reducing non-medical deliveries before 39 weeks...
TRANSCRIPT
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Reducing Non-Medical Deliveries Before 39 Weeks Gestation
Kenneth E. Brown, MD, MBA, FACOG
Copyright © 2011
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Eliminating Elective Deliveries
Before 39 Weeks
ACOG Practice Bulletin: Clinical management guidelines for obstetrician-gynecologists. 1999; (10). Replaces Technical Bulletin 1995; (217).
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Rate of Induction
• Rate rising nationally
• Wide variation between states
• Wide variation within states
Rayburn WF, Zhang J. Rising rates of labor induction. Obstet
Gynecol. 2002
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Rise in Induction of Labor in US 1990-2006
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Complication Rates, Scheduled Repeat Cesareans by Weeks of Gestation
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Gestational Age That Women Consider it Safe to Deliver
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Advocates for Elimination of Elective Deliveries Before 39 Weeks
• Institute for Healthcare Improvement (IHI) • Joint Commission • March of Dimes • Leapfrog group • State Quality Initiatives (LA, CA, MI, UT, ID,
NY) • Several health plans (Cigna, Wellpoint, United
Healthcare, Blue Cross)
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Institute for Healthcare Improvement (IHI)
Perinatal Bundle - Elective Induction Bundle Composite, Data Collection Tool
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Joint Commission Core Measure
• Measure Set: Perinatal Care(PC)
• Set Measure ID: PC-01
• Performance Measure Name: Elective Delivery
• Description: Patients with elective vaginal deliveries or elective cesarean sections at ≥ 37 and < 39 weeks of gestation
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March of Dimes Toolkit
• Making the Case: A literature review
• Data Collection and Quality Improvement
• Clinician and Patient Education:
http://cmqcc.org/_39_week_toolkit
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The Leapfrog Group
• Target rate for elective deliveries before 39 weeks: 12% in 2010…
• Future goal: 5%
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Leapfrog: Hospital Rates of Early Scheduled Deliveries
You can look up reporting hospital rates in your state by going to
http://www.leapfroggroup.org/tooearlydeliveries
Then click on your state
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Rates of prior to 39 week inductions vary widely (0-67%)
Hospital State Rate
South Miami FL 67%
Cleveland Clinic OH 30%
Brigham and Womens
MA 27%
Cedars Sinai CA 17%
Hospital State Rate
Mayo Clinic MN 12%
Vanderbilt TN 12%
Baylor TX 5%
Henry Ford MI 0.4%
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Hospital City Rate
Baton Rouge General
Baton Rouge, La. 0.0%
Tulane Lakeside Metairie, La. 1.9%
Dauterive New Iberia, La. 5.2%
Lakeview Regional Covington, La. 45.9%
Rapides Regional Alexandria, La. 54.0%
Louisiana Rates
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State Initiatives: the Louisiana Department
of Health & Hospitals
Birth Outcomes Project
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Medical Factors
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Factors in Increased Inductions
1. FDA approved cervical ripeners
2. More locally accepted marginal indications
3. Patient or physician preference
4. Accepted risk of cesarean section
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More Factors in Increased Inductions
5. Physician convenience
6. Litigation concerns
7. A high intervention culture in medicine
Rayburn WF, et al. Ob Gyn July 2002
The Leapfrog Group
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Medical Indications for Elective Delivery
• Placental abruption
• Chorioamnionitis
• Fetal demise
• Gestational Hypertension
• Preeclampsia, eclampsia
• Premature rupture of membranes
• Post term pregnancy
• Maternal medical conditions
• Fetal compromise
ACOG Practice Bulletin No. 55
ACOG Practice Bulletin No. 107
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Contraindications to Elective Vaginal Delivery
• Vasa previa or complete placenta previa
• Transverse fetal lie
• Umbilical cord prolapse
• Previous classical cesarean delivery
• Active genital herpes infection
• Previous myomectomy entering the endometrial cavity
ACOG Practice Bulletin No. 107
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Non-Medical Indications for Elective
Delivery (≥ 39 weeks)
• Risk of rapid labor
• Distance from hospital
• Spousal Tour of Duty
• Psycho-social events
ACOG Practice Bulletin No. 107
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Controversial Indications for Induction of Labor
• Suspected Fetal Macrosomia
• Prior Shoulder Dystocia
• Isolated Oligohydramnios
ACOG Practice Bulletin No. 22
ACOG Practice Bulletin No. 101
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ACOG Criteria for Term Gestation
• Ultrasound dating at <20 weeks supports
gestational age ≥ 39 weeks
• FHT’s documented present for 20 weeks by fetoscope or 30 weeks by Doppler
• 36 weeks since positive serum or urine HCG pregnancy test by a reliable lab
ACOG, Induction of labor, Practice Bulletin
No. 107, Obstet Gyn 2009.
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Determining Gestational Age
• When an elective delivery is contemplated,
the gestational age of the fetus must be determined and confirmed
• Iatrogenic prematurity is unacceptable
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Determining Gestational Age (con’t)
Last Menstrual Period (LMP)
• Known and Documented
• Regular cycles
• Not artificially induced
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Determining Gestational Age (con’t)
Ultrasonography
Best early, 6- 12 weeks
Gestational sac size – unreliable (ectopic?)
Crown-rump length – more precise
Second trimester , 16-20 weeks – accurate estimate, fetal anatomy survey
Preference over LMP
ACOG Practice Bulletin No. 101
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Determining Gestational Age (con’t)
Once established, the gestational dating should not be changed.
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Determining Gestational Age (con’t)
In Vitro Fertilization
Fertilization date same as ovulation date
Or … Age of embryo at transfer
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Determining Gestational Age (con’t)
Fetal Lung Maturity ≠ Fetal Maturity
ACOG Practice Bulletin No. 107
ACOG Practice Bulletin No. 97
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Adverse Outcomes, Maternal
• ↑ risk of cesarean section
• ↑ probability of repeat cesarean section
• ↑ length of labor
• ↑ length of hospital stay
• ↑ risk of hysterectomy
Clark SL et al. Neonatal and maternal outcomes…Am J Obstet Gyncol 2009
Glantz JC Term Labor Induction…Obstet Gynecol 2010
ACOG Practice Bulletin No. 7
Bailit JL et al;. Maternal and neonatal outcomes…Am J Obstet Gyncol 2010
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Adverse Outcomes, Neonatal
• ↑ NICU Admissions
• ↑ incidence of Respiratory Distress syndrome
• ↑ risk of intraventricular hemorrhage
• ↑ risk of necrotizing enterocolitis
ACOG Practice Bulletin No. 97
Bates ED et al. Am J Obstet Gynecol, 2009.
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CNIC Admissions Before & After Womans Hospital, Baton Rouge
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NICU Admits by Week of Gestation, Intermountain Healthcare
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Ventilator Use by Weeks of Gestation, Intermountain
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QI Initiatives to Reduce
Elective Inductions Before 39 Weeks
• Intermountain Healthcare – Utah and Idaho
• Magee-Womens Hospital – Pittsburgh, PA
• Ohio Perinatal Quality Collaborative
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Intermountain QI Project
QI Intervention:
– Multidisciplinary team
– Guidelines adopted
– Physician education
– Data collection
– Patient Education
– Consent Forms
Oshiro BT et al. Decreasing elective deliveries before 39 weeks of
gestation in an integrated health care system. Obstet Gynecol. 2009
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Intermountain QI Project
• Gatekeepers of scheduled admits: department chairs, perinatologists
• Guideline: “Delivery, whether by induction or C-section, should be electively undertaken ONLY after 39 weeks gestation, regardless of fetal lung maturity testing, and after both the mother and fetus have been examined thoroughly … and the patient has given consent”
• Individual and institution rates reported
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% of All Elective Births Occurring Before 39 Weeks (Intermountain)
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Intermountain Stillbirth Data Before & After
0.00%
0.05%
0.10%
0.15%
0.20%
0.25%
0.30%
0.35%
0.40%
0.45%
38 39 40 41 42
1999 - 2000
2001 - 2006
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Magee-Womens Hospital UPMC
Fisch JM et al. Labor induction process improvement: a patient quality of care
initiative. Obstet Gyncol. 2009
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Magee QI Project: Reduction of Induction Rates
0.00%
5.00%
10.00%
15.00%
20.00%
25.00%
30.00%
35.00%
40.00%
Elective Inductions Elective NullipInductions
Total Induction Rate
2004 Baseline
2005 Education
2006-07 Approval
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Ohio Perinatal Quality Collaborative
Iams J, Donovan E. Percent of Ohio births at 36-38 weeks. March of Dimes
Big 5 Data Driven QI webinar, 2009.
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% Scheduled Deliveries 36-38 Weeks without indication
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% births 36-38 weeks induced without indication
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Patient Education, March of Dimes excerpt
Here's why your baby needs 39 weeks:
• Important organs, like the brain, lungs and liver, get all the time they need to develop.
• It will be less likely your baby will have vision and hearing problems after birth.
• Babies need time to gain more weight in the womb. Babies born at a healthy weight have an easier time staying warm than babies born too small.
• Babies do better with feeding . Babies born early sometimes can't suck swallow and stay awake.
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Patient Education Resources
• March of Dimes bilingual booklet “Why the Last Weeks of Pregnancy Count”
• March of Dimes Late Preterm Brain Development Card, www.marchofdimes.com
• Healthy Babies are Worth the Wait® Toolkit for Community Partners www.prematurityprevention.org/professionals.html
• Let Labor Begin on Its Own. www.lamaze.org/
• Thinking About Inducing Your Labor: A Guide for Pregnant Women www.effectivehealthcare.ahrq.gov/
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Clark 2010 Study: 3 Methods
27 HCA hospitals in 14 states
»Hard Stop
»Soft Stop
»No Stop
Clark SL et al. Reduction in elective delivery … Am J
Obstet Gynecol 2010.
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Clark Study Outcomes
• 55% reduction in elective early deliveries (from 9.6% to 4.3%)
• 16% decline in NICU admissions overall
• Stillbirths unchanged
• Hard Stop achieved greatest reduction, then Soft Stop, then No Stop
• 1.7% rate achievable with Hard Stop
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Common Elements of Successful Programs to Reduce the Rates
• Define terms/guidelines
• Multidisciplinary teams, collaborative projects
• Measure baseline, collect data
• Physician buy-in
• Education for staff
• Education tools, consent forms for patients
• “Hard stop” admissions versus voluntary
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Hidden Cost to Healthcare System
1. Over scheduling in labor and delivery
2. Longer time in labor and delivery
3. Increase primary cesarean rate
4. Additional nursing time
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Hidden Costs, continued
5. Longer length of hospital stay
6. Increased risk of downstream morbidity
7. Increased risk of litigation
Rayburn WF et al. Rising rates of labor induction…ACOG Obstet
Gynecol, 2002.
Mello MM et a l. National costs of the medical liability…Health
Affairs 2010.
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Claims Profile: Elective Induction prior to 39 weeks
• Labor induced, baby delivered at 38 weeks 4 days
• Soon after delivery, respiratory distress
• 17 days NICU
• Malpractice claim followed Tex. App.-Austin, 2003, Mauzey vs. Sutliff,125 S.W.3d 71
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Compliance with Clinical Pathways
– Noncompliance with an institution’s OB clinical pathways was over 3 x more common for deliveries associated with malpractice claims than those that were not (43% vs. 12%).
– In 79% of the OB malpractice claims involving noncompliance with pathways, the main allegation in the claim related directly to the departure from the pathway.
-- Ransom SB et. al. Reduced medicolegal risk by compliance
with obstetric clinical pathways. Obstet & Gynecology 2003.
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Guidelines and Pathways/Protocols
Guidelines are guidelines
– Not hard and fast rules
– Not one size fits all
If you depart from established guidelines, document your rationale
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Adverse Outcomes and Claims
Rand Corp. study: adverse patient outcomes and claims rise and fall together
Deliveries before 39 weeks are associated with ↑ rate of adverse events
By reducing these deliveries, both adverse outcomes and claims will decline
Greenberg, MD et al. Is Better Patient Safety Associated with Less
Malpractice Activity? Evidence from California. RAND Corporation, 2010.
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Conclusions
• Evidence is consistent that elective inductions prior to 39 weeks increases risk of harm
• Guidelines well established for decades
• Many stakeholders, many collaborative projects aim to reduce or eliminate non-medically indicated deliveries before 39 weeks
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Conclusions
• Physician buy-in, ownership, leadership
• Physician champions needed