1. Click to edit Master title style Click to edit Master subtitle style 1 A Note to the Speaker DELETE THIS SLIDE BEFORE PRESENTATION The following slides have been developed to support presentations on the elimination of non-medically indicated deliveries <39 weeks gestational age and should be tailored to meet the needs of the audience. When adapting the slide deck, the following guidelines must be considered: The slide deck is copyrighted by the State of California. Slides contained in this deck should not be changed or amended. Additional slides can be added, but new slides must not contain the CMQCC logo, March of Dimes logo or the State of California copyright.

2. Click to edit Master title style Click to edit Master subtitle style 2 Elimination of Non-medically Indicated (Elective) Deliveries Before 39 Weeks Gestational Age A Quality Improvement Toolkit Funding for the development of this toolkit was provided by: Federal Title V block grant funding from the California Department of Public Health; Maternal, Child and Adolescent Health Division was used by the California Maternal Quality Care Collaborative to develop the toolkit; and March of Dimes.

3. Click to edit Master title style Click to edit Master subtitle style 3 Elimination of Non-medically Indicated (Elective) Deliveries Before 39 Weeks Funding Federal Title V block grant from the California Department of Public Health; Maternal, Child and Adolescent Health Division California Maternal Quality Care Collaborative (CMQCC) March of Dimes

4. Click to edit Master title style Click to edit Master subtitle style 4 Acknowledgments Toolkit Authors: Elliott Main, MD Bryan Oshiro, MD Brenda Chagolla, RN, MSN, CNS Debra Bingham, Dr.PH, RN Leona Dang-Kilduff, RN, MSN Leslie Kowalewski Author Organizations: California Maternal Quality Care Collaborative (CMQCC) California Pacific Medical Center Loma Linda University School of Medicine Catholic Healthcare West California Perinatal Quality Care Collaborative (CPQCC) March of Dimes

5. Click to edit Master title style Click to edit Master subtitle style 5 Letters of Support American Congress of Obstetricians and Gynecologists (ACOG) California (District IX) Florida (District XII) Illinois (Illinois Section, District VI) New York (District II) Texas (District XI) Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN) California National

6. Click to edit Master title style Click to edit Master subtitle style 6 Objectives 1.Describe the increase in non-medically indicated (elective) deliveries before 39 weeks and identify the contributing factors. 2.Discuss the risks of early term deliveries and the benefits of delaying delivery beyond 39 weeks gestation. 3.Outline successful initiatives to reduce elective deliveries before 39 weeks at hospital, health system and statewide levels. 4.Describe a sample implementation plan for the prevention of elective deliveries before 39 weeks.

7. Click to edit Master title style Click to edit Master subtitle style 7 Key Points 1.Research has shown that early elective delivery without medical or obstetrical indication is linked to neonatal morbidities with no benefit for the mother or infant. 2.There are numerous maternal and fetal indications for deliveries BEFORE 39 weeks gestation 3.In addition … this toolkit … is not meant to imply that elective deliveries AFTER 39 weeks have been proven to be without risks for mother and infant.

8. Click to edit Master title style Click to edit Master subtitle style 8 Terminology Modified from Drawing courtesy of William Engle, MD, Indiana University Raju TNK. Pediatrics, 2006;118 1207. First day of LMP 0 Week # 37 0/7 41 6/7 PretermTermPost term 34 0/7 20 0/7 39 0/7 Late PretermEarly Term

9. Click to edit Master title style Click to edit Master subtitle style 9 Inductions of Labor Since 1979, ACOG has cautioned against inductions before 39 weeks in the absence of a medical indication (Committee Opinion #22) ACOG has also noted that “a mature fetal lung maturity test result before 39 weeks of gestation, in the absence of appropriate clinical circumstances, is not an indication for delivery” (Committee Practice Bulletins #97 and #107)

10. Click to edit Master title style Click to edit Master subtitle style 10 Confirmation of Term Gestation Early ultrasound, < 20 weeks gestation, is more accurate than an ultrasound after 20 weeks gestation at determining gestational age and benchmarking < 39 weeks gestation. Ultrasound-established dates should only take precedence over LMP-established dates when the discrepancy is greater than 7 days in the first trimester and 10 days in the second trimester. ACOG Practice Bulletin: Ultrasonography in Pregnancy Number 101, February 2008

11. Click to edit Master title style Click to edit Master subtitle style 11 Change in Distribution of Births by Gestational Age: United States, 1990-2006 Martin JA, Hamilton BE, Sutton PD, Ventura SJ, et al. Births: Final data for 2006. National vital statistics reports; vol 57 no 7. Hyattsville, MD: National Center for Health Statistics. 2009.

12. Click to edit Master title style Click to edit Master subtitle style 12 U.S. Cesarean Section and Labor Induction Rates Among Singleton Live Births by Week of Gestation, 1992 and 2002 Source: NCHS, Final Natality Data, Prepared by March of Dimes Perinatal Data Center, April 2006. Gestational Age (week) 2002 Induction 2002 C-S 1992 C-S 1992 Induction Early Term Percent of Singleton Live Births (%)

13. Click to edit Master title style Click to edit Master subtitle style 13 Rates of Induction of Labor in Singleton Births by Race and Hispanic Origin in the U.S. Martin JA, Hamilton BE, Sutton PD, Ventura SJ, et al. Births: Final data for 2006. National vital statistics reports; vol 57 no 7. Hyattsville, MD: National Center for Health Statistics. 2009.

14. Click to edit Master title style Click to edit Master subtitle style 14 Why are Non-medically Indicated (Elective) Deliveries Increasing in Frequency?

15. Click to edit Master title style Click to edit Master subtitle style 15 Obstet Gynecol 2009;114:1254

16. Click to edit Master title style Click to edit Master subtitle style 16 The Gestational Age that Women Considered a Baby to be Full Term Obstet Gynecol 2009;114:1254 3.3% 17.4% 21.7% 29.1% 4.8% 20.8%

17. Click to edit Master title style Click to edit Master subtitle style 17 The Gestational Age that Women Considered it Safe to Deliver Obstet Gynecol 2009;114:1254 Weeks of Gestation

18. Click to edit Master title style Click to edit Master subtitle style 18 Pressures on Obstetricians Clin Obstet Gynecol 2006;49:698-704 Reasons that physicians may resist elimination of elective deliveries < 39 weeks: Physician Convenience Guarantee attendance at birth (“co-dependency”) Avoid scheduling conflicts Reduce being awakened at night …what’s the harm? Bad outcomes are unrecognized and rare The NICU handles these issues just fine Limit risk of a bad pregnancy outcome

19. Click to edit Master title style Click to edit Master subtitle style 19 Risks of Non-medically Indicated (Elective) Delivery Before 39 Weeks

20. Click to edit Master title style Click to edit Master subtitle style 20 Complications of Non-medically Indicated (Elective) Deliveries Between 37 and 39 Weeks See Toolkit for more data and full list of citations Clark 2009, Madar 1999, Morrison 1995, Sutton 2001, Hook 1997 Increased NICU admissions Increased transient tachypnea of the newborn (TTN) Increased respiratory distress syndrome (RDS) Increased ventilator support Increased suspected or proven sepsis Increased newborn feeding problems and other transition issues

21. Click to edit Master title style Click to edit Master subtitle style 21 Composite Morbidity of Late Preterm Infants in Massachusetts Late preterm infants: 22.2% vs Term infants: 3% Sample: Term (377,638), Late Preterm (26,170) Morbidity rates doubled for each gestational week earlier than 38 weeks 40 wks: 2.5% 39 wks: 2.6% 38 wks: 3.3% 37 wks: 5.9% 36 wks: 12.1% 35 wks: 25.6% 34 wks: 51.9% Shapiro-Mendoza CK et al. Effect of late-preterm birth and maternal medical conditions on newborn morbidity risk. Pediatrics. 2008;121:e223–e232

22. Click to edit Master title style Click to edit Master subtitle style 22 What about 38 weeks + 4 to 6 days? Tita (NEJM 2009;360:111) (MFM Network) Examined 2,463 scheduled CS babies in this age range Respiratory outcomes worse than 39 weeks (RR=1.21 95% CI 1.04- 1.4, p=0.01), similar to 38 weeks as a whole Wilminik (AJOG 2010;202:250.e1-8) (Netherlands) Examined 5,046 scheduled CS babies in this age range Respiratory outcomes worse than 39 weeks (RR=1.4 95% CI 1.1- 1.8, p=0.01), similar to 38 weeks as a whole

23. Click to edit Master title style Click to edit Master subtitle style 23 Neonatal outcomes at 37 and 38 weeks are very similar (or worse) than those at 41 and 42 weeks… Best outcomes are at 39 and 40 weeks! New Concept: U-Shaped Curve for Near-term Neonatal Outcomes

24. Click to edit Master title style Click to edit Master subtitle style 24 NICU Admissions By Weeks Gestation Deliveries Without Complications, 2000-2003 (n=84,538) NICU Admissions Oshiro et al. Obstet Gynecol 2009;113:804-811.

25. Click to edit Master title style Click to edit Master subtitle style 25 Respiratory Distress Syndrome (RDS) By Weeks Gestation Deliveries Without Complications, 2000-2003 (n=84,538) RDS Oshiro et al. Obstet Gynecol 2009;113:804-811.

26. Click to edit Master title style Click to edit Master subtitle style 26 Ventilator Usage By Weeks Gestation Deliveries Without Complications, 2000-2003 (n=84,538) Ventilator Use Oshiro et al. Obstet Gynecol 2009;113:804-811.

27. Click to edit Master title style Click to edit Master subtitle style 27 13,258 elective repeat cesarean births in 19 centers 35.8% were at <39 weeks gestation Increased risk of neonatal morbidity Respiratory, hypoglycemia, sepsis, NICU admissions, hospitalization ≥ 5 days Even among babies delivered at 38-39 weeks Timing of Elective Repeat Cesarean Delivery at Term and Neonatal Outcomes Tita AT, et al. NEJM 2009;360:111

28. Click to edit Master title style Click to edit Master subtitle style 28 Adverse Neonatal Outcomes According to Completed Week of Gestation at Delivery: Absolute Risk Adapted from Tita AT, et al. NEJM 2009;360:111

29. Click to edit Master title style Click to edit Master subtitle style 29 Adverse Neonatal Outcomes According to Completed Week of Gestation at Delivery: Odds Ratios Adapted from Tita AT, et al. NEJM 2009;360:111

30. Click to edit Master title style Click to edit Master subtitle style 30 Timing of Fetal Brain Development Cortex volume increases by 50% between 34 and 40 weeks gestation. (Adams Chapman, 2008) Brain volume increases at rate of 15 mL/week between 29 and 41 weeks gestation. A 5-fold increase in myelinated white matter occurs between 35-41 wks gestation. Frontal lobes are the last to develop, therefore the most vulnerable. (Huttenloher, 1984; Yakavlev, Lecours, 1967; Schade, 1961; Volpe, 2001).

31. Click to edit Master title style Click to edit Master subtitle style 31 Cerebral Palsy among Term and Post-term Births Norwegian birth cohort of 1,682,441 singleton term births without congenital anomalies. Followed for a minimum of 4 years (maximum of 20 years) with identified cerebral palsy in the National Health Insurance Registry. Found that cerebral palsy is 2.3 times higher at 37 weeks and 1.5 times higher at 38 weeks than at 39-41 weeks. Moster et al. JAMA 2010;304:976-982.

32. Click to edit Master title style Click to edit Master subtitle style 32 Examples of Successful Programs to Reduce Non-medically Indicated (Elective) Deliveries Before 39 Weeks of Gestation Magee-Womens Hospital (Pittsburgh) Intermountain Healthcare (Utah) Hospital Corporation of America (HCA)

33. Click to edit Master title style Click to edit Master subtitle style 33 Magee-Womens Hospital’s Experience Magee-Womens Hospital is the largest maternity hospital in western Pennsylvania, performing more than 9,300 deliveries in 2007. A rise in the use of induction, reaching a high of 28% in 2003. In 2006, a process improvement initiative changed the induction scheduling process and strictly enforced the guidelines. Fisch et al. Obstet Gynecol 2009;113:797

34. Click to edit Master title style Click to edit Master subtitle style 34 Magee-Womens Hospital Experience with Guidelines Baseline 3mos 2004 Voluntary 3mos 2005 Enforced 14mos 2006-7 Deliveries2,1392,26010,895 Elective Inductions <39wks (N) Elective Inductions <39wks (rate) 23 11.8% 21 10.0% 30 4.3% (p<0.001) Elective Nullip Inductions (N) Elective Nullip Inductions =>C/S (N) Elective Nullip Inductions =>C/S (rate) 29 10 35.7% 33 5 15.2% 87 12 13.8% (p<0.01) Total Induction Rate24.9%20.1%16.6% Fisch et al. Obstet Gynecol 2009;113:797

35. Click to edit Master title style Click to edit Master subtitle style 35 Magee-Womens Hospital Experience The importance of strong physician and nursing leadership cannot be overstated. The change in the induction scheduling process that began to enforce the guidelines strictly in late 2006 was spearheaded by the OB Process Improvement Committee, whose members included the hospital’s Vice President for Medical Affairs, the Medical Director of the Birth Center, and the nursing leadership for the Birth Center. Fisch et al. Obstet Gynecol 2009;113:797

36. Click to edit Master title style Click to edit Master subtitle style 36 Intermountain Healthcare’s Experience Intermountain Healthcare is a vertically integrated healthcare system that operates 21 hospitals in Utah and southeast Idaho and delivers approximately 30,000 babies annually. Computerized L&D system. MFMs hired by system, but OBs are independent. January 2001: 9 urban facilities participated in a process improvement program for elective deliveries. 28% of elective deliveries were occurring before 39 completed weeks of gestation. Oshiro, B. et al. Obstet Gynecol 2009;113:804-811.

37. Click to edit Master title style Click to edit Master subtitle style 37 % Non-medically Indicated Deliveries <39 Weeks, January 1999 – December 2005 Oshiro, B. et al. Obstet Gynecol 2009;113:804-811. Less than 39 weeks (%)

38. Click to edit Master title style Click to edit Master subtitle style 38 Common Themes Noted in Intermountain Healthcare’s Experience Education provided to obstetricians regarding ACOG guidelines and best practice. Little change until physicians were held accountable, nurses were empowered, and guidelines were enforced. Medical leadership is important.

39. Click to edit Master title style Click to edit Master subtitle style 39 Hospital Corporation of America (HCA) Study 220,000 births annually. Cohort study of 27 pilot hospitals in 2007-2009 Self-selected to either : “Education only”, provision of literature and ACOG recommendations (Group 3) Education and “Soft Stop”, compliance left to individual physicians, cases reviewed in peer review sessions (Group 2) Education and “Hard Stop”, <39 wk elective procedures are not scheduled unless department criteria are met, exceptions through chain of command (Group 1) Careful distinction among “planned” deliveries between “indicated” and “elective” deliveries Clark SL. et al. Am J Obstet Gynecol 2010;203:449.e1-6

40. Click to edit Master title style Click to edit Master subtitle style 40 HCA Trial of 3 Approaches for Reduction of Elective Deliveries <39 Weeks Clark SL. et al. Am J Obstet Gynecol 2010;203:449.e1-6 Hard Stop Soft Stop/ Peer Rev Education Only P=0.007 P=0.025 P=0.135

41. Click to edit Master title style Click to edit Master subtitle style 41 Neonatal Outcomes for HCA Trial Stillbirth Rate Unchanged: 2007: 0.69% 2009: 0.71% Not statistically significant Term NICU Admissions: 2007: 8.9% 2009: 7.5% (decreased 16%) P<0.001 RR=0.85 Clark SL. et al Am J Obstet Gynecol 2010; 203:449

42. Click to edit Master title style Click to edit Master subtitle style 42 Alleviating Obstetricians’ Fears About Delaying Delivery Obstetricians in several of these studies voiced concerns regarding a potential increase in perinatal mortality and maternal morbidity. It should be recognized that the guidelines are for low- risk uncomplicated patients. Patients with medical issues should be evaluated for possible earlier delivery.

43. Click to edit Master title style Click to edit Master subtitle style 43 Stillbirths Before and After Implementation of Guidelines at Intermountain Healthcare Oshiro, B. et al. Obstet Gynecol 2009;113:804-811. 1999-2000July 2001 to June 2006 Weeks of Gestation StillbirthsDeliveries%StillbirthsDeliveries%Odds Ratio 95% CI 37174,1170.412213,0770.170.4060.22-0.77 38199,9540.192128,2090.070.3900.21-0.72 391013,7520.072851,7210.050.7440.36-1.53 40107,9250.131424,1400.060.4590.20-1.03 4121,9380.1035,5710.050.5220.09-3.12 All5837,6860.1588122,7180.070.4660.33-0.65

44. Click to edit Master title style Click to edit Master subtitle style 44 Wouldn’t Keeping Women Pregnant for Longer Increase Their Risk of Adverse Outcomes? The experience in Utah has shown that morbidity remained the same for macrosomia, preeclampsia, and maternal infections. Decreases were seen in stillbirth, low Apgar scores, cesarean section for fetal distress, meconium aspiration and postpartum anemia.

45. Click to edit Master title style Click to edit Master subtitle style 45 What About the Risk of Stillbirths? Even one day longer “in-utero” does increase the risk for stillbirth, but it is extremely low. What is the reported risk of stillbirth during the 38th week? U.S. data (NCHS) 1 = 0.36/1,000 births Population rate - includes all risk categories 1 MacDorman MF, Kirmeyer SE, Wilson EC. Fetal and perinatal mortality, United States, 2006. National vital statistics reports; vol 60 no 8. Hyattsville, MD: National Center for Health Statistics. 2012.

46. Click to edit Master title style Click to edit Master subtitle style 46 What Have Intervention Studies Observed for the Risk of Stillbirth? Intervention StudyTotal Population Studied Stillbirth Rate Findings Oshiro (2009) 1 (large health system) 160,394Decline during intervention period Clark (2010) 2 (large health system) 433,551No change during the intervention period Ehrenthal (2011) 3 (single hospital) 24,028 (>37 wk only)Increase noted at 37 and 38 wks Benedetti (2012) 4 (state of Washington) 505,445 (>37wk only)No change during the intervention period 1 Obstet Gynecol 2009;113:804–11 2 Am J ObstetGynecol 2010;203:449.e1-6 3 Obstet Gynecol 2011;118:1047–55 4 Obstet Gynecol 2012;119:656-7

47. Click to edit Master title style Click to edit Master subtitle style 47 Increased Infant Mortality (birth to 1 year) for Babies Born at 37/38wks Gestation Compared to 39wks or Greater StudyRelative Risk compared to 39 wks Absolute Increase per 1,000 births Zhang (2009) 1 (US cohort, 1995-2001) 37wk: 1.75 38wk: 1.25 37wk: 1.0 38wk: 0.3 Donovan (2010) 2 (Ohio 2003-2005) 37wk: 1.9 38wk: 1.4 37wk: 1.8 38wk: 0.8 Reddy (NICHD)(2011) 3 (NCHS US 1995-2001) 37wk: 1.9 38wk: 1.4 37wk: 2.0 38wk: 0.5 Altman (2012) 4 (Sweden 1983-2006) 37wk: 2.1 38wk: 1.4 37wk: 1.6 38wk: 0.5 1 J Pediatric 2009;154:358-62 2 Am J ObstetGynecol 2010;203:58 3 Obstet Gynecol 2011;117:1279-87 4 BMJ Open 2012;2:e001152 Results are quite consistent and show higher rates of observed infant mortality at 37/38 weeks than predicted for fetal mortality.

48. Click to edit Master title style Click to edit Master subtitle style 48 Strong Support for this Initiative American College of Obstetricians and Gynecologists (ACOG) Centers for Medicare & Medicaid Services (CMS), US Department of Health & Human Services (HHS) National Quality Organizations: The Joint Commission, Leapfrog Group, National Quality Forum (NQF) measures March of Dimes State Medicaid program are exploring options: “Do not pay”, withholds, incentives, pre-authorizations Commercial insurance has acted in several states Many perinatal collaboratives

49. Click to edit Master title style Click to edit Master subtitle style 49 Summary: Reasons to Eliminate Non-medically Indicated (Elective) Deliveries Before 39 Weeks Reduction of neonatal complications No harm to mother if no medical or obstetrical indication for delivery Now a national quality measure: National Quality Forum (NQF) Leapfrog Group The Joint Commission (TJC)

50. Click to edit Master title style Click to edit Master subtitle style 50 Eliminating Non-medically Indicated (Elective) Delivery Before 39 Weeks in Our Hospital: What are the steps to make this happen?

51. Click to edit Master title style Click to edit Master subtitle style 51 First Steps (Fundamentals) Implement list of “approved” indications Have departmental criteria for making certain diagnoses (e.g. hypertensive complications of pregnancy) Identify strong medical leadership and empower nurses to handle “appeals” for exceptions Implement criteria for establishing gestational age 39 + weeks Gather baseline data

52. Click to edit Master title style Click to edit Master subtitle style 52 ACOG: “Examples of maternal or fetal conditions that may be indications for induction of labor” The Joint Commission: National Quality Core Measure PC-01—Specifications for “Conditions justifying delivery <39 weeks” Abruptio placenta Placental abruption, placenta previa, unspecified antenatal hemorrhage Fetal demise Fetal demise, fetal demise in prior pregnancy Post-term pregnancy Premature rupture of membranes Rupture of membranes prior to labor (term or preterm) Gestational hypertension, preeclampsia, eclampsia, chronic hypertension Maternal medical conditions, e.g., diabetes, renal disease, chronic pulmonary disease, antiphospholipid syndrome Preexisting diabetes, gestational diabetes Renal disease Maternal coagulation defects in pregnancy (including anti-phospholipid syndrome) Liver diseases (including cholestasis of pregnancy) Cardiovascular diseases (congenital and other) HIV infection Fetal compromise, e.g., severe Intrauterine Growth Restriction (IUGR), isoimmunization, oligohydramnios IUGR, oligohydramnios, polyhydramnios, fetal distress, abnormal fetal heart rate Isoimmunization (Rh and other), fetal-maternal hemorrhage Fetal malformation, chromosomal abnormality, or suspected fetal injury These are NOT exhaustive lists! ACOG Practice Bulletin: Induction of Labor. Number 107, August 2009. TJC Specifications Manual for Joint Commission National Quality Core Measures (20101a); Perinatal Care Core Measure Set. 2009.

53. Click to edit Master title style Click to edit Master subtitle style 53

54. Click to edit Master title style Click to edit Master subtitle style 54 Available in the Toolkit

55. Click to edit Master title style Click to edit Master subtitle style 55 Sample Scheduling Form Available in the Toolkit

56. Click to edit Master title style Click to edit Master subtitle style 56 A Tool to Educate Patients marchofdimes.com© 2007 Bonnie Hofkin Illustration

57. Click to edit Master title style Click to edit Master subtitle style 57 For More Information, Contact: Barbara Murphy barbar@stanford.edu Leslie Kowalewski LKowalewski@marchofdimes.com