on failure modes Eventual endpoint is outcome improvement

39. Quality Care in Obstetrics Elective Labor Induction-Requirements Elective Oxytocin Labor Induction Bundle  Gestational age > 39 weeks  Category I EFM  Absence of tachysystole with increases in pitocin/Response to tachysystole  Pelvic assessment

40. Quality Care in Obstetrics Augmentation-Requirements Oxytocin Augmentation Bundle  Estimated fetal weight  Category I and some Category II EFM  Absence of tachysystole with increases in pitocin/Response to tachysystole  Pelvic Assessment

41. Quality Care in Obstetrics Indicated Labor Induction Bundle Defined: Patient with a medical indication for induction Acceptable medical indication for labor induction documented (locally defined) Pelvic Assessment Recognition and management of complications of induction method (including tachysystole) Recognition and management of FHR Status –Exclusion of Category III FHR

42. References Al-Took S, Platt R, Tulandi T. Adhesion-related small-bowel obstruction after gynecologic operations. Am J Obstet Gynecol. 1999;180:313-315. Hemminki E. Impact of cesarean section on future pregnancy -- a review of cohort studies. Paediatr Perinat Epidemiol. 1996;10:366-379. Murphy DJ, Stirrat GM, Heron J, et al; ALSPAC Study Team. The relationship between caesarean section and subfertility in a population-based sample of 14,541 pregnancies. Hum Reprod. 2002;17:1914-1917. Lydon-Rochelle M, Holt VL, Martin DP, Easterling TR. Association between method of delivery and maternal rehospitalization. JAMA. 2000;283:2411-2416 Rowe-Murray HJ, Fisher JR. Operative intervention in delivery is associated with compromised early mother-infant interaction. BJOG. 2001;108:1068-1075. E. Sheiner, L. Esarid, A. Levy and D.S. Hallak, Obstetric risk factors and outcome of pregnancies complicated with early postpartum hemorrhage: A population-based study, J Matern Fetal Neonatal Med 18 (2005), pp. 149–154 Clark et al. Maternal death in the 21st century: causes, prevention, and relationship to cesarean delivery. AJOG;199:36.

44. Joint Commission Sentinel Event Alert Issue #44 Patient-based causes of maternal death –Existing medical conditions Obesity –Preeclampsia –Preeclampsia –Amniotic Fluid Embolism –Pulmonary Embolism Clark et al. Maternal death in the 21st century: causes, prevention, and relationship to cesarean delivery. AJOG;199:36.

45. Joint Commission Sentinel Event Alert Issue #44 Causal relationship between route of delivery and maternal death excluding PE Vaginal 0.2 Primary Cesarean 2.5 Repeat Cesarean 1.1 Total Cesarean 2.0 Totals 1.4 Clark et al. Maternal death in the 21st century: causes, prevention, and relationship to cesarean delivery. AJOG;199:36. P=0.07 P=0.38 P=0.08

46. PERFORMANCE Individual Autonomy Guidelines as defined by professional standards Legal space Usual space of action Illegal-normal space the ‘illegal- illegal’ space (for almost all of us!) VERY UNSAFE SPACE Individual Pressures Perceived Vulnerability Belief in Systems- guidelines <1% 5% 50% 80% 100% percent of staff Safety regs & good practices Certification/ accreditation standards Collective memory of experiences Forbidden behavior except under extreme circumstances Forbidden by all 55 in a 55 65 in a 55 85 in a 55 105 in a 55