1. CONFIDENTIAL WSHA CQIP Peer Review and Quality Improvement Information. Protected from disclosure or discovery under RCW 43.70.510

2. 22 Elliott Main, MD CMQCC Principal Investigator main@.org Chair, Dept OB GYN California Pacific Medical Center San Francisco Reducing Cesarean Section Rates in the Nulliparous Term Singleton Vertex Populations

3. : Transforming Maternity Care Topics: What are the drivers of the rise in Cesareans? What are the risks to Cesareans? (new data) Marked Variation in CS rates--Public Release NTSV as the focus for Cesarean QI Importance of L&D culture & Labor practices The Joint Commission Measures

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5. Cesarean Births Have Risen by Over 50% in the Last 10 years

6. : Transforming Maternity Care Why Have Cesarean Rates Risen? Cesarean Rate Pt Desire MD Time Sched- ule MD Worry Fear of Labor Per- fection MD Pride Peer PressureSafety Long LOS What happens if no one cares about the rate?

7. Cesareans are not Risk-free New Data

8. : Transforming Maternity Care Is There a New Risk/Benefit Calculus for Cesarean Birth? Old Calculus: “There may be some risks to CS but they are very small…”  With today’s level of care (anesthesia and medical support)  When done on “low risk” women Therefore, the theoretical “benefits of preserved perineums and less neonatal trauma” (both highly controversial) “outweigh these concerns”.

9. : Transforming Maternity Care Recent Data on Cesarean Risks (1) Liu S et al (CMAJ 2007;176:455-60) Review of all low-risk healthy mothers with elective CS for breech presentation in Canada, compared to healthy mothers attempting vaginal birth (47k vs 2.3m) Severe morbidity: 27.3 CS, 9.0 Vag (per 1,000) CS increased the risks of: cardiac arrest (OR=5.1), wound hematoma (OR=5.1), major infection (OR=3.0), anesthetic complication (OR=2.3), hysterectomy (OR 2.1)

10. : Transforming Maternity Care Recent Data on Cesarean Risks (2) Schutte JM et al (Acta Obstet Gynecol Scand 2007;86:240-3) Review of all elective CS (>8,500) for breech presentation in the Netherlands, 2000-2002 4 maternal mortalities (2 VTE, 2 sepsis) for a rate of 1 per 2,127 elective cesareans

11. : Transforming Maternity Care Recent Data on Cesarean Risks (3) Spong CY et al (Obstet Gynecol 2007; 110:801-7) MFM Network Study comparing: Elective Repeat CS (no indication, no labor), N=14,983 (no previas or accretas) Trial of Labor, N=15,323 University Medical Centers with 24/7 coverage Neonatal Deaths Maternal Deaths TOL121 Elec Rpt CS65 Elective Rpt CS: 5 maternal deaths were direct: 3 AFE, 1 hemorrhage, 1 anesthetic related

12. : Transforming Maternity Care Recent Data on Cesarean Risks (4) Wen SW et al (AJOG 2004; 110:801-7) Canadian Network Study comparing: 1) Elective Repeat CS (low risk) N=179k 2) Trial of Labor (low risk), N=129k TOL: 2 maternal deaths (1.6/100k) Elec Rpt CS: 10 maternal deaths (5.6/100k) Risk ratio =3.6

13. : Transforming Maternity Care Recent Data on Cesarean Risks (5) Knight et al (Ob Gyn 111:97-105, 2008) Review of all UK peripartum hysterectomies, rate = 1/2,500 births Prior CS is a major risk: 1 prior CS OR=2.1 2+ prior CS OR=18.6 controlled for maternal age, parity, twins, indication for CS

14. : Transforming Maternity Care Data courtesy of David Lagrew, MD Long Beach Memorial Peripartum Hysterectomy Trends

15. : Transforming Maternity Care Risks of Being a Prior Cesarean… Decisions around VBAC-TOL vs. Rpt CB Risk of Uterine Rupture Risk of Hemorrhage/Transfusions Epidemic of Placenta Previas Epidemic of Placenta Accretas Marked Increase of Peripartum Hysterectomies

16. : Transforming Maternity Care But are neonatal outcomes better with higher CS rates? Cerebral Palsy rates have been stable for the last 25 years Term neonatal outcomes (neonatal seizures, NICU LOS, ventilator requirement) have not improved over the last 15 years (with the exception of the reduction of postdates babies) Surman G, etal. Children with cerebral palsy: severity and trends over time. Paediatr Perinat Epidemiol. 2009 Nov;23(6):513-21. Strauss D, etal. Survival in cerebral palsy in the last 20 years: signs of improvement? Dev Med Child Neurol. 2007 Feb;49(2):86-92.

17. : Transforming Maternity Care Neonatal Outcomes Worsen when the Cesarean Rate is Higher than Predicted (I) Bailit JL, etal. Hospital primary cesarean delivery rates and the risk of poor neonatal outcomes. Am J Obstet Gynecol. 2002;187:721-7. Data from Washington State birth linked data set, 1995-1996 Cesarean Predictive model from maternal demographics and medical complications resulting in an U-Shape curve for baby outcomes

18. : Transforming Maternity Care Neonatal Outcomes Worsen when the Cesarean Rate is Higher than Predicted (II) Gould JB, etal. Cesarean delivery rates and neonatal morbidity in a low- risk population. Obstet Gynecol. 2004;104:11-9. Data from California birth linked data set, 1998-2000 Cesarean Predictive model for low-risk singletons from maternal demographics and medical complications resulting in an U-Shape curve for baby outcomes. Approximately 40% worse outcomes in either direction.

19. : Transforming Maternity Care Consequences… Neonatal Outcomes NOT improved Maternal Outcomes raise concern  Mortality increasing  Morbidity increasing What is really driving the change?  Unit culture

20. Marked Variation Public Release of Cesarean Data

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22. NY Public Citizen: Web reports of Hospital CS 2007 Data (released 4/21/10)

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26. Issues: Primary CS rate- right measure? Any other adjusters? “My patients are high risk…” Attribution? Midwives, FP Statistical analysis? 36% 48% 37% 52% 16% 5% Physician Level Reporting of CS Rates

27. : Transforming Maternity Care California Maternity Outcomes Show Large Variation (3 to 20-fold) County Level Data  Maternal Mortality  Risk-adjusted Cesarean Birth  Infant Mortality Hospital Level Data  Obstetric Hemorrhage (0.5 to 14.2%)  Maternal Infection (0.2% to 5.1%)  Risk-adjusted Cesarean Birth (Nuliparous, Term, Singleton, Vertex, age-adjusted)  Exclusive Breast-feeding at Discharge  3 rd /4 th Lacerations (fully risk-adjusted) : Transforming Maternity Care

28. Low-Risk Primary Cesarean Section Defined: Number of Cesarean births per 100 births among women who have not previously had a Cesarean section and excludes abnormal presentations, preterm gestations, fetal deaths, multiple gestations, and breech presentations (all strong reasons to perform a cesarean section and are relatively common: 2-8%); Primary C/S rates are age-adjusted. OSHPD Data 2006

29. : Transforming Maternity Care Age-Adjusted Low-Risk Primary C/S Rates distributed to quintiles and applied to regions: Quintile 1 (0-20%): CS rate: 5-13.9% Quintile 2 (20-40%): CS rate: 14-15.9% Quintile 3 (40-60%): CS rate: 16.1-16.9% Quintile 4 (60-80%): CS rate: 17-19% Quintile 5 (80-100%): CS rate: >19% Low High

30. : Transforming Maternity Care Top and Bottom two Quintiles (40%) of Age-adjusted Low-Risk Primary C/S Rates: Northern CA HIGH: Hospitals with rates > 17% n = 32/124 (25%) LOW: Hospitals with rates < 16% n=74/124 (60%) 60%25%

31. : Transforming Maternity Care Top and Bottom two Quintiles(40%) of Age-Adjusted Low Risk Primary C/S Rates: Southern CA Hoag memorial Scripps La Jolla HIGH: Hospitals with rates >17% n=34/80 (43%) LOW: Hospitals with rates < 16% n=40/80 (50%) 50%43%

32. : Transforming Maternity Care Top and Bottom two Quintiles (40%) of Age-Adjusted Low-Risk Primary C/S Rates: LA County CA HIGH: Hospitals with rates >17% n=44/60 (73%) LOW: Hospitals with rates < 16% n=12/60 (20%) 20%73%

33. : Transforming Maternity Care How Many Labor Cesareans are done Without an Indication? Surprisingly few

34. The First Pregnancy is the Focus NTSV

35. : Transforming Maternity Care Which Obstetric Population to Examine? Risk adjustment by logistic regression: (changes each year and difficult to calculate) Case Mix analysis: divide gravidas into 10 groups: (complex) NTSV: Nulliparous, Term, Singleton, Vertex  Allows comparison of “apples to apples”  ~40% of most units’ population  Accounted for most of the Cesarean variation within Sutter Health’s 20 maternity units  Easily calculated with birth certificate data  Supported by ACOG (2000) and HP 2010 Main E, etal. Am J Obstet Gynecol 2004; 190: 1747-56.

36. : Transforming Maternity Care Importance of NTSV population to the CS rate 98% of inter- institutional variation in overall CS rates can be attributed to NTSV (TSCN) rates Brennan DJ. Am J Obstet Gynecol 2009; 201: 308.e1-8.

37. : Transforming Maternity Care How do Obstetric Practices Effect CS Rates? Definitions: NTSV: Nulliparous, Term, Singleton, Vertex Induction: use of oxytocin, prostaglandins, AROM, or mechanical techniques to begin labor between 37 and 41 weeks. For this measure  41 wks was considered a “free pass”. Early Labor Admission: under 3cm dilation at time of decision for hospital admission. For this measure women with ROM, bleeding, or other reasons not to do an admission cervical exam were excluded Main E, etal. Am J Obstet Gynecol 2006; 194: 1644-52.

38. : Transforming Maternity Care NTSV Induction Rate Correlates with NTSV Cesarean Rate 0% NTSV <41wks Induction Rate NTSV CB Rate 10% 15% 20% 25% 30% 10%20% 30%40% r = 0.57 (r 2 =0.32) p<0.0001 -20 Hospitals -Circle size is proportionate to birth rate Main E, etal. Am J Obstet Gynecol 2006; 194: 1644-52.

39. : Transforming Maternity Care NTSV Early Labor Admit Rate Correlates with NTSV Cesarean Rate NTSV Early Labor (<3cm) Admission Rate 10% 15% 20% 25% 30% 10%20%50%60% 30%40% r = 0.62 (r 2 =0.38) p<0.0001 NTSV CB Rate -20 Hospitals -Circle size is proportionate to birth rate Main E, etal. Am J Obstet Gynecol 2006; 194: 1644-52.

40. : Transforming Maternity Care Combined Induction+Early Admit Rate Correlates BEST with NTSV Cesarean Rate 10% 15% 20% 25% 30% 20%40%60%80% NTSV Induction Rate + Early Labor Admission Rate NTSV CB Rate r = 0.73 (r 2 =0.53) p<0.0001 Induc. Early Admit All Births Main E, etal. Am J Obstet Gynecol 2006; 194: 1644-52.

41. : Transforming Maternity Care Dilation < 3cm at Time of Admit Decision & Risk of Cesarean Birth Data from Sutter Health FPAD: 2001-2002 Elliott Main, MD (inductions excluded N = 4,151) Relative Risk = 1.9 p <.00001

42. : Transforming Maternity Care Cleveland Metro: 3,087 Low Risk NTSV women in spontaneous labor (1993-2001) Bailit J etal: Obstet Gynecol 2005;105:77-9. Dilation < 3cm at time of Admit Decision & Risk of Obstetric Complications

43. : Transforming Maternity Care Bailit J etal: Obstet Gynecol 2005;105:77-9. More Nullips than Multips present in Latent Phase: 51% Nullip v. 28% Multip OR Active Phase Arrest2.2 p<0.001 Oxytocin Use2.3 p<0.001 IUPC Use2.2 p<0.001 Chorioamnionitis2.7 p<0.001 Latent Phase Admits in Nullips had more… Dilation < 3cm at time of Admit Decision & Risk of Obstetric Complications

44. : Transforming Maternity Care Dilation < 3cm at time of Admit Decision & Risk of Obstetric Complications Big Question: Are these findings cause or effect? 1)Does early presentation in latent phase lead to physician interventions and subsequent dystocia/FTP? Or… 2)Do inherent labor abnormalities result in latent phase presentation and physician interventions?

45. : Transforming Maternity Care An Early Labor Assessment Program: A Randomized Controlled Trial McNiven et al: Birth 1998;25:5-10. RCT of 209 Low-Risk Nullips <3cm dilation oAssessment: encouraged to go home or walk extensively after “advice, support and encouragement” oDirect Admit: admitted without outpt assessment “Asmnt” “Direct Admit” Admit to Delivery Time: 8.3 hrs13.5 hrs p<0.0001 Oxytocin use: 22.8% 40.4% p<0.007 Felt “In control” (score):158142 p<0.0002 Cesarean Birth:7.6%10.5% n.s (underpowered for this outcome and this low rate)

46. : Transforming Maternity Care What are the concerns of women seeking admission during latent phase? In-depth interviews 2-6 weeks PP (Sweden) 5 Key reasons/themes:  “Longing to complete the pregnancy”  “Having difficulty managing the uncertainty”  “Having difficulty enduring the slow progress”  “Suffering from pain to no avail”  “Oscillating between powerfulness and powerlessness” These provide a base for validating concerns and supporting women in OB Triage Carlsson IM, Hallberg LR, Odberg Pettersson K. Swedish women's experiences of seeking care and being admitted during the latent phase of labour: a grounded theory study. Midwifery. 2009;25:172-80.

47. : Transforming Maternity Care Principles for Optimal Management of Women in Latent Phase-I Setting Expectations: “Early labor is best to be done at home”  Office handout about “When to come in for Labor”  Direct discussions with providers  Discussions and Handouts in Prenatal Classes about Early Labor Remember: different rules for Nullips than for Multips!

48. : Transforming Maternity Care Principles for Optimal Management of Women in Latent Phase-II Triage Evaluation & Care: Nursing is Critical! Fetal evaluation = Reassurance  Key Communications: Encouragement, Support, Alleviation of Anxiety  Review of Coping Techniques—Handouts for Partner  Hydration and Nutrition  A subset: Therapeutic Rest: 15mg of Morphine IM – OK to send home after MS, 80%+ will awake in active phase labor  Need MD “Buy-in”

49. : Transforming Maternity Care Oxytocin Safety and Quality IHI Perinatal Bundles HCA/Steve Clark Oxytocin Safety Initiative Common features  Pre-use checklist  Modest increase regimen  In-use checklist to confirm fetal wellbeing and minimize tachysystole Clark S, etal. Implementation of a conservative checklist-based protocol for oxytocin administration: maternal and newborn outcomes. Am J Obstet Gynecol. 2007;197:480.e1-5. IHI Perintal Bundles: http://www.ihi.org/IHI/Topics/PerinatalCare/PerinatalCareGeneral/EmergingContent/ElectiveInd uctionandAugmentationBundles.htm

50. : Transforming Maternity Care + -

52. Effect of Maternal Age on NTSV Cesarean Rate is Continuous from Age 17 Sutter Health Data: 2001-2003: 41,416 NTSV births Age 35 For ages 17 - 42 yrs, r 2 = 0.961 (p<0.001) Main E, etal. Am J Obstet Gynecol 2006; 194: 1644-52.

53. : Transforming Maternity Care + - This is an OSHPD measure, similar to FPAD but includes multips (excludes all prior CS), and is age-adjusted.

54. : Transforming Maternity Care In Effort to Limit C-Sections, Two Methods Yield Different Results on Staten Island Staten Island University Hospital  23.2% Cesarean rate  Strong leadership and determination  No elective inductions prior to 41 wks  No elective CS  Non-interventionist policy Richmond University Medical Center  48.3% Cesarean rate  “Perinatal Center” ( for high-risk pregnancies)  “Peer Review” to reduce CS  2nd opinions for elective CS (half- hearted?) Susan Dominus NYT April 19, 2010

55. National Quality Measures for Obstetrics NQF Leapfrog Group The Joint Commision

56. : Transforming Maternity Care Our Strategy…. First, develop measures and identify confidential outcome data Second, provide high quality QI programs to assist providers in meeting the measures Third, partner for public release, and alignment of financial incentives

57. : Transforming Maternity Care JC Core Measure Set-2010 NQF National Obstetric Quality Measures/Quality Standards (November 2008) Leapfrog Group Measures-2009 Episiotomy rate Cesarean rate for low-risk first births Elective delivery prior to 39 weeks Prophylactic antibiotics for Cesarean birth DVT prophylaxis for women having a Cesarean birth Exclusive breastfeeding at hospital discharge Birth trauma rate (limited ICD9 codes) Rate of antenatal steroids for under 32 week births Infants under 1500g (VLBW) not delivered at Level III center OB/ Mom OB/B aby ( to be added in 2011) CHART: Public Release VBAC Available?

58. : Transforming Maternity Care Keys to Success…Summary Leadership!! Medical and nursing Use external pressures and aligned incentives Focus on the culture on Labor and Delivery Fewer Inductions, more “gentle” oxytocin (protocol driven), admit in active labor whenever possible Public and professional education

59. : Transforming Maternity Care What has resonated best in our system… Focus on changing practices that reduce indications to do a cesarean rather than reducing cesareans once the indication is already there…

60. : Transforming Maternity Care How to get Cesarean Rates back in the box Cesarean Rate Pt Ed MD Time Sched- ule MD Worry Fear of Labor Per- fection Labor mgmt Leader- ship Ed Safety Align $ Work with medical liability companies

61. : Transforming Maternity Care Thank You!

62. : Transforming Maternity Care CONFIDENTIAL WSHA CQIP Peer Review and Quality Improvement Information. Protected from disclosure or discovery under RCW 43.70.510