Preventing Elective Deliveries Before 39 Weeks by n26GQ3

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									    Elimination of Non-Medically
Indicated (Elective) Deliveries Before
     39 Weeks Gestational Age


         John S. Wachtel, M.D. FACOG
Adjunct Clinical Professor, Department of Obstetrics
and Gynecology, Stanford University Medical School
      ACOG District IX Patient Safety Officer
     Program Director, ACOG VRQC Program

                                     November 18, 2011
                  Disclosure Statement

I have no financial interests relevant to this presentation,
but I do serve as an unpaid volunteer on the Executive
Committee of the CMQCC and in several roles for the
March of Dimes.




                                                               2
                       Objectives

1) Describe the increase in non-medically indicated
   (elective) deliveries before 39 weeks and identify the
   contributing factors.

2) Discuss the risks of early term deliveries and the
   benefits of delaying delivery beyond 39 weeks
   gestation.

3) Outline successful initiatives to reduce elective
   deliveries before 39 weeks at hospital, health system
   and statewide levels.



                                                            3
Elimination of Non-Medically Indicated (Elective)
          Deliveries Prior to 39 Weeks



                                    Funding
                             Federal Title V block grant
                              from the California Department
                              of Public Health; Maternal,
                              Child and Adolescent Health
                              Division
                             California Maternal Quality
                              Care Collaborative
                             March of Dimes




                                                           4
                   Acknowledgements
Toolkit Authors:
  Elliott Main, MD
  Bryan Oshiro, MD
  Brenda Chagolla, RN, MSN, CNS
  Debra Bingham, Dr.PH, RN
  Leona Dang-Kilduff, RN, MSN
  Leslie Kowalewski

Author Organizations:
  California Maternal Quality Care Collaborative (CMQCC)
  California Pacific Medical Center
  Loma Linda University School of Medicine
  Catholic Healthcare West
  California Perinatal Quality Care Collaborative (CPQCC)
  March of Dimes
                                                            5
 “Research has shown that early elective
  delivery without medical or obstetrical
indication is linked to neonatal morbidities
  with no benefit to the mother or infant.”




                                               6
 “There are numerous maternal and fetal
indications for deliveries prior to 39 weeks
                 gestation.”




                                               7
 “In addition… this toolkit… is not meant to
imply that elective deliveries after 39 weeks
  have been proven to be without risks for
            mothers and infants.”




                                                8
                                       Terminology


                                   Late Preterm Early Term
      First day of
          LMP



 Week #     0           20 0/7             340/7         37 0/7 39 0/7    416/7


                                     Preterm                      Term       Post term




Modified from Drawing courtesy of William Engle, MD, Indiana University
                                                                                         9
Raju TNK. Pediatrics , 2006;118 1207. Oshiro BT Obstet Gynecol 2009;113:804
    Scheduled Delivery <39 wks in an
       Uncomplicated Pregnancy
   Since 1979, ACOG has cautioned against
    inductions before 39 weeks in the absence of
    a medical indication (Committee Opinion #22)
   ACOG has also noted that “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”.
    (Committee Practice Bulletins #97 and #107)
    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




                                                                                                   11
Source: NCHS, Final Natality Data, Prepared by March of Dimes Perinatal Data Center, April 2006.
Change in Distribution of Births by Gestational Age:
             United States, 1990-2006




                                                                                                         12
   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 non-medically indicated
(elective/planned) deliveries increasing
             in frequency?
               Elective Induction:
            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?

                                                        14
               Clin Obstet Gynecol 2006;49:698-704
                               15
Obstet Gynecol 2009;114:1254
 The Gestational Age that Women
Considered a Baby to be “Full Term”




                                        16
         Obstet Gynecol 2009;114:1254
The Gestational Age that Women
 Considered it “Safe to Deliver”




                                      17
       Obstet Gynecol 2009;114:1254
            Lots of Pressures on
               Obstetricians
   Physician Convenience
       Guarantee attendance at birth
        (“co-dependency”)
       Avoid scheduling conflicts
       Reduce being woken at night
   …what’s the harm?
       Bad outcomes are unrecognized and rare
       The NICU handles these issues just fine
   Limit my risk of a bad pregnancy outcome
   And…payment pressures to deliver own pts
                                 Clin Obstet Gynecol 2006;49:698-704
        “Non-Medical” Excuses for Inductions

   Maternal intolerance to         Suspected fetal
    late pregnancy                   macrosomia
    -   Excess edema,               History of rapid labor/
        backache, indigestion,       lives far away
        insomnia
                                    Possible lower risk for
   Prior labor                      mom or baby
    complication
                                     -   Lower stillbirth rate,
   Prior shoulder dystocia              less macrosomia, less
                                         pre-eclampsia

                                                             19
             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

                                                              20
             Combs et. al. Obstet Gynecol 1993; 81: 492-496
Risks of Non-Medically Indicated
  (Elective) Delivery Before 39
              Weeks
“Better a thousand times careful
        than once dead.”




                         ancient proverb



                                      22
    Complications of Non-Medically Indicated
              (Elective) Deliveries
           Between 37 and 39 Weeks

   Increased NICU admissions
   Increased transient tachypnea of the newborn (TTN)
   Increased respiratory distress syndrome (RDS)
   Increased ventilator support
   Increased suspected or proven sepsis
   Increased newborn feeding problems and other
    transition issues

              See Toolkit for more data and full list of citations    23
      Clark 2009, Madar 1999, Morrison 1995, Sutton 2001, Hook 1997
             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   24
  conditions on newborn morbidity risk. Pediatrics. 2008;121 :e223 –e232
 New Concept: U-Shaped Curve
for near-term Neonatal Outcomes

 Neonatal outcomes at 37 and 38 weeks
  are very similar (or worse) than those at
  41 and 42 weeks…
 Best outcomes are at 39 and 40 weeks!
     NICU Admissions By Weeks Gestation
  Deliveries Without Complications, 2000-2003

          10%

          8%
                     6.66%
                                   NICU Admissions
Percent




          6%

                                                                   3.44%          4.26%
          4%                     3.36%
                                          2.47%       2.65%

          2%

          0%
                37th Week    38th Week   39th Week   40th Week   41st Week   42nd Week
                  (8,001)     (18,988)    (33,185)    (19,601)     (4,505)      (258)
                                          Gestational Weeks



                                                                                          26
                            Oshiro et al. Obstet Gynecol 2009;113:804-811.
          RDS By Weeks Gestation
Deliveries Without Complications, 2000-2003

          2.5%


          2.0%
                      1.92%
                                             RDS
          1.5%
Percent




          1.0%
                                   0.68%                               0.67%        0.78%
                                             0.42%       0.41%
          0.5%


          0.0%
                 37th Week    38th Week   39th Week   40th Week   41st Week    42nd Week
                   (8,001)     (18,988)    (33,185)    (19,601)     (4,505)       (258)
                                           Gestational Weeks


                                                                                            27
                             Oshiro et al. Obstet Gynecol 2009;113:804-811.
              Ventilator Usage By Weeks Gestation
          Deliveries Without Complications, 2000-2003

          2.0%
          1.8%


                                     Ventilator Use
          1.6%
          1.4%
                      1.19%
          1.2%
Percent




          1.0%
          0.8%
                                0.47%                                  0.47%
          0.6%
                                           0.25%        0.30%                       0.39%
          0.4%
          0.2%
          0.0%
                 37th Week    38th Week   39th Week   40th Week   41st Week    42nd Week
                   (8,001)     (18,988)    (33,185)    (19,601)     (4,505)       (258)
                                            Gestational Weeks



                                                                                           28
                               Oshiro et al. Obstet Gynecol 2009;113:804-811.
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 at 38-39 weeks


                                                     29
                 Tita AT, et al, NEJM 2009;360:111
                   Adverse Neonatal Outcomes According to Completed
                      Week of Gestation at Delivery: Absolute Risk

                                                                                                 37+ Weeks
                   16%
                                                                                                 38+ Weeks
                   14%
                                                                                                 39+ Weeks
                   12%
Percent Affected




                   10%

                   8%

                   6%

                   4%

                   2%

                   0%
                           Any adverse           Adverse       RDS     TTN      Admission to   Newborn Sepsis
                         outcome or death      respiratory                         NICU         (suspected or
                                            outcome(overall)                                       proven)




                                                                                                                30
                                                 Tita AT, et al, NEJM 2009;360:111
          Timing of Fetal Brain Development

• Cortex 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.

                                                                            31
 (Huttenloher, 1984; Yakavlev, Lecours, 1967; Schade, 1961; Volpe, 2001).
  Mean IQ Scores in 6 yo Children
  from Healthy Term Pregnancies




13,824 healthy term infants followed for an average of 6.5 years. IQ scores adjusted for
multiple factors including: sex, birthweight for gestational age, maternal height and age at birth,
smoking and drinking during pregnancy, parental marital status, number of children in the
household, parental education and occupation.

                                             Yang et al. Am J Epidemiol 2010;171:399-406
   Cerebral Palsy among Term and
          Postterm Births
                                    CP is 2.3x higher at 37wks
                                    and 1.5x higher at 38 wks
                                    than at 39-41 wks




Norwegian birth cohort of 1,682,441 singleton term births without congenital anomalies followed
for a minimum of 4 years (maximum of 20 years) with identified CP in the National Health
Insurance Registry.
                                                    Moster et al. JAMA 2010;304:976-982.
    Caveats on CNS Outcomes…

 Best outcomes are at 40 weeks.
 Note that these studies are associations
  and can not show NOT causation.
 Nonetheless, the onus is on us to show
  that earlier birth is better…
     Examples of Successful Programs
to Reduce Non-Medically Indicated (Elective)
  Deliveries Before 39 Weeks of Gestation


        Magee Women’s Hospital (Pittsburgh)

            Intermountain Healthcare (Utah)

        Hospital Corporation of America (HCA)

            Ohio State Department of Health


                                                 35
        Magee-Women’s 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, L&D too busy!
   In 2006, a process improvement initiative
    changed the induction scheduling process and
    strictly enforced the guidelines.
   “Elective”: not before 39 weeks and without
    cervical ripening agents if 39+0 to 40+6).

                             Fisch et al Obstet Gynecol 2009;113:797
    Magee Women’s Experience with Guidelines
                                             Baseline     Voluntary   Enforced
                                              3mos          3mos       14mos
                                              2004          2005       2006-7
Deliveries                                     2,139        2,260      10,895
Elective Inductions <39wks (N)                   23           21         30
Elective Inductions <39wks (rate)              11.8%        10.0%       4.3%
(elective inductions <39 / total elective                             (p<0.001)
inductions)

Elective Nullip Inductions (N)                   29           33         87
Elective Nullip Inductions =>C/S (N)             10            5         12
Elective Nullip Inductions =>C/S               35.7%        15.2%      13.8%
(rate)                                                                (p<0.01)

Total Induction Rate                           24.9%        20.1%      16.6%

                                                                             37
                        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 2001: 9 urban facilities participated in a
    process improvement program for elective
    deliveries.
   28% of elective deliveries were occurring before 39
    completed weeks of gestation.

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




                                                             40
        Oshiro, B. et al. Obstet Gynecol 2009;113:804-811.
            Common Themes Noted in
      Intermountain Healthcare’s Experience
   Education provided to obstetricians regarding ACOG
    guidelines, best practice.

   Little change until physicians were held accountable,
    nurses were empowered, and guidelines were
    enforced.

   Medical leadership critical.




                                                                      41
                 Oshiro, B. et al. Obstet Gynecol 2009;113:804-811.
“Reduction in elective delivery at <39 weeks of gestation:
  comparative effectiveness of 3 approaches to change
  and the impact on neonatal intensive care admission
                      and stillbirth”

   HCA: Largest healthcare system in the US with approx
    220,000 births annually.

   Cohort study of 27 pilot hospitals in 2007-2009




                                                                       42
              Clark SL. et al. Am J Obstet Gynecol 2010;203:449.e1-6
                         HCA Study Design

   Self-selected to either:
       Group 1—”Hard stop”, staff refuses to schedule <39 wk elective
        procedures, exceptions through chain of command

       Group 2—”Soft stop”, compliance left to individual physicians,
        cases reviewed in peer review sessions

       Group 3—”Education only”, provision of literature and ACOG
        recommendations

   Careful distinction among “planned” deliveries between
    “indicated” and “elective” deliveries




                                                                         43
                Clark SL. et al. Am J Obstet Gynecol 2010;203:449.e1-6
     HCA Trial of 3 Approaches for
Reduction of Elective Deliveries <39 weeks
               Hard Stop
                            Soft Stop/
                            Peer Rev
                                         Education
                                           Only




                                            P=0.135
                               P=0.025
                  P=0.007




                                                                44
       Clark SL. et al. Am J Obstet Gynecol 2010;203:449.e1-6
           Neonatal Outcomes for HCA Trial

   Stillbirth Rate unchanged:
       2007: 0.69%
       2009: 0.71%
       Not significant

   Term NICU Admissions:
       2007: 8.9%
       2009: 7.5% (decreased 16%)
       P<0.001      RR=0.85
                                             45
              Common Themes
   All started with education provided to
    obstetricians regarding ACOG guidelines and
    best practices.
   Modest change at most, until physicians were
    held accountable, nurses were empowered,
    and guidelines were enforced (“Hard stop”).
   Medical leadership important.
   Timely access to data rates acts as
    motivator.
       Alleviating Obstetricians’ Fears About
                  Delaying Delivery

   Obstetricians in several of these studies voiced
    concerns regarding a potential increase in perinatal
    mortality and maternal morbidity.




                                                           47
Stillbirths Before and After Implementation of
    Guidelines at Intermountain Healthcare




                                                                48
           Oshiro, B. et al. Obstet Gynecol 2009;113:804-811.
     Wouldn’t Keeping Women Pregant Longer
    Increase Their Risk of Adverse Outcomes?

   The experience in Ohio and Utah has shown that
    morbidity remained the same for macrosomia, pre-
    eclampsia and maternal infections.

   Decreases were seen in stillbirth, low apgar scores,
    cesarean section for fetal distress, meconium
    aspiration and postpartum anemia.

                                                       49
                  Summary:
Reasons to Eliminate Non-Medically Indicated
   (Elective) Deliveries Before 39 Weeks

   Reduction of neonatal complications
   No harm to mother if no medical or obstetrical
    indication for delivery
   Now a national quality measure:
    -   National Quality Forum (NQF)
    -   Leapfrog Group
    -   The Joint Commission (TJC)
                                                     50
“Out of this nettle, danger, we pluck this
              flower, safety.”




                          William Shakespeare



                                             51

								
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