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Elimination of Non-Medically Indicated (Elective) Deliveries Before 39 Weeks Gestational Age

Elimination of Non-Medically Indicated (Elective) Deliveries Before 39 Weeks Gestational Age. John S. Wachtel, M.D. FACOG Adjunct Clinical Professor, Department of Obstetrics and Gynecology, Stanford University Medical School ACOG District IX Patient Safety Officer

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Elimination of Non-Medically Indicated (Elective) Deliveries Before 39 Weeks Gestational Age

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  1. Elimination of Non-Medically Indicated (Elective) Deliveries Before 39 Weeks Gestational Age John S. Wachtel, M.D. FACOG Adjunct Clinical Professor, Department of Obstetrics and Gynecology, Stanford University Medical School ACOG District IX Patient Safety Officer Program Director, ACOG VRQC Program November 18, 2011

  2. Disclosure Statement I have no financial interests relevant to this presentation, but I do serve as an unpaid volunteer on the Executive Committee of the CMQCC and in several roles for the March of Dimes.

  3. Objectives • Describe the increase in non-medically indicated (elective) deliveries before 39 weeks and identify the contributing factors. • Discuss the risks of early term deliveries and the benefits of delaying delivery beyond 39 weeks gestation. • Outline successful initiatives to reduce elective deliveries before 39 weeks at hospital, health system and statewide levels.

  4. Elimination of Non-Medically Indicated (Elective) Deliveries Prior to 39 Weeks • Federal Title V block grant from the California Department of Public Health; Maternal, Child and Adolescent Health Division • California Maternal Quality Care Collaborative • March of Dimes Funding

  5. Acknowledgements 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

  6. “Research has shown that early elective delivery without medical or obstetrical indication is linked to neonatal morbidities with no benefit to the mother or infant.”

  7. “There are numerous maternal and fetal indications for deliveries prior to 39 weeks gestation.”

  8. “In addition… this toolkit… is not meant to imply that elective deliveries after 39 weeks have been proven to be without risks for mothers and infants.”

  9. Terminology Term Late Preterm Early Term First day of LMP 0 20 0/7 340/7 37 0/7 39 0/7 416/7 Week # Preterm Post term Modified from Drawing courtesy of William Engle, MD, Indiana University Raju TNK. Pediatrics , 2006;118 1207. Oshiro BT Obstet Gynecol 2009;113:804

  10. Scheduled Delivery <39 wks in an Uncomplicated Pregnancy • 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)

  11. Early Term U.S. Cesarean Section and Labor Induction Rates Singleton Live Births by Week of Gestation,1992 and 2002 2002 C-S 1992 C-S 2002 Induction 1992 Induction Source: NCHS, Final Natality Data, Prepared by March of Dimes Perinatal Data Center, April 2006.

  12. 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.

  13. Why are non-medically indicated (elective/planned) deliveries increasing in frequency?

  14. Elective Induction:Sounds like a good idea… • Advanced planning • Convenience • Delivered by her doctor • Maternal intolerance to late pregnancy • Excess edema, backache, indigestion, insomnia • Prior bad pregnancy • And, it’s okay right? Clin Obstet Gynecol 2006;49:698-704

  15. Obstet Gynecol 2009;114:1254

  16. The Gestational Age that Women Considered a Baby to be “Full Term” Obstet Gynecol 2009;114:1254

  17. The Gestational Age that Women Considered it “Safe to Deliver” Obstet Gynecol 2009;114:1254

  18. Lots of Pressures onObstetricians • Physician Convenience • Guarantee attendance at birth(“co-dependency”) • Avoid scheduling conflicts • Reduce being woken at night • …what’s the harm? • Bad outcomes are unrecognized and rare • The NICU handles these issues just fine • Limit my risk of a bad pregnancy outcome • And…payment pressures to deliver own pts Clin Obstet Gynecol 2006;49:698-704

  19. Maternal intolerance to late pregnancy Excess edema, backache, indigestion, insomnia Prior labor complication Prior shoulder dystocia Suspected fetal macrosomia History of rapid labor/ lives far away Possible lower risk for mom or baby Lower stillbirth rate, less macrosomia, less pre-eclampsia “Non-Medical” Excuses for Inductions

  20. Suspected Fetal Macrosomia(Non-Diabetic Population) • Does not reduce risk of shoulder dystocia • Doubles risk of cesarean delivery • 262 pregnancies EFW >90% • Elective group: • 57% cesarean delivery rate • 5.3% shoulder dystocia • Spontaneous labor group: • 31% cesarean delivery rate • 2.5% shoulder dystocia Combs et. al. Obstet Gynecol 1993; 81: 492-496

  21. Risks of Non-Medically Indicated (Elective) Delivery Before 39 Weeks

  22. “Better a thousand times careful than once dead.” ancient proverb

  23. Complications of Non-Medically Indicated (Elective) Deliveries Between 37 and 39 Weeks • 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 See Toolkit for more data and full list of citations Clark 2009, Madar 1999, Morrison 1995, Sutton 2001, Hook 1997

  24. 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

  25. New Concept: U-Shaped Curve for near-term Neonatal Outcomes • 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!

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

  27. RDS By Weeks GestationDeliveries Without Complications, 2000-2003 RDS Oshiro et al. Obstet Gynecol 2009;113:804-811.

  28. Ventilator Usage By Weeks GestationDeliveries Without Complications, 2000-2003 Ventilator Use Oshiro et al. Obstet Gynecol 2009;113:804-811.

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

  30. Adverse Neonatal Outcomes According to Completed Week of Gestation at Delivery: Absolute Risk Tita AT, et al, NEJM 2009;360:111

  31. 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 myelinatedwhite 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).

  32. Mean IQ Scores in 6 yo Children from Healthy Term Pregnancies 13,824 healthy term infants followed for an average of 6.5 years. IQ scores adjusted for multiple factors including: sex, birthweight for gestational age, maternal height and age at birth, smoking and drinking during pregnancy, parental marital status, number of children in the household, parental education and occupation. Yang et al. Am J Epidemiol 2010;171:399-406

  33. Cerebral Palsy among Term and Postterm Births CP is 2.3x higher at 37wks and 1.5x higher at 38 wks than at 39-41 wks 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 CP in the National Health Insurance Registry. Moster et al. JAMA 2010;304:976-982.

  34. Caveats on CNS Outcomes… • Best outcomes are at 40 weeks. • Note that these studies are associations and can not show NOT causation. • Nonetheless, the onus is on us to show that earlier birth is better…

  35. Examples of Successful Programs to Reduce Non-Medically Indicated (Elective) Deliveries Before 39 Weeks of Gestation • Magee Women’s Hospital (Pittsburgh) • Intermountain Healthcare (Utah) • Hospital Corporation of America (HCA) • Ohio State Department of Health

  36. Magee-Women’s 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, L&D too busy! • In 2006, a process improvement initiative changed the induction scheduling process and strictly enforced the guidelines. • “Elective”: not before 39 weeks and without cervical ripening agents if 39+0 to 40+6). Fisch et al Obstet Gynecol 2009;113:797

  37. Magee Women’s Experience with Guidelines Fisch et al Obstet Gynecol 2009;113:797

  38. Magee Women’s 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

  39. 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.

  40. % Non-Medically Indicated Deliveries<39 Weeks, January 1999 – December 2005 Oshiro, B. et al. Obstet Gynecol 2009;113:804-811.

  41. Common Themes Noted inIntermountain Healthcare’s Experience • Education provided to obstetricians regarding ACOG guidelines, best practice. • Little change until physicians were held accountable, nurses were empowered, and guidelines were enforced. • Medical leadership critical. Oshiro, B. et al. Obstet Gynecol 2009;113:804-811.

  42. “Reduction in elective delivery at <39 weeks of gestation: comparative effectiveness of 3 approaches to change and the impact on neonatal intensive care admission and stillbirth” • HCA: Largest healthcare system in the US with approx 220,000 births annually. • Cohort study of 27 pilot hospitals in 2007-2009 Clark SL. et al. Am J Obstet Gynecol 2010;203:449.e1-6

  43. HCA Study Design • Self-selected to either: • Group 1—”Hard stop”, staff refuses to schedule <39 wk elective procedures, exceptions through chain of command • Group 2—”Soft stop”, compliance left to individual physicians, cases reviewed in peer review sessions • Group 3—”Education only”, provision of literature and ACOG recommendations • Careful distinction among “planned” deliveries between “indicated” and “elective” deliveries Clark SL. et al. Am J Obstet Gynecol 2010;203:449.e1-6

  44. HCA Trial of 3 Approaches for Reduction of Elective Deliveries <39 weeks Hard Stop Soft Stop/Peer Rev EducationOnly P=0.135 P=0.025 P=0.007 Clark SL. et al. Am J Obstet Gynecol 2010;203:449.e1-6

  45. Neonatal Outcomes for HCA Trial • Stillbirth Rate unchanged: • 2007: 0.69% • 2009: 0.71% • Not significant • Term NICU Admissions: • 2007: 8.9% • 2009: 7.5% (decreased 16%) • P<0.001 RR=0.85

  46. Common Themes • All started with education provided to obstetricians regarding ACOG guidelines and best practices. • Modest change at most, until physicians were held accountable, nurses were empowered, and guidelines were enforced (“Hard stop”). • Medical leadership important. • Timely access to data rates acts as motivator.

  47. Alleviating Obstetricians’ Fears About Delaying Delivery • Obstetricians in several of these studies voiced concerns regarding a potential increase in perinatal mortality and maternal morbidity.

  48. Stillbirths Before and After Implementation of Guidelines at Intermountain Healthcare Oshiro, B. et al. Obstet Gynecol 2009;113:804-811.

  49. Wouldn’t Keeping Women Pregant Longer Increase Their Risk of Adverse Outcomes? • The experience in Ohio and Utah has shown that morbidity remained the same for macrosomia, pre-eclampsia and maternal infections. • Decreases were seen in stillbirth, low apgar scores, cesarean section for fetal distress, meconium aspiration and postpartum anemia.

  50. 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)

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