Note: location of logos to be determined Elimination of Non-medically Indicated (Elective) Deliveries Before 39 Weeks Gestation Note: location of logos to be determined

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 state-wide levels. Describe a sample implementation plan for the prevention of elective deliveries before 39 weeks.

Terminology Late Preterm Early Term Preterm Term Post term 20 0/7 First day of LMP Week # 20 0/7 340/7 37 0/7 39 0/7 416/7 Preterm Term Post term With apologies to my neonatal colleagues: Let us look at the definition of late preterm: Term gestation is between 260—294 days Preterm is before that A duration of 17 weeks The last 3 weeks of this period we have been calling late preterm, this I must happened after a workshop at NICHD. Drawing courtesy: William Engle, MD, Indiana University Raju TNK. Pediatrics , 2006;118 1207. Oshiro BT Obstet Gynecol 2009;113:804 * 3

Inductions of Labor Since 1979, ACOG cautions against inductions before 39 wks in the absence of a medical indication. Confirmation of gestational age: Ultrasound before 20 weeks gestation to establish accurate gestational age of the fetus Documentation of fetal heart tones by 30 weeks using Doppler ultrasonography Confirmation that it has been 36 weeks since a positive pregnancy test was obtained

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.

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

Increasing C/S and Labor Induction Rates in the United States Induction of labor in the United States has more than doubled as a proportion of all births, from 9% if 1989 to 21% in 2002,

Cesarean Delivery Rate: United States 32% 23% 21% Hamilton BE, Martin JA, Ventura SJ. Births: Preliminary data for 2007. National vital statistics reports, Web release; vol 57 no 12. Hyattsville, MD: National Center for Health Statistics. Released March 18, 2009.

Rates of Induction of Labor by Race and Hispanic Origin 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.

Why are elective/planned deliveries increasing in frequency?

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? Why has elective deliveries or increased? Most people, both patients and obstetricians are unaware of any harm. And there are definitely perceived benefits for timing the delivery. Clin Obstet Gynecol 2006;49:698-704

Obstet Gynecol 2009;114:1254

The Gestational Age Respondents Considered a Baby Full Term Obstet Gynecol 2009;114:1254

The Gestational Age Respondents Considered it Safe to Deliver Obstet Gynecol 2009;114:1254

“Non-Medical” Reasons for Induction? 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 preeclampsia

What’s in it for me? The Obstetricians Physician convenience Guarantee attendance at birth Avoid potential scheduling conflicts Reduce being woken at night … what’s the harm? Amnesia due to rare occurrence. The NICU can handle it. And… Clin Obstet Gynecol 2006;49:698-704

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 However, some of these assumptions are wrong. Take for example inducing someone for suspected macrosomia. There were more cases of shoulder dystocia and cesarean sections in the induction of labor group. Combs et al: Obstet Gynecol 1993; 81:492-496

Risks of Elective Delivery Before 39 weeks.

Delivery indications at late-preterm gestations and infant morality rates in the U.S. NCHS 2001 birth cohort linked birth/death files of 3,483,496 live singleton births at 34-41 weeks. Categorized by Maternal medical conditions OB complications Major congenital anomalies Isolated spontaneous labor; VD without induction and complications No recorded indication Infant deaths/ live births Reddy et al. Pediatrics 2009;124:234-240

Neonatal and Infant Deaths by Weeks Gestation Reddy et al. Pediatrics 2009;124:234-240

Neonatal and Infant Mortality by Indication Reddy et al. Pediatrics 2009;124:234

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

NICU Admissions A study by Oshiro et al, OG 2009;113;804 showed increasing risk for NICU admits for each week before 39 weeks. Oshiro, B. et al. Decreasing elective deliveries before 39 weeks of gestation in an integrated health care system. Obstet Gynecol, 2009. 113: p. 804-811.

RDS Increased risk for respiratory distress syndrome for each week before 39 weeks. Oshiro, B. et al. Decreasing elective deliveries before 39 weeks of gestation in an integrated health care system. Obstet Gynecol, 2009. 113: p. 804-811.

Ventilator Use And neonates on ventilators for each week before 39 weeks. Oshiro, B. et al. Decreasing elective deliveries before 39 weeks of gestation in an integrated health care system. Obstet Gynecol, 2009. 113: p. 804-811.

13,258 elective repeat cesarean births in 19 centers 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 38-39 week Among a large cohort of women with viable singleton pregnancies who underwent elective repeat cesarean sections, more than a third of deliveries were performed before 39 weeks of gestation As compared with deliveries at or after 39 weeks, deliveries before 39 weeks of gestation - even those during the last 3 days before week 39 - were associated with an increased risk of a composite primary outcome that included neonatal death, respiratory complications, need for mechanical ventilation, treated hypoglycemia, newborn sepsis, and admission to the neonatal intensive care unit Tita AT, et al, NEJM 2009;360:111

Adverse Neonatal Outcomes According to Completed Week of Gestation at Delivery Table 3. Odds Ratios for Adverse Neonatal Outcomes According to Completed Week of Gestation at Delivery. Tita AT, et al, NEJM 2009;360:111

35 weeks 20 weeks 40 weeks Slide Courtesy, Dr. Hannah Kinney, 2006 Golgi drawings: Chan and Armstrong, 2002

Fetal Brain Development Corticol 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).

Examples of Successful Programs to Reduce Elective Deliveries Before 39 week of Gestation Magee Women’s Hospital (Pittsburg) Intermountain Healthcare (Utah) Ohio State Department of Health

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

Magee Women’s Experience with Guidelines 3mos 2004 (baseline) 3mos 2005 (voluntary) 14mos 2006-7 (enforced) Deliveries 2,139 2,260 10,895 Elective Inductions <39wks (N) / Total Elective Inductions (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 Rate 24.9% 20.1% 16.6% Fisch et al Obstet Gynecol 2009;113:797

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

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 of 2001, nine 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: p. 804-811.

% Elective Deliveries <39 Weeks January 1999 – December 2005 Oshiro, B. et al. Obstet Gynecol, 2009. 113: p. 804-811.

Common themes Education provided to obstetricians regarding ACOG guidelines, best practice. Little change until guidelines were enforced. Medical leadership important.

Ohio Perinatal Quality Collaborative Reduce inappropriate scheduled deliveries at 36+1 to 38+6 weeks 20 Maternity hospitals 5,830 scheduled deliveries through July 2009 (47% of the population www.OPQC.net

Births at 360 -386 weeks without documented medical or obstetrical indications Aggregate reportPercent of scheduled deliveries at 360/7-386/7 weeks without medical or obstetric indication documented.Ohio Perinatal Quality Collaborative Writing Committee. A statewide initiative to reduce inappropriate scheduled births. Am J Obstet Gynecol 2010. American Journal of Obstetrics & Gynecology 2010; 202:243.e1-243.e8

Percent of births at 36-38 weeks induced without medical or obstetric indication Percent of births at 36-38 weeks induced without medical or obstetric indicationArrow indicates OPQC startup; dotted line indicates aggregate rate of participants; ______ line indicates the mean rate; - - - - - line indicates control limits of the rate.Ohio Perinatal Quality Collaborative Writing Committee. A statewide initiative to reduce inappropriate scheduled births. Am J Obstet Gynecol 2010. Source: American Journal of Obstetrics & Gynecology 2010; 202:243.e1-243.e8 Copyright © 2010 Mosby, Inc. Terms and Conditions

Alleviating fears Obstetricians voiced concerns regarding a potential increase in perinatal mortality and maternal morbidity.

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

Wouldn’t keeping people pregnant longer increase their risk for adverse outcomes? The experience in Ohio and Utah has shown that morbidity remained the same for macrosomia, preeclampsia, and maternal infections. Decreases were seen in stillbirth, low apgars scores, cesarean section for fetal distress, meconium aspiration and postpartum anemia.

Reasons to Stop Elective Deliveries before 39 Weeks To decrease harming the baby or mother. There is no apparent harm in keeping a mother pregnant beyond 39 weeks if there is no medical or obstetrical indication. National Quality Measures: National Quality Forum (NQF) LeapfrogGroup The Joint Commission (TJC)

Fundamental Issues Identify the list of “approved” indications Have Departmental criteria for making certain diagnoses (e.g. hypertensive complications of pregnancy) Consider second oponions Identify the criteria for establishing Gestational age >39 weeks

ACOG List of Example Indications Abruptio placentae Chorioamnionitis Fetal demise Gestational hypertension Preeclampsia, eclampsia Premature rupture of membranes Postterm pregnancy Maternal medical conditions (eg, diabetes mellitus, renal disease, chronic pulmonary disease, chronic hypertension, antiphospholipid syndrome) Fetal compromise (eg, severe fetal growth restriction, isoimmunization, oligohydramnios) ACOG Practice Bulletin: Induction of Labor. Number 107, August 2009

To be redone…

Confirmation of Term Gestation Ultrasound measurement at less than 20 weeks of gestation supports gestational age of 39 weeks or greater. Fetal heart tones have been documented as present for 30 weeks by Doppler ultrasonography. It has been 36 weeks since a positive serum or urine human chorionic gonadotropin pregnancy test result. ACOG Practice Bulletin: Induction of Labor. Number 107, August 2009

Overview: Critical Elements for Successful Implementation

What do we need to get started? Assess the situation Organize a team Plan an implementation strategy Implement the strategy Track progress

Assess the Situation What is your induction and cesarean section rate? Elective vs indicated Before 39 weeks Assess your scheduling process Who schedules Do you know the EGA and indication at the time of scheduling? Who are the champions and problem children? What is the process for refereeing a case?

Organize a team L&D manager Perinatal QI RN OB Chair, MFM, Neonatologist, pediatrician, nurse midwife Lead scheduler Data analyst/ decision support Key obstetrician leaders

Plan an implementation strategy Develop or revise the scheduling process Establish an appeal process for scheduling conflicts Develop physician, staff, and patient education materials Amend hospital policies and procedures Develop data tracking and reporting system and audit tool Plan kickoff

Implement strategy Convene department and staff meetings to educate physicians and staff Provide educational materials for physicians, staff, and patients Choose start date and begin data collection and reporting on a regular basis

Track progress Use data and audit tools to track the number of elective deliveries <39 weeks Report back to staff and providers on a regular basis Address issues and concerns as soon as possible

Scheduling Process All scheduled deliveries (inductions or cesarean sections) must have the following documented at the time of scheduling: Gestational age. The indication for induction or cesarean section.

Scheduling Process:continued Patients can be scheduled either calling the scheduler or faxing in the request. Elective deliveries including repeat scheduled cesarean sections must be at least 39 weeks gestation based upon ACOG criteria. Any scheduling conflicts will be directed to the OB Chair or Director of L&D for resolution. On going problems that are identified will either be taken care of as soon as possible or discussed at future department meetings. Data will be reported back on a regular basis to inform everyone how the project is going.

What providers can do. Educate your patients and staff about the risks and benefits of delivery before or after 39 weeks. Perform an ultrasound before 20 weeks to confirm gestational age on all your patients. Educate your staff on the new scheduling process. Take a lead on promoting best practice.

Fetal lung maturity testing before 39 weeks and neonatal outcomes Gestational age and Fetal Lung Maturity (FLM) tests are related but independent predictors of fetal maturity. Bates E, Rouse D, Chapman V, Mann ML, Carlo W, Tita A. Am J Obstet Gynecol 201:(6) S17, 2009