1. Every Week Counts Lisa M. Hollier, MD, MPH, FACOG Chair, District XI American Congress of Obstetricians and Gynecologists

2. Objectives At the completion of this lecture, the participant will be able to: – Weigh the evidence associated with delivery < 39 weeks – Identify barriers to implementation of new policies to improve neonatal outcomes by reducing NMI early deliveries – Describe solutions for common obstacles – Discuss potential consequences for failure of new programs and policies

3. Conflicts of Interest According to ACCME policy, speakers must disclose all associations with proprietary entities that may have a direct relationship to the subject matter of the lecture. They must also disclose any discussion of unlabeled or unapproved uses of products. – I have no such financial relationships – I will not discuss unlabeled or unapproved uses of products

4. Cesarean and Labor Induction Rates- Singletons, 1992 and 2002 Source: NCHS, Final Natality Data, Prepared by March of Dimes Perinatal Data Center, April 2006. 2002 Induction 2002 C-S 1992 C-S 1992 Induction Early Term

5. Rates of Induction of Labor by Race and Hispanic Origin in the U.S. Martin JA, et al. Births: Final data for 2006. National vital statistics reports; 57(7): NCHS 2009.

6. Late Preterm Births in the US 1990-2006

7. Increase in Rates in LPTB by State

8. MFMU Network Study- NEJM 2009 Observational cohort including 19 different hospitals and 24,000 patients 35.8% of the elective Cesarean deliveries were performed before 39 weeks – infants delivered at 38 weeks had a 1.5x greater chance of being admitted to NICU – infants delivered at 37 had a 2x greater chance of being admitted to NICU – gestational age with the lowest risk for neonatal complications was 40 weeks. Tita ATN et al. NEJM 2009;360:111

9. Tita ATN et al. NEJM 2009;360:111. Neonatal Outcomes by Gestational Age at Delivery

10. Adverse Neonatal Outcomes by Gestational Age at Delivery Tita ATN et al. NEJM 2009;360:111

11. NICU Admissions By Weeks Gestation Deliveries Without Complications, 2000-2003 NICU Admissions Oshiro et al. Obstet Gynecol 2009;113:804-811.

12. Infant Mortality Rate by GA among singleton live births 1995- 2006 Reddy U et al. Obstet Gynecol 2011;117:1279-87

13. Timing of Fetal Brain Development Cortex volume increases by 50% between 34 and 40 weeks gestation. 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; Adams Chapman, 2008

14. Induction and Cesarean Delivery Copyright © 2011 Obstetrics & Gynecology. Published by Lippincott Williams & Wilkins. 14 Vrouenraets FP et al. Obstet Gynecol 2005;105(4):690-697.

15. Induction and Cesarean Delivery Copyright © 2011 Obstetrics & Gynecology. Published by Lippincott Williams & Wilkins.

16. Dilation and Cesarean Delivery Rate Clark SL et al. Am J Obstet Gynecol 2009;200:156.e1-156.e4.

17. Implementing a Successful Program

18. Decision to implement a quality initiative Recruit appropriate leadership Develop/revise hospital policy for elective delivery Active enforcement of policy Public Awareness Campaign Collect and report QI data

19. Intermountain Health Experience Copyright © 2011 Obstetrics & Gynecology. Published by Lippincott Williams & Wilkins. Rate of neonatal intensive care unit admissions Oshiro, BT et al. Obstet Gynecol 2009;113(4):804-811.

20. Elective deliveries < 39 wks Copyright © 2011 Obstetrics & Gynecology. Published by Lippincott Williams & Wilkins. 20 Oshiro, BT et al. Obstet Gynecol 2009;113(4):804-811.

21. Stillbirth Rates Before & After Courtesy of March of Dimes

22. Magee Women’s Experience Baseline 3 months 2004 Voluntary 3 months 2005 Enforced 14 months 2006-7 Deliveries2,1392,26010,895 Elective Inductions <39 weeks (N) Elective Inductions < 39 weeks (rate) 23 11.8% 21 10% 30 4.3% Total Induction Rate24.9%20.1%16.6% “Voluntary”: educational program and department recommendations “Enforced”: department standard requiring approval by the Perinatal Committee chair before scheduling non-standard indications for inductions Fisch et al. Obstet Gynecol 2009:113:797

23. HCA Experience 2007 N (%) 2009 N (%) P value Deliveries17,79417,221NA Deliveries ≥37 wk, n14,99514,863NA Planned + elective deliveries at 37.0-38.6 wk, n 65624349<.001 Elective deliveries at 37.0-38.6 wk, n (%)1712(9.6)746(4.3)<.001 Group 1: 7 hospitals, n/N (%)320/3886(8.2)65/3818(1.7).007 Group 2: 9 hospitals, n/N (%)403/4797(8.4)155/4646(3.3)<.025 Group 3: 11 hospitals, n/N (%)989/9111(10.9)526/8757(6.0).135 Neonatal intensive care unit admissions at ≥37 wk, n (%) 1328(8.9)1119(7.5)<.001 Clark SL. et al. Am J Obstet Gynecol 2010;203:449.e1-6

24. Hard Stop Soft Stop/ Peer Review Education Only HCA Experience Clark SL. et al. Am J Obstet Gynecol 2010;203:449.e1-6

25. Oklahoma Experience

27. Deliveries < 39 wks without Indication

28. Cesarean Delivery < 39 weeks

29. Inductions < 39 weeks

30. Post Intervention Deliveries by Indication and Gestational Age

31. Deliveries < 39 wks without Indication

32. Cesarean Delivery < 39 weeks

33. Inductions < 39 weeks

34. Oklahoma Experience A number of hospitals already low rates of nonmedically indicated early deliveries Many hospitals have implemented successful programs Some hospitals still have high rates of nonmedically indicated delivery

35. ACOG Practice Bulletin Labor also may be induced for logistic reasons, for example, risk of rapid labor, distance from hospital, or psychosocial indications. In such circumstances, at least one of the gestational age criteria in the box should be met, or fetal lung maturity should be established. A mature fetal lung test result before 39 weeks of gestation, in the absence of appropriate clinical circumstances, is not an indication for delivery.

36. From the Trenches That’s not how my babies do This is an “overly restrictive policy” It’s really a medical indication No, really, she’s 39+ weeks It’s not an induction, it’s an augmentation

37. That’s not how my babies do In addition to the authors, the members of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal–Fetal Medicine Units Network are as follows: Ohio State University — J. Iams, F. Johnson, S. Meadows, H. Walker; University of Alabama at Birmingham — D. Rouse, J. Hauth, A. Northen, S. Tate; University of Texas Southwestern Medical Center — S. Bloom, J. McCampbell, D. Bradford; University of Utah — M. Belfort, F. Porter, B. Oshiro, K. Anderson, A. Guzman; University of Chicago — J. Hibbard, P. Jones, M. Ramos-Brinson, M. Moran, D. Scott; University of Pittsburgh — K. Lain, M. Cotroneo, D. Fischer, M. Luce; Wake Forest University — M. Harper, M. Swain, C. Moorefield, K. Lanier, L. Steele; Thomas Jefferson University — A. Sciscione, M. DiVito, M. Talucci, M. Pollock; Wayne State University — M. Dombrowski, G. Norman, A. Millinder, C. Sudz, B. Steffy; University of Cincinnati — T. Siddiqi, H. How, N. Elder; Columbia University — F. Malone, M. D'Alton, V. Pemberton, V. Carmona, H. Husami; Brown University — H. Silver, J. Tillinghast, D. Catlow, D. Allard; Northwestern University — M. Socol, D. Gradishar, G. Mallett; University of Miami — G. Burkett, J. Gilles, J. Potter, F. Doyle, S. Chandler; University of Tennessee — W. Mabie, R. Ramsey; University of Texas at San Antonio — O. Langer, S. Barker, M. Rodriguez; University of North Carolina — K. Moise, K. Dorman, S. Brody, J. Mitchell; University of Texas at Houston — L. Gilstrap, M. Day, M. Kerr, E. Gildersleeve; Case Western Reserve University — P. Catalano, C. Milluzzi, B. Slivers, C. Santori; George Washington University Biostatistics Center — E. Thom, S. Gilbert, H. Juliussen-Stevenson, M. Fischer; Eunice Kennedy Shriver NICHD — D. McNellis, K. Howell, S. Pagliaro.

38. That’s not how my babies do First, the majority of deliveries occurring between 38 and 39 weeks of gestation do not result in harm. The absolute number of newborn respiratory complications is low. If an obstetrician performs 200 deliveries a year and 10% of his or her patients are electively delivered at 38 weeks of gestation, only one neonate would be admitted to the NICU per year.

39. This is an overly restrictive policy Protocols and strong guidelines are used extensively in Internal Medicine and Surgery Door-to-cath times, use of ASA and β-blockers Pre-operative antibiotics and VTE prevention Stroke: very strict protocols Publicly reported, payment-based standards OB has been “below the radar” Movement has now been taken up by commercial insurers and Medicaid

40. It’s really a medical indication Edema Impending macrosomia

41. Spong, CY et al; Obstet Gynecol 2011;118:323-333.

42. Really, she’s 39+ weeks Induction not approved due to GA < 39 weeks with no medical indication Pregnancy dated by LMP consistent with 10 week CRL 34 week ultrasound showed EFW at 75 th percentile and CGA was 2 weeks further along – New posting sheet sent with “revised” EDD

43. It’s not an induction, … augmentation

44. Quality Marker The Joint Commission, CMS, Agency for Healthcare Research and Quality, National Quality Forum, and many insurers have listed NMI early term deliveries as a perinatal quality measure.

45. How Do You Measure Elective Deliveries <39 weeks? (The Joint Commission Measure Definition) TJC (PC-01) v2011A (latest for 2011) Denominator37+0 to 38+6 week births without a STANDARD medical or OB complication NumeratorInductions and CS NOT in Active Labor or with ROM Benchmark?? <5-6% https://manual.jointcommission.org/bin/view/Manual/WebHome

46. These are not exhaustive lists! But close… (e.g. prior classical CS)

47. Caveats about the Indication List The Joint Commission list was developed for ease of data collection utilizing ICD-9 codes. If there is not an ICD-9 code for an indication, they did not list it (e.g. prior classical CS). Everyone understands that there are cases in which earlier delivery is indicated and but the indication is NOT on the list—but these should be uncommon. No one is expecting a ZERO rate. Off-list indications should be prospectively scrutinized

48. www.leapfroggroup.org/tooearlydeliveries

49. HB 1983 Effective Oct 1, Texas Medicaid will require providers to use CPT modifier for deliveries less than 39 weeks Texas Medicaid is be able to recoup payment from hospital and doctor for any NMI deliveries < 39 wks – No time limit – Potential fraud if bill for NMI delivery

50. Summary Reduction of neonatal complications No harm to mother if no medical or obstetrical indication for delivery Strong support from ACOG Now a national quality measure for hospital performance: – National Quality Forum (NQF) – Leapfrog Group – The Joint Commission (TJC)

51. What is the Real Importance Here? There will continue to be research and technology innovations, and changes in best practice that need to be implemented Physician leadership and collaboration with nursing and hospital administration is essential