Every Week Counts

Lisa M. Hollier, MD, MPH, FACOGChair, District XI

American Congress of Obstetricians and Gynecologists

Objectives

• At the completion of this lecture, the participant will be able to:– Weigh the evidence associated with delivery < 39

weeks– Identify barriers to implementation of new policies

to improve neonatal outcomes by reducing NMI early deliveries

– Describe solutions for common obstacles– Discuss potential consequences for failure of new

programs and policies

Conflicts of Interest

• According to ACCME policy, speakers must disclose all associations with proprietary entities that may have a direct relationship to the subject matter of the lecture. They must also disclose any discussion of unlabeled or unapproved uses of products.– I have no such financial relationships– I will not discuss unlabeled or unapproved uses of

products

Cesarean and Labor Induction Rates-Singletons, 1992 and 2002

Source: NCHS, Final Natality Data, Prepared by March of Dimes Perinatal Data Center, April 2006.

2002 Induction

2002 C-S

1992 C-S

1992 Induction

Early

Ter

m

Rates of Induction of Labor by Race and Hispanic Origin in the U.S.

Martin JA, et al. Births: Final data for 2006. National vital statistics reports; 57(7): NCHS 2009.

Late Preterm Births in the US 1990-2006

Increase in Rates in LPTB by State

MFMU Network Study- NEJM 2009

• Observational cohort including 19 different hospitals and 24,000 patients

• 35.8% of the elective Cesarean deliveries were performed before 39 weeks– infants delivered at 38 weeks had a 1.5x greater

chance of being admitted to NICU– infants delivered at 37 had a 2x greater chance of

being admitted to NICU– gestational age with the lowest risk for neonatal

complications was 40 weeks. Tita ATN et al. NEJM 2009;360:111

Tita ATN et al. NEJM 2009;360:111.

Neonatal Outcomes by Gestational Age at Delivery

Adverse Neonatal Outcomes by Gestational Age at Delivery

Tita ATN et al. NEJM 2009;360:111

0%

2%

4%

6%

8%

10%

12%

14%

16%

Any adverseoutcome or death

Adverserespiratory

outcome(overall)

RDS TTN Admission toNICU

Newborn Sepsis(suspected or

proven)

Perc

ent A

ffec

ted

37+ Weeks

38+ Weeks

39+ Weeks

NICU Admissions By Weeks Gestation Deliveries Without Complications, 2000-2003

2.47% 2.65%3.36% 3.44% 4.26%

6.66%

0%

2%

4%

6%

8%

10%

37th Week(8,001)

38th Week(18,988)

39th Week(33,185)

40th Week(19,601)

41st Week(4,505)

42nd Week(258)

Gestational Weeks

Pe

rce

nt

NICU Admissions

Oshiro et al. Obstet Gynecol 2009;113:804-811.

Infant Mortality Rate by GA among singleton live births 1995- 2006

Reddy U et al. Obstet Gynecol 2011;117:1279-87

Timing of Fetal Brain Development

• Cortex volume increases by 50% between 34 and 40 weeks gestation.

• 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; Adams Chapman, 2008

Copyright © 2011 Obstetrics & Gynecology. Published by Lippincott Williams & Wilkins.

Induction and Cesarean Delivery

14

Vrouenraets FP et al. Obstet Gynecol 2005;105(4):690-697.

Copyright © 2011 Obstetrics & Gynecology. Published by Lippincott Williams & Wilkins.

Induction and Cesarean Delivery

Dilation and Cesarean Delivery Rate

Clark SL et al. Am J Obstet Gynecol 2009;200:156.e1-156.e4.

Implementing a Successful Program

Decision to implement a quality initiative

Recruit appropriate leadership

Develop/revise hospital policy for elective delivery

Active enforcement

of policy

Public Awareness Campaign

Collect and report QI

data

Copyright © 2011 Obstetrics & Gynecology. Published by Lippincott Williams & Wilkins.

Intermountain Health ExperienceRa

te o

f neo

nata

l int

ensi

ve

care

uni

t adm

issi

ons

Oshiro, BT et al. Obstet Gynecol 2009;113(4):804-811.

Copyright © 2011 Obstetrics & Gynecology. Published by Lippincott Williams & Wilkins.

Elective deliveries < 39 wks

20

Oshiro, BT et al. Obstet Gynecol 2009;113(4):804-811.

Stillbirth Rates Before & After

Courtesy of March of Dimes

Magee Women’s Experience

Baseline3 months

2004

Voluntary3 months

2005

Enforced14 months

2006-7Deliveries 2,139 2,260 10,895

Elective Inductions <39 weeks (N)Elective Inductions < 39 weeks (rate)

2311.8%

2110%

304.3%

Total Induction Rate 24.9% 20.1% 16.6%

“Voluntary”: educational program and department recommendations“Enforced”: department standard requiring approval by the Perinatal Committee chair before scheduling non-standard indications for inductions

Fisch et al. Obstet Gynecol 2009:113:797

HCA Experience2007N (%)

2009N (%) P value

Deliveries 17,794 17,221 NA

Deliveries ≥37 wk, n 14,995 14,863 NAPlanned + elective deliveries at 37.0-38.6 wk, n 6562 4349 <.001

Elective deliveries at 37.0-38.6 wk, n (%) 1712(9.6) 746(4.3) <.001

Group 1: 7 hospitals, n/N (%) 320/3886(8.2) 65/3818(1.7) .007

Group 2: 9 hospitals, n/N (%) 403/4797(8.4) 155/4646(3.3) <.025

Group 3: 11 hospitals, n/N (%) 989/9111(10.9) 526/8757(6.0) .135Neonatal intensive care unit admissions at ≥37 wk, n (%) 1328(8.9) 1119(7.5) <.001

Clark SL. et al. Am J Obstet Gynecol 2010;203:449.e1-6

Hard Stop

Soft Stop/Peer Review

Education Only

HCA Experience

Clark SL. et al. Am J Obstet Gynecol 2010;203:449.e1-6

Oklahoma Experience

Oklahoma Experience

Deliveries < 39 wks without Indication

Cesarean Delivery < 39 weeks

Inductions < 39 weeks

Post Intervention Deliveries by Indication and Gestational Age

Deliveries < 39 wks without Indication

Cesarean Delivery < 39 weeks

Inductions < 39 weeks

Oklahoma Experience

• A number of hospitals already low rates of nonmedically indicated early deliveries

• Many hospitals have implemented successful programs

• Some hospitals still have high rates of nonmedically indicated delivery

ACOG Practice Bulletin

Labor also may be induced for logistic reasons, for example, risk of rapid labor, distance from hospital, or psychosocial indications. In such circumstances, at least one of the gestational age criteria in the box should be met, or fetal lung maturity should be established. A mature fetal lung test result before 39 weeks of gestation, in the absence of appropriate clinical circumstances, is not an indication for delivery.

From the Trenches

• That’s not how my babies do• This is an “overly restrictive policy”• It’s really a medical indication• No, really, she’s 39+ weeks• It’s not an induction, it’s an augmentation

That’s not how my babies do• In addition to the authors, the members of the Eunice Kennedy Shriver National Institute of

Child Health and Human Development (NICHD) Maternal–Fetal Medicine Units Network are as follows: Ohio State University — J. Iams, F. Johnson, S. Meadows, H. Walker; University of Alabama at Birmingham — D. Rouse, J. Hauth, A. Northen, S. Tate; University of Texas Southwestern Medical Center — S. Bloom, J. McCampbell, D. Bradford; University of Utah — M. Belfort, F. Porter, B. Oshiro, K. Anderson, A. Guzman; University of Chicago — J. Hibbard, P. Jones, M. Ramos-Brinson, M. Moran, D. Scott; University of Pittsburgh — K. Lain, M. Cotroneo, D. Fischer, M. Luce; Wake Forest University — M. Harper, M. Swain, C. Moorefield, K. Lanier, L. Steele; Thomas Jefferson University — A. Sciscione, M. DiVito, M. Talucci, M. Pollock; Wayne State University — M. Dombrowski, G. Norman, A. Millinder, C. Sudz, B. Steffy; University of Cincinnati — T. Siddiqi, H. How, N. Elder; Columbia University — F. Malone, M. D'Alton, V. Pemberton, V. Carmona, H. Husami; Brown University — H. Silver, J. Tillinghast, D. Catlow, D. Allard; Northwestern University — M. Socol, D. Gradishar, G. Mallett; University of Miami — G. Burkett, J. Gilles, J. Potter, F. Doyle, S. Chandler; University of Tennessee — W. Mabie, R. Ramsey; University of Texas at San Antonio — O. Langer, S. Barker, M. Rodriguez; University of North Carolina — K. Moise, K. Dorman, S. Brody, J. Mitchell; University of Texas at Houston — L. Gilstrap, M. Day, M. Kerr, E. Gildersleeve; Case Western Reserve University — P. Catalano, C. Milluzzi, B. Slivers, C. Santori; George Washington University Biostatistics Center — E. Thom, S. Gilbert, H. Juliussen-Stevenson, M. Fischer; Eunice Kennedy Shriver NICHD — D. McNellis, K. Howell, S. Pagliaro.

That’s not how my babies do

• First, the majority of deliveries occurring between 38 and 39 weeks of gestation do not result in harm.

• The absolute number of newborn respiratory complications is low.

• If an obstetrician performs 200 deliveries a year and 10% of his or her patients are electively delivered at 38 weeks of gestation, only one neonate would be admitted to the NICU per year.

This is an overly restrictive policy

Protocols and strong guidelines are used extensively in Internal Medicine and Surgery Door-to-cath times, use of ASA and β-blockers Pre-operative antibiotics and VTE prevention Stroke: very strict protocols Publicly reported, payment-based standards

OB has been “below the radar” Movement has now been taken up by commercial

insurers and Medicaid

It’s really a medical indication

• Edema• Impending macrosomia

Spong, CY et al; Obstet Gynecol 2011;118:323-333.

Really, she’s 39+ weeks

• Induction not approved due to GA < 39 weeks with no medical indication

• Pregnancy dated by LMP consistent with 10 week CRL

• 34 week ultrasound showed EFW at 75th percentile and CGA was 2 weeks further along– New posting sheet sent with “revised” EDD

It’s not an induction, … augmentation

Quality Marker

• The Joint Commission, CMS, Agency for Healthcare Research and Quality, National Quality Forum, and many insurers have listed NMI early term deliveries as a perinatal quality measure.

How Do You Measure Elective Deliveries <39 weeks?

(The Joint Commission Measure Definition)

TJC (PC-01)v2011A (latest for 2011)

Denominator 37+0 to 38+6 week births without a STANDARD medical or OB

complication

Numerator Inductions and CSNOT in Active Labor or with ROM

Benchmark ?? <5-6%

https://manual.jointcommission.org/bin/view/Manual/WebHome

These are not exhaustive lists!But close… (e.g. prior classical CS)

Caveats about the Indication List

• The Joint Commission list was developed for ease of data collection utilizing ICD-9 codes.

• If there is not an ICD-9 code for an indication, they did not list it (e.g. prior classical CS).

• Everyone understands that there are cases in which earlier delivery is indicated and but the indication is NOT on the list—but these should be uncommon.

• No one is expecting a ZERO rate.• Off-list indications should be prospectively

scrutinized

www.leapfroggroup.org/tooearlydeliveries

HB 1983

• Effective Oct 1, Texas Medicaid will require providers to use CPT modifier for deliveries less than 39 weeks

• Texas Medicaid is be able to recoup payment from hospital and doctor for any NMI deliveries < 39 wks– No time limit– Potential fraud if bill for NMI delivery

Summary

• Reduction of neonatal complications• No harm to mother if no medical or obstetrical

indication for delivery• Strong support from ACOG• Now a national quality measure for hospital

performance:– National Quality Forum (NQF)– Leapfrog Group– The Joint Commission (TJC)

What is the Real Importance Here?

• There will continue to be research and technology innovations, and changes in best practice that need to be implemented

• Physician leadership and collaboration with nursing and hospital administration is essential