The 39 Weeks Project: Eliminating Elective Deliveries Under 39 Weeks’ Gestation The first maternal health initiative of the Perinatal Quality Collaborative of North Carolina

PQCNC 39 Weeks Project GOAL: Eliminate elective delivery <39 weeks without documented fetal lung maturity in participating hospitals Project director – Nancy Chescheir, MD (Perinatologist) Project coordinator – Kate Berrien, RN, MS Expert panel of obstetricians, nurse manager and clinical nurse specialist from hospitals with existing 39 weeks guidelines Partnership with NC March of Dimes 40 participating hospital teams Nurse champion Physician champion Hospital administrator

39 Weeks Project participating hospitals Alamance Regional Medical Center Albemarle Hospital Blue Ridge Regional Hospital Cape Fear Valley Medical Center Carolinas Medical Center Carolinas Medical Center - Lincoln Carolinas Medical Center - NorthEast Carolinas Medical Center - University Carteret General Hospital Catawba Valley Medical Center Central Carolina Hospital Columbus Regional Healthcare System Duke University Hospital Durham Regional Hospital FirstHealth Richmond Memorial Hospital FirstHealth Moore Regional Hospital Forsyth Medical Center Grace Hospital, Blue Ridge Healthcare Halifax Regional Medical Center Iredell Memorial Hospital Lenoir Memorial Hospital Mission Hospital Morehead Memorial Hospital Nash General Hospital New Hanover Regional Medical Center Onslow Memorial Hospital Pitt County Memorial Hospital Presbyterian Hospital Huntersville Randolph Hospital Rex Health Rowan Regional Medical Center Stanly Regional Medical Center The Outer Banks Hospital The Women's Hospital of Greensboro Transylvania Regional Hospital University of North Carolina Hospitals WakeMed Cary Hospital Watauga Medical Center Wilkes Regional Medical Center Wilson Medical Center

39 Weeks Project – Timeline August 2009: Webinar to orient teams to “lookback” data collection (50-chart review) September 2009: Learning session for all teams (38) to review evidence, site-specific data and to develop goals/action plan October 2009: Data collection began, sites beginning to test changes. Two additional teams joined. December 2009: PQCNC annual meeting, half of teams attended and participated in “town meetings.” January 2010: All-team webinar with national speakers March 2010: Regional town meetings August 2010: Final learning session Late Fall 2010: Next maternal health collaborative begins

39 Weeks Project – Data collection Data collected on every induction and scheduled c-section between 36w0d and 38w6d Criteria for establishing gestational age Cervical exam at admission (for inductions) Mode of delivery Maternal complications Newborn complications Respiratory support (anything beyond blow-by O2 in the delivery room) NICU admission Sepsis Meconium aspiration syndrome Transfer out Death Indication(s) for delivery and presence of objective data to support each indication The disclaimer: Please note that we do not endorse all of these as legitimate medical reasons for planned delivery. This list includes items that you may encounter as “indications for delivery.” You may ultimately decide in your hospital’s action plan not to allow some of these without a preceding amniocentesis to confirm gestational age if delivery is planned before 39 weeks. 5

39 Weeks Project – Indications on data collection tool Coagulation defects (thrombophilia, Factor V Ledien anticardiolipin antibodies, antiphospholipid syndrome) HIV/AIDS Venous thromboembolism Isoimmunization Fetal hydrops Fetal anomaly History of prior stillbirth Genital herpes infection – active or prodromal Maternal drug use Oligohydramnios Multiple gestation Prior CS with classical or unknown incision Prior CS with low transverse incision Long distance from hospital Prior precipitous labor Nonvertex presentation Macrosomia Polyhydramnios Previous myomectomy Advanced cervical dilation Elective/social/psychosocial No indication given by provider Other indication (write in):__________________ Non-reactive NST (Check another indication to explain why test was done) BPP ≤ 4 (Check another indication to explain why test was done) Eclampsia HELLP syndrome PPROM Placenta previa with active bleeding Acute placental abruption Fetal demise Chorioamnionitis Chronic hypertension Pregnancy-induced hypertension/Gestational hypertension Preeclampsia Third trimester bleeding IUGR (SGA + oligo and/or abnormal testing) SGA only Chronic placental abruption Placenta previa without current bleeding Diabetes—poor control Diabetes—good control Cholestasis of pregnancy Proteinuric renal disease Lupus Decreased fetal movement 6

Why 39 Weeks? Joint Commission Perinatal Care Core Measures, effective April 2010: Elective delivery < 39 weeks Cesarean section for first-time, low-risk women Use of antenatal steroids Health care-associated blood stream infections Exclusive breastfeeding at hospital discharge NQF-endorsed voluntary consensus standard for hospital care The Leapfrog Group perinatal care measure

C-section rates In 2007 U.S. cesarean rate was 31.8%, a 54% increase since 1996. North Carolina c-section rate was 31.2% in 2007 and 31.3% in 2008. Primary electives, failed inductions in primiparas Role of decline in rate of attempted VBAC 40% of 1.3 million C/S annually in US are repeat

Induction of labor In 1990, 9.5% of all US births started as inductions of labor In 2006, 22.3% of all US births were inductions Rate of increase of medically indicated inductions was lower than overall induction rate increase Elective inductions are approximately 10% of all US deliveries

Fetal Lung Maturity ACOG Practice Bulletin #97, August 2008 Fetal Lung Maturity ACOG Practice Bulletin #107, August 2009 Induction of Labor To prevent iatrogenic prematurity, fetal pulmonary maturity should be confirmed before scheduled delivery at less than 39 weeks of gestation unless fetal maturity can be inferred from any of the following historic criteria: US at < 20 weeks confirms EGA of ≥39 weeks FHT by Doppler >30 weeks or by fetoscope >20 weeks 36 weeks since + pregnancy test This is an update of ACOG bulletin 230 from 1996 also stating scheduled delivery should not occur before 39 weeks without confirmation of fetal lung maturity.

Shift in gestational age at birth, 1990-2005 SOURCE: National Vital Statistics System. Births: preliminary data for 2005. Available at http://www.cdc.gov/nchs/products/pubs/pubd/hestats/prelimbirths05/prelimbirths05.htm.

Timing of Elective Repeat Cesarean Delivery at Term and Neonatal Outcomes Tita ATN, Landon MB, Spong CY, et al. New England Journal of Medicine; 360:111-120. January 2009 Study of 24,077 repeat c-sections at term, 1999-2002 at 19 hospitals 13,258 (55%) were elective repeat c-sections; of these, 35.8% were before 39 weeks gestation (6.3% at 37 weeks, 29.5% at 38 weeks) Looked at neonatal outcomes Primary outcome was a composite of neonatal death, respiratory distress syndrome, TTN, hypoglycemia, sepsis, NICU admission, NEC, hypoxic-ischemic encephalopathy, CPR, ventilator support, arterial pH below 7.0, 5-minute Apgar 3 or below, prolonged hospitalization (5 or more days). The other 45% were either <37 weeks, or were done for medical or obstetric indication: multiple gestation, major malformation, labor/attempted induction (15.5%), hypertensive disorder, diabetes, cardiac disease, hx of myomectomy, renal disease, HIV, connective-tissue disorder, chorioamnionitis, SROM; indications for nonelective cesarean: classical/vertical/T/J/unknown incision, nonreassuring antepartum fetal testing, suspected macrosomia, genital herpes, previa, abruption, nonvertex presentation

Tita et al, NEJM 2009 There was a higher risk among neonates born at 38 and 4-6 days vs. 39 weeks. (51% of pre-39 week elective deliveries were at this age.) The relative risk was 1.21 with CI 1.04-1.40. Patients with fetal lung maturity testing were not able to be separated – another study showed that 22% of early elective c-sections were done without fetal lung maturity testing, so in this study either no one did have lung maturity testing or they did and still had the higher rates of neonatal outcomes at earlier gestational ages Increased morbidity at 41+ weeks, but less than 5% of deliveries in this group.

Tita et al, NEJM 2009 There was a statistically significant higher risk among neonates born at 38w4-6d vs. 39 weeks (51% of pre-39 week elective deliveries were at this EGA). The relative risk was 1.21 with CI 1.04-1.40. Women who delivered before 39 weeks were more likely to be: Older Lower BMI White Privately insured Had 1st or 2nd trimester U/S for dating

Neonatal and maternal outcomes associated with elective term delivery Clark SL, Miller DD, Belfort MA, et al. American Journal of Obstetrics & Gynecology; 200:156.e1-156.e4. February 2009 Prospective observational study in 27 hospitals over 3 months in 2007 (n=17794) Of term (>37 weeks) deliveries, 44% were planned. Of planned term deliveries, 71% were purely elective 16% of all deliveries were elective induction at term; 9.6% of all deliveries were elective at 37-38 weeks, with about equal numbers of inductions and repeat C/S, and 121 primary elective C/S <39 weeks.

37 weeks 38 weeks 39+ weeks ELECTIVE INDUCTIONS 112 678 204 CLARK, FEB 09 AJOG (1) 37 weeks 38 weeks 39+ weeks ELECTIVE INDUCTIONS 112 678 204 NICU ADMISSIONS 17 44 61 % 15.2 * 7.0* 6.0 ELECTIVE PRIMARY CS 24 97 153 5 16 12 20.8* 16.5* 7.8

TOTAL ELECTIVE DELIVERIES 241 1471 2983 CLARK FEB 2009 AJOG (2) 37 weeks 38 weeks 39+ weeks ELECTIVE REPEAT CS 105 696 776 NICU ADMISSION 21 58 62 % 20.0* 8.3 8.0 TOTAL ELECTIVE DELIVERIES 241 1471 2983 NICU ADMISSIONS 43 118 135 17.8* 8.0* 4.6

CS rate by dilation at time of induction Clark et al Among inductions, C-section rate not related to gestational age but highly correlated with cervical dilation for nulliparous and multiparous

Health Care Cost & Utilization Project data from AHRQ: 2003 Increased “throughput” – unclogs labor and delivery and postpartum units. Better outcome for mom/baby dyad? – moms doing 2-3 induction plus c/section are tired and in pain Health Care Cost & Utilization Project data from AHRQ: 2003

The patient’s voice What is driving the increase in scheduled delivery before 39 weeks? Maternal complications Fetal complications Patient request Provider schedules Employment issues Deployment issues Family availability What else?

Women’s Perceptions Regarding the Safety of Births at Various Gestational Ages Goldenberg RL, McClure EM, Bhattacharya A, Groat T, Stahl. Obstetrics & Gynecology, 114: 1254-1258. December 2009. The gestational age respondents consider a baby full term (n=650).

Goldenberg et al, 2009 The gestational age respondents considered it safe to delivery a neonate.

What’s next? 39 Weeks Project ends this summer Focus on “spread” to other NC hospitals and maintenance at those who have decreased rate of electives <39 weeks New initiative for 2011: increasing the rate of vaginal delivery among low-risk, first-time mothers at term (reducing the primary c-section rate)!

Questions? Kate Berrien, RN, BSN, MS UNC Center for Maternal & Infant Health 39 Weeks Project Coordinator, PQCNC Kberrien@unch.unc.edu 919-843-9336 www.pqcnc.org www.mombaby.org