ELECTIVE DELIVERY LESS THAN 39 WEEKS GESTATION

1. ELECTIVE DELIVERY LESS THAN 39 WEEKS GESTATION Steven Holt, MD, FACOG Chair Department of OB/GYN Rose Medical Center 2/10/09

2. This is not new information • For over 2 decades, ACOG has advocated awaiting 39 completed weeks for elective deliveries with accurate dating criteria. • We now have good supportive data and national quality organizations like the National Quality Forum establishing measurable standards that organizations and providers will be held to • Core Measures in Obstetrics and Pediatrics are just around the corner

3. Why Elective Deliveries <39 weeks • Patient request • Premium on having “my Doctor/Midwife” do my delivery • May be for convenience. Easier to arrange child care, grandma’s arrival to help • “ I DO NOT want to go into labor” 4. “ It really isn’t dangerous for my baby, is it?”

4. Why Elective Deliveries <39 weeks • Providers schedule • Ob Provider’s have a special relationship with their patients and want to do their delivery • Easier to schedule with call schedule and availability in L&D • Schedule before go into labor. Lower risk of scar rupture and would rather not do in the middle of the night. • It really doesn’t have any adverse neonatal effects “in my experience”

5. Historical Perspective: ACOG Technical Bulletin #10, November 1999 Confirmation of Term Gestation Fetal heart tones have been documented for 20 weeks by nonelectronic fetoscope or for 30 weeks by doppler. It has been 36 weeks since a positive serum or urine human chorionic gonadotropin pregnancy test was performed by a reliable laboratory. An ultrasound measurement of the crown-rump length, obtained at 6-12 weeks, supports a gestational age of at least 39 weeks. An ultrasound obtained at 13-20 weeks confirms the gestational age of at least 39 weeks determined by clinical history and physical examination.

6. Historical Perspective: Focus on Late Preterm Infants NQF Perinatal Care Measure Meetings in Washington, Spring of 2008 ACOG Technical Bulletin on Fetal Lung Maturity, Fall 2008 Am J Obstet Gynecol, December, 2008 (on line) “Neonatal and Maternal Outcomes Associated with Elective Term Delivery” New England Journal of Medicine, January, 2009 “Timing of Elective Repeat Cesarean Delivery at Term and Neonatal Outcomes”

7. National Quality Forum • Established in 1999 • President’s Advisory Commission on Consumer Protection and Quality in the Health Care Industry • NQF recommendations “ will be the primary standards used to measure and report on the quality and efficiency of healthcare in the United States.”

8. National Quality Forum • Joint Commission, Medicare, Medicaid and Private Insurers derive their standards from the NQF endorsed list • Performance in these areas is being used and will be used in the future to impact reimbursement for physicians and hospitals • First measures were established for public reporting in Obstetrics and Newborn care in 2003

9. National Quality Forum • September 2007 at the request of HCA NQF launched a new effort to establish additional voluntary performance measures • NQF accepted recommendations from multiple stakeholders to “measure what makes a difference” with a focus on outcomes, appropriateness, and cost/resource use measures, coupled with quality measures

10. National Quality Forum • 33 measures were evaluated by the Perinatal Care Steering Committee • 18 performance measures were accepted • All NQF measures are fully disclosed “available for use by any interested parties”

11. Intellectual Property Owners • Agency for Healthcare and Research Quality (AHRQ) • Asian Liver Center at Stanford • California Maternity Quality Care Collaborative • CDC • Child Health Corporation of America • Christiana Care Health Services • Council of Women and Infants Specialty Hospitals(CWISH) • HCA • Massachusetts General Hospital • National Perinatal Information Center (NPIC) • Providence St. Vincent Medical Center • Vermont Oxford

12. NQF National Voluntary Consensus Standards for Perinatal Care Performance Measure Specifications Measure PN-007-07 submitted by HCA- St. Marks Perinatal Center Elective Delivery Prior to 39 Completed Weeks Gestation The Steering Committee unanimously agreed that this measure be included as a part of their recommendations

13. NQF National Voluntary Consensus Standards for Perinatal Care • Numerator = Babies from the denominator electively delivered prior to 39 completed weeks gestation • Denominator = All singletons delivered at > or equal to 37 completed weeks gestation • Data Source - Medical Record review

14. NQF National Voluntary Consensus Standards for Perinatal Care Exclusions: Many of these are referenced in the ACOG Technical Bulletin #10 November, 1999 Post-dates (645) IUGR (656.5) Oligohydramnios (658.0) Hypertension (642) Maternal Cardiac Disease (648.8) Diabetes (648.0) Previous Stillbirth (648.5) Placental Abruption (648.6) Maternal Renal Disease (646.7 & 646.0) Placenta Previa (641) Multiple gestation (652) Isoimmunization (656.2) Maternal Coagulopathy (656.4) Fetal Demise (657) Ruptured Membranes (649.3) Hydramnios (658.1) Acute Fatty Liver of Pregnancy (656.1) Malpresentation (656.1) Unspecified Antenatal Hemorrhage (646.2)

15. HCA 2007 Study • Hospital Corporation of America – 114 obstetric facilities in 21 states. • 225,000 annual deliveries.

16. HCA 2007 study • Population sampled: All deliveries between May 1, 2007 and July 31, 2007 in 27 facilities in 14 states. (Included three Virginia hospitals and one Colorado hospital.) • Facilities chosen to be representative of entire population – geographic and delivery volume. • Comprehensive data collection for all women undergoing planned delivery at 37 weeks and 0 days or greater.

17. Methods • Planned delivery = patient entered hospital for delivery admission not in labor, or with ruptured membranes. • Planned deliveries = indicated + elective. • Indicated = any indication noted by the admitting physician or by the nurse providing OB care. • Indications tallied, but not questioned

18. Methods Probably more elective deliveries than claimed because on spurious indications, there was no questioning done. For example: If a patient was listed as having hypertension, but the admitting BP was 120/60, the patient was listed as having a medical reason for the planned delivery and was not listed in the “elective” group.

19. Results • 17,794 deliveries • 14,955 at 37 weeks or greater • 6,562 were planned term deliveries 44% of term deliveries 37% of all deliveries • 4,645 were elective planned term deliveries 71% of planned term deliveries • 31% of all term deliveries were elective • 16% of all deliveries were elective inductions of labor • 11% of all term deliveries were elective and prior to 39 completed weeks gestation

20. NICU Admissions following Elective Delivery • 37.0 – 37.6 weeks: 17.8% 241 deliveries 43 NICU admissions • 38.0 – 38.6 weeks: 8.2% 1471 patients 118 NICU admissions • > 39 weeks: 4.6% 2933 deliveries 135 NICU admissions • All differences highly significant (p<0.001) • 2/3 were direct NICU admits, 1/3 were admitted later after initial normal newborn admission. • As a note, the delivery provider may not realize the baby went to the NICU after the initial admission. • Mean NICU stay for these infants was 4.5 days.

21. Planned Inductions and C-Section Rates

22. Conclusions • 11% of all term deliveries are elective and performed prior to 39 weeks gestation, against longstanding ACOG/AAP recommendations. • Given the nature of many “indications”, the actual rate is probably higher. • Such infants experience significant morbidity. • For all Planned Inductions, the cesarean delivery rate is directly related to initial cervical dilatation. • Elective induction of labor with an unfavorable cervix also increases the risk of cesarean delivery.

23. NEJM January 8,2009 Timing of Elective Repeat Cesarean Delivery at Term and Neonatal Outcomes

24. NEJM January 8,2009 • Consecutive patients undergoing Repeat C-Sections at 19 Centers of the Eunice Kennedy Shriver NICHHD MFM Units Network from 1999-2002 • Viable singleton pregnancies without any recognized indications for delivery before 39 weeks gestation • Primary outcomes measured composite of Neonatal Death and several adverse neonatal outcomes

25. Primary Adverse Neonatal Outcomes • RDS and TTN • Hypoglycemia • Newborn Sepsis • NEC (0) • Hypoxic Ischemic Encephalopathy (0) • CPR or Ventilator in first 24 hours • pH <7.0 5 min APGAR<3 • NICU admission • Prolonged Hospitalization 5 days or longer • Neonatal f/u to discharge or 120 days of life

26. NEJM January 8,2009 • 24,077 Repeat C-Sections at term 13,258 were elective • In addition to the NQF exclusions also excluded patients in labor or attempted induction, +HIV, history of myomectomy, connective tissue disorder, previous classical, vertical, T, J, or unknown uterine incision, genital herpes, suspected macrosomia, major malformations, chorioamnionitis and 1.7% “other”

27. Demographics <39 weeks • Patients tended to be older • Lower BMI at time of delivery • Have Private Insurance • White • Married • Early ultrasound for dating in 1st or 2nd trimester

28. Weeks Gestation at Elective CS • 6.3% at 37 completed weeks • 29.5% at 38 completed weeks • 49.1% at 39 completed weeks • 15.1% at 40 weeks • 35.8% OF THE ELECTIVE REPEAT C-SECTIONS WERE PERFORMED BEFORE 39 WEEKS

29. Primary Adverse Outcome by GA • 15.3% at 37 weeks • 11% at 38 weeks • 8.0% at 39 weeks • P values <.01 • Similar statistically significant trend for any individual adverse outcome • >40 weeks had statistically significant increased adverse outcome compared to 39 weeks

30. 38 and 4 to 38 and 6 The risk of primary adverse outcome during the last 3 days of 38 completed weeks was significantly higher than that for deliveries at 39 completed weeks

31. Confounders • IUGR was not an exclusion-results same when data rerun with <2500g neonates excluded • There is a risk of fetal death awaiting 39 weeks-”estimated” at 1 in 1000. • Commentary “Deliveries that occurred before 39 weeks of gestation but after positive results of tests of lung maturity would not be considered inappropriately early” NO INFORMATION IN STUDY REGARDING AMNIO RESULTS

32. Zanardo, et al. Acta Paediatr 2004 • Retrospective study of 1284 elective C-Sections RDS rate 25/1000 live births between 37 and 0 and 38 and 6 • RDS rate after 39 and 0 in this study was 7/1000 a significantly lower incidence • Neonatal RDS with vaginal deliveries in this study did not vary (3-4/1000) across these gestational ages

33. Fetal Lung Maturity Testing • ACOG Practice Bulletin Number 97, September 2008 • “Fetal pulmonary maturity should be confirmed at less than 39 weeks of gestation unless fetal maturity can be inferred from historic criteria” • Probability of RDS is dependent on both the fetal lung maturity test result and the gestational age at which the fetal lung maturity test was performed

34. Fetal Lung Maturity • ACOG Practice Bulletin Number 97, September 2008 • “ Testing for fetal lung maturity should not be performed, and is contraindicated, when delivery is mandated for fetal or maternal indications. Conversely, 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. RDS, IVH, NEC, and other complications have been reported in premature newborns delivered with mature L/S ratios or the presence of PG”

35. Fetal Lung Maturity • Complications from 3rd trimester amniocentesis for FLM are uncommon with ultrasound guidance • 562 amnios for FLM resulted in a 0.7% complication rate PROM, PTL, Abruption and fetal-maternal hemorrhage-one of each. None required urgent delivery • 913 amnios for FLM urgent delivery in 6 patients 0.7% 3 FHT problems, one each of placental bleeding, abruption and uterine rupture

36. Indications for AmniocentesisTechnical Bulletin #97, Sept 2008 • Twins at 37 and 0 to 37 and 6 without other indications for delivery • Diabetics with poor glycemic control if delivery is contemplated at <39 completed weeks • “It has been suggested” in well controlled diabetics “rare risk” of RDS at 38 weeks and amniocentesis not needed- Level III evidence “expert opinion”

37. Other Indications for Amniocentesis or <39 week delivery exclusions • Expanded list from the NEJM study including full thickness surgery in the upper uterine segment, T,J or unknown uterine incisions • Other Medical and Surgical conditions LGMD, HIV, Major Congenital Malformations, genital herpes • Logistical reasons-risk of rapid labor, distance from the hospital or “psychosocial” indications

38. ? OTHER INDICATIONS • Advanced cervical dilation • Footling breech presentation • Husband leaving for Iraq at 38 weeks and 4 days • She wants you to do her Section and you are on vacation at 39 weeks or not on call • Grandma just bought a plane ticket and has to go home at 39 completed weeks.

39. So what do we do • Ignore national data driven guidelines • Prohibit the behavior-some institutions are taking this approach with implementation of strict Policies • Don’t forget- Anthem BC/BS and United Health Care sees the same NICU data we do and it costs them lots of money. • What is happening in other HCA Hospitals?

40. 39 Week Elective Deliveries in HCA Institutions Greater than 30 perinatal services have implemented a policy. 40 perinatal services are somewhere in the process of implementation Other perinatal services are just beginning discussions Do what works best for your institution, your practitioners and the safety of your patients

41. How education can change behavior • Results of 2007 non-clinically indicated IOL at less than 39 weeks. • Actions that impacted results were: • 1. Following data per physician, and notifying physicians that data would be collected. • 2. Provided education to physicians regarding ACOG bulletin listing appropriate clinical indicators for IOL at less than 39 weeks. • 3. Provided education to physicians regarding increased morbidity, mortality and increased LOS related to the near term infant. • 4. Provided feedback to department of OB/GYN and individual physicians regarding data collection results.

42. How education can change behavior • First quarter non-clinically indicated IOL < 39 weeks was 29.6% of total IOL • Second Quarter non-clinically indicated IOL < 39 weeks was 24.3% of total IOL • Third Quarter non-clinically indicated IOL < 39 weeks was 21% of total IOL • Fourth Quarter non-clinically indicated IOL < 39 weeks was 12.6% of total IOL

43. PEER Review-An Educational Process at Rose • Oct, Nov, Dec audit of all “Elective Deliveries” both inductions and C-Sections • True “fall outs” reviewed in PEER review and “educational letters” sent to those providers along with a copy of recent ACOG technical Bulletin

44. Educational Letter Dear Dr. Holt, Your patient, ____, was electively delivered at between 38 and 39 completed weeks gestation. This letter is from the OBQI committee and serves as a reminder that all elective deliveries at this gestational age both Cesarean Sections and Inductions of labor are being audited by the Committee, This is based on the recommendations of ACOG, the American Academy of Pediatrics and the National Quality Forum advising against elective deliveries less then 39 completed weeks gestation due to adverse neonatal outcomes associated with this practice We have decided to provide this information to our OB Providers as an educational tool for the next 3 months. After this time frame we will begin assigning Peer Review Levels to all Providers who electively deliver patients at less then 39 completed weeks gestation. The specific Level assigned will be determined on a case by case basis. This information will become a part of your Credentialing File in the Medical Staff Office

45. Educational Letter Educational We would be glad to provide you with data in support of this practice for you to share with your patients as you decide timing for elective deliveries. The Green Journal has had ACOG Practice Bulletins and articles of support of this practice this year. We appreciate your continued efforts to provide the best possible quality of care for your OB patients at Rose Medical Center Your OBQI committee

46. PEER Review-An Educational Process Oct.-1 letter was sent 3 charts reviewed- NQF reporting 1/283 term singleton deliveries= .35% Nov.- 3 letters were sent 20 charts reviewed- NQF reporting 3/272= 1.1% December to be reviewed by QI end of the Month with letters to be sent. I-3 cases to be reviewed and 18 charts reviewed 253 qualifying deliveries WE ARE DOING VERY WELL AT ROSE

47. PEER Review-An Educational and Constructive Approach • Many centers have chosen to look at <39 week inductions on a case by case basis • Better to have a group of peers make determinations than to be “told what to do” • Is there room for “judgment” and “special cases” ? • Amniocentesis appropriate in some cases?

48. Patient Education is Key “Why The Last Weeks of Pregnancy Count • The Colorado March of Dimes has an excellent patient educational pamphlet that could be incorporated into patient information packets in OB practitioners offices and in prenatal classes • Laminated Baby Brain pamphlet $1 • 6 page color pamphlet $15.50/50 • For ordering 1-800-367-6630 #37-2209-07 Why the Last Weeks of Pregnancy Count 10/08

49. Patient Education is the Key • The Colorado Perinatal Care Council is very interested in having this pamphlet available to every pregnant patient in our State. Looking into possible grant funding • March 25th Round Table Discussion-How to best Implement this throughout the State of Colorado • Do we make our own pamphlet-suggestion last week from the Rose Perinatal Development Team

50. Take Home Message • Babies electively delivered before 39 completed weeks have statistically significant greater morbidity particularly if elective C-Section without labor. Look at larger numbers to see the difference. • Amnios are not for everybody. In selective non-elective cases may help make decisions about timing of delivery • Provider and patient behavior does change with education • Quality and patient safety is the reason to wait