Transcript ELECTIVE DELIVERY LESS THAN 39 WEEKS GESTATION

ELECTIVE DELIVERY LESS
THAN 39 WEEKS
GESTATION
Steven Holt, MD, FACOG
Chair Department of OB/GYN
Rose Medical Center
2/10/09
This is not new information
 For over 2 decades, ACOG has advocated
awaiting 39 completed weeks for elective
deliveries with accurate dating criteria.
 We now have good supportive data and
national quality organizations like the
National Quality Forum establishing
measurable standards that organizations
and providers will be held to
 Core Measures in Obstetrics and Pediatrics
are just around the corner
Why Elective Deliveries <39 weeks
 Patient request
1. Premium on having “my Doctor/Midwife”
do my delivery
2. May be for convenience. Easier to arrange
child care, grandma’s arrival to help
3. “ I DO NOT want to go into labor”
4. “ It really isn’t dangerous for my baby, is
it?”
Why Elective Deliveries <39 weeks
 Providers schedule
1. Ob Provider’s have a special relationship
with their patients and want to do their
delivery
2. Easier to schedule with call schedule and
availability in L&D
3. Schedule before go into labor. Lower risk
of scar rupture and would rather not do in
the middle of the night.
4. It really doesn’t have any adverse neonatal
effects “in my experience”
Historical Perspective:
 ACOG Technical Bulletin #10,
November 1999
Confirmation of Term Gestation
 Fetal heart tones have been documented for 20 weeks
by nonelectronic fetoscope or for 30 weeks by doppler.
 It has been 36 weeks since a positive serum or urine
human chorionic gonadotropin pregnancy test was
performed by a reliable laboratory.
 An ultrasound measurement of the crown-rump length,
obtained at 6-12 weeks, supports a gestational age of at
least 39 weeks.
 An ultrasound obtained at 13-20 weeks confirms the
gestational age of at least 39 weeks determined by
clinical history and physical examination.
Historical Perspective:
 Focus on Late Preterm Infants
 NQF Perinatal Care Measure Meetings in
Washington, Spring of 2008
 ACOG Technical Bulletin on Fetal Lung
Maturity, Fall 2008
 Am J Obstet Gynecol, December, 2008 (on
line) “Neonatal and Maternal Outcomes
Associated with Elective Term Delivery”
 New England Journal of Medicine, January,
2009 “Timing of Elective Repeat Cesarean
Delivery at Term and Neonatal Outcomes”
National Quality Forum
 Established in 1999
 President’s Advisory Commission on
Consumer Protection and Quality in the
Health Care Industry
 NQF recommendations “ will be the primary
standards used to measure and report on
the quality and efficiency of healthcare in the
United States.”
National Quality Forum
 Joint Commission, Medicare, Medicaid and
Private Insurers derive their standards from
the NQF endorsed list
 Performance in these areas is being used
and will be used in the future to impact
reimbursement for physicians and hospitals
 First measures were established for public
reporting in Obstetrics and Newborn care in
2003
National Quality Forum
 September 2007 at the request of HCA NQF
launched a new effort to establish additional
voluntary performance measures
 NQF accepted recommendations from
multiple stakeholders to “measure what
makes a difference” with a focus on
outcomes, appropriateness, and
cost/resource use measures, coupled with
quality measures
National Quality Forum
 33 measures were evaluated by the
Perinatal Care Steering Committee
 18 performance measures were accepted
 All NQF measures are fully disclosed
“available for use by any interested parties”
Intellectual Property Owners
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Agency for Healthcare and Research Quality (AHRQ)
Asian Liver Center at Stanford
California Maternity Quality Care Collaborative
CDC
Child Health Corporation of America
Christiana Care Health Services
Council of Women and Infants Specialty Hospitals(CWISH)
HCA
Massachusetts General Hospital
National Perinatal Information Center (NPIC)
Providence St. Vincent Medical Center
Vermont Oxford
NQF National Voluntary Consensus
Standards for Perinatal Care
Performance Measure Specifications
Measure PN-007-07 submitted by HCA- St.
Marks Perinatal Center
Elective Delivery Prior to 39 Completed
Weeks Gestation
The Steering Committee unanimously agreed
that this measure be included as a part of
their recommendations
NQF National Voluntary Consensus
Standards for Perinatal Care
 Numerator = Babies from the denominator
electively delivered prior to 39 completed
weeks gestation
 Denominator = All singletons delivered at >
or equal to 37 completed weeks gestation
 Data Source - Medical Record review
NQF National Voluntary Consensus
Standards for Perinatal Care
 Exclusions: Many of these are referenced in the
ACOG Technical Bulletin #10 November, 1999
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Post-dates (645)
Oligohydramnios (658.0)
Maternal Cardiac Disease (648.8)
Previous Stillbirth (648.5)
Maternal Renal Disease (646.7 & 646.0)
Multiple gestation (652)
Maternal Coagulopathy (656.4)
Ruptured Membranes (649.3)
Acute Fatty Liver of Pregnancy (656.1)
Unspecified Antenatal Hemorrhage (646.2)
IUGR (656.5)
Hypertension (642)
Diabetes (648.0)
Placental Abruption (648.6)
Placenta Previa (641)
Isoimmunization (656.2)
Fetal Demise (657)
Hydramnios (658.1)
Malpresentation (656.1)
HCA 2007 Study
 Hospital Corporation of America –
114 obstetric facilities in 21 states.
 225,000 annual deliveries.
HCA 2007 study
 Population sampled: All deliveries between
May 1, 2007 and July 31, 2007 in 27
facilities in 14 states. (Included three
Virginia hospitals and one Colorado
hospital.)
 Facilities chosen to be representative of
entire population – geographic and delivery
volume.
 Comprehensive data collection for all
women undergoing planned delivery at 37
weeks and 0 days or greater.
Methods
 Planned delivery = patient entered hospital
for delivery admission not in labor, or with
ruptured membranes.
 Planned deliveries = indicated + elective.
 Indicated = any indication noted by the
admitting physician or by the nurse
providing OB care.
 Indications tallied, but not questioned
Methods
Probably more elective deliveries than
claimed because on spurious
indications, there was no questioning
done.
For example: If a patient was listed as
having hypertension, but the admitting
BP was 120/60, the patient was listed as
having a medical reason for the planned
delivery and was not listed in the
“elective” group.
Results
 17,794 deliveries
 14,955 at 37 weeks or greater
 6,562 were planned term deliveries 44% of term deliveries
37% of all deliveries
 4,645 were elective planned term deliveries 71% of
planned term deliveries
 31% of all term deliveries were elective
 16% of all deliveries were elective inductions of labor
 11% of all term deliveries were elective and prior to 39
completed weeks gestation
NICU Admissions following Elective
Delivery
 37.0 – 37.6 weeks: 17.8% 241 deliveries 43 NICU admissions
 38.0 – 38.6 weeks: 8.2% 1471 patients 118 NICU admissions
 > 39 weeks: 4.6%
2933 deliveries 135 NICU admissions
 All differences highly significant (p<0.001)
 2/3 were direct NICU admits, 1/3 were admitted later after initial normal
newborn admission.
– As a note, the delivery provider may not realize the baby went to the NICU
after the initial admission.
 Mean NICU stay for these infants was 4.5 days.
Planned Inductions and C-Section
Rates
60
Nulliparous
Multiparous
Cesarean Section Rate (%)
50
40
30
20
10
0
0
1
2
3
4
5
Cervical Dilatation at the time of Induction (cm)
Conclusions
 11% of all term deliveries are elective and performed prior to 39 weeks
gestation, against longstanding ACOG/AAP recommendations.
 Given the nature of many “indications”, the actual rate is probably
higher.
 Such infants experience significant morbidity.
 For all Planned Inductions, the cesarean delivery rate is directly related
to initial cervical dilatation.
 Elective induction of labor with an unfavorable cervix also increases
the risk of cesarean delivery.
NEJM January 8,2009
Timing of Elective Repeat
Cesarean Delivery at Term and
Neonatal Outcomes
NEJM January 8,2009
 Consecutive patients undergoing Repeat CSections at 19 Centers of the Eunice
Kennedy Shriver NICHHD MFM Units
Network from 1999-2002
 Viable singleton pregnancies without any
recognized indications for delivery before 39
weeks gestation
 Primary outcomes measured composite of
Neonatal Death and several adverse
neonatal outcomes
Primary Adverse Neonatal
Outcomes
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RDS and TTN
Hypoglycemia
Newborn Sepsis
NEC (0)
Hypoxic Ischemic Encephalopathy (0)
CPR or Ventilator in first 24 hours
pH <7.0 5 min APGAR<3
NICU admission
Prolonged Hospitalization 5 days or longer
Neonatal f/u to discharge or 120 days of life
NEJM January 8,2009
 24,077 Repeat C-Sections at term 13,258
were elective
 In addition to the NQF exclusions also
excluded patients in labor or attempted
induction, +HIV, history of myomectomy,
connective tissue disorder, previous
classical, vertical, T, J, or unknown uterine
incision, genital herpes, suspected
macrosomia, major malformations,
chorioamnionitis and 1.7% “other”
Demographics <39 weeks
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Patients tended to be older
Lower BMI at time of delivery
Have Private Insurance
White
Married
Early ultrasound for dating in 1st or 2nd
trimester
Weeks Gestation at Elective CS
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6.3% at 37 completed weeks
29.5% at 38 completed weeks
49.1% at 39 completed weeks
15.1% at 40 weeks
35.8% OF THE ELECTIVE REPEAT CSECTIONS WERE PERFORMED BEFORE
39 WEEKS
Primary Adverse Outcome by GA
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15.3% at 37 weeks
11% at 38 weeks
8.0% at 39 weeks
P values <.01
Similar statistically significant trend for any
individual adverse outcome
 >40 weeks had statistically significant
increased adverse outcome compared to 39
weeks
38 and 4 to 38 and 6
The risk of primary adverse outcome during
the last 3 days of 38 completed weeks was
significantly higher than that for deliveries at
39 completed weeks
Confounders
 IUGR was not an exclusion-results same
when data rerun with <2500g neonates
excluded
 There is a risk of fetal death awaiting 39
weeks-”estimated” at 1 in 1000.
 Commentary “Deliveries that occurred
before 39 weeks of gestation but after
positive results of tests of lung maturity
would not be considered inappropriately
early” NO INFORMATION IN STUDY
REGARDING AMNIO RESULTS
Zanardo, et al. Acta Paediatr 2004
 Retrospective study of 1284 elective CSections RDS rate 25/1000 live births
between 37 and 0 and 38 and 6
 RDS rate after 39 and 0 in this study was
7/1000 a significantly lower incidence
 Neonatal RDS with vaginal deliveries in this
study did not vary (3-4/1000) across these
gestational ages
Fetal Lung Maturity Testing
 ACOG Practice Bulletin Number 97,
September 2008
 “Fetal pulmonary maturity should be
confirmed at less than 39 weeks of gestation
unless fetal maturity can be inferred from
historic criteria”
 Probability of RDS is dependent on both the
fetal lung maturity test result and the
gestational age at which the fetal lung
maturity test was performed
Fetal Lung Maturity
 ACOG Practice Bulletin Number 97,
September 2008
 “ Testing for fetal lung maturity should not be
performed, and is contraindicated, when
delivery is mandated for fetal or maternal
indications. Conversely, 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. RDS, IVH, NEC, and other
complications have been reported in
premature newborns delivered with mature
L/S ratios or the presence of PG”
Fetal Lung Maturity
 Complications from 3rd trimester
amniocentesis for FLM are uncommon with
ultrasound guidance
 562 amnios for FLM resulted in a 0.7%
complication rate PROM, PTL, Abruption
and fetal-maternal hemorrhage-one of each.
None required urgent delivery
 913 amnios for FLM urgent delivery in 6
patients 0.7% 3 FHT problems, one each of
placental bleeding, abruption and uterine
rupture
Indications for Amniocentesis
Technical Bulletin #97, Sept 2008
 Twins at 37 and 0 to 37 and 6 without other
indications for delivery
 Diabetics with poor glycemic control if
delivery is contemplated at <39 completed
weeks
 “It has been suggested” in well controlled
diabetics “rare risk” of RDS at 38 weeks and
amniocentesis not needed- Level III
evidence “expert opinion”
Other Indications for Amniocentesis
or <39 week delivery exclusions
 Expanded list from the NEJM study
including full thickness surgery in the upper
uterine segment, T,J or unknown uterine
incisions
 Other Medical and Surgical conditions
LGMD, HIV, Major Congenital
Malformations, genital herpes
 Logistical reasons-risk of rapid labor,
distance from the hospital or “psychosocial”
indications
? OTHER INDICATIONS
 Advanced cervical dilation
 Footling breech presentation
 Husband leaving for Iraq at 38 weeks and 4
days
 She wants you to do her Section and you
are on vacation at 39 weeks or not on call
 Grandma just bought a plane ticket and has
to go home at 39 completed weeks.
So what do we do
 Ignore national data driven guidelines
 Prohibit the behavior-some institutions are
taking this approach with implementation of
strict Policies
 Don’t forget- Anthem BC/BS and United
Health Care sees the same NICU data we
do and it costs them lots of money.
 What is happening in other HCA Hospitals?
39 Week Elective Deliveries in HCA
Institutions
 Greater than 30 perinatal services have
implemented a policy.
 40 perinatal services are somewhere in the
process of implementation
 Other perinatal services are just beginning
discussions
 Do what works best for your institution, your
practitioners and the safety of your patients
How education can change
behavior
 Results of 2007 non-clinically indicated IOL at less than 39
weeks.
 Actions that impacted results were:
 1. Following data per physician, and notifying physicians
that data would be collected.
 2. Provided education to physicians regarding ACOG
bulletin listing appropriate clinical indicators for IOL at less
than 39 weeks.
 3. Provided education to physicians regarding increased
morbidity, mortality and increased LOS related to the near
term infant.
 4. Provided feedback to department of OB/GYN and
individual physicians regarding data collection results.
How education can change behavior
 First quarter non-clinically indicated IOL <
39 weeks was 29.6% of total IOL
 Second Quarter non-clinically indicated IOL
< 39 weeks was 24.3% of total IOL
 Third Quarter non-clinically indicated IOL <
39 weeks was 21% of total IOL
 Fourth Quarter non-clinically indicated IOL <
39 weeks was 12.6% of total IOL
PEER Review-An Educational
Process at Rose
 Oct, Nov, Dec audit of all “Elective
Deliveries” both inductions and C-Sections
 True “fall outs” reviewed in PEER review
and “educational letters” sent to those
providers along with a copy of recent ACOG
technical Bulletin
Educational Letter
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Dear Dr. Holt,
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Your patient, ____, was electively delivered at between 38 and 39 completed
weeks gestation. This letter is from the OBQI committee and serves as a
reminder that all elective deliveries at this gestational age both Cesarean
Sections and Inductions of labor are being audited by the Committee, This is
based on the recommendations of ACOG, the American Academy of Pediatrics
and the National Quality Forum advising against elective deliveries less then
39 completed weeks gestation due to adverse neonatal outcomes associated
with this practice
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We have decided to provide this information to our OB Providers as an
educational tool for the next 3 months. After this time frame we will begin
assigning Peer Review Levels to all Providers who electively deliver patients at
less then 39 completed weeks gestation. The specific Level assigned will be
determined on a case by case basis. This information will become a part of
your Credentialing File in the Medical Staff Office
Educational Letter Educational
 We would be glad to provide you with data in
support of this practice for you to share with your
patients as you decide timing for elective
deliveries. The Green Journal has had ACOG
Practice Bulletins and articles of support of this
practice this year.
 We appreciate your continued efforts to provide
the best possible quality of care for your OB
patients at Rose Medical Center
 Your OBQI committee
PEER Review-An Educational
Process
 Oct.-1 letter was sent 3 charts reviewed- NQF
reporting 1/283 term singleton deliveries= .35%
 Nov.- 3 letters were sent 20 charts reviewed- NQF
reporting 3/272= 1.1%
 December to be reviewed by QI end of the Month
with letters to be sent. I-3 cases to be reviewed
and 18 charts reviewed 253 qualifying deliveries
 WE ARE DOING VERY WELL AT ROSE
PEER Review-An Educational and
Constructive Approach
 Many centers have chosen to look at <39
week inductions on a case by case basis
 Better to have a group of peers make
determinations than to be “told what to do”
 Is there room for “judgment” and “special
cases” ?
 Amniocentesis appropriate in some cases?
Patient Education is Key
“Why The Last Weeks of Pregnancy Count
 The Colorado March of Dimes has an
excellent patient educational pamphlet that
could be incorporated into patient
information packets in OB practitioners
offices and in prenatal classes
 Laminated Baby Brain pamphlet $1
 6 page color pamphlet $15.50/50
 For ordering 1-800-367-6630 #37-2209-07
Why the Last Weeks of Pregnancy Count
10/08
Patient Education is the Key
 The Colorado Perinatal Care Council is very
interested in having this pamphlet available
to every pregnant patient in our State.
Looking into possible grant funding
 March 25th Round Table Discussion-How to
best Implement this throughout the State of
Colorado
 Do we make our own pamphlet-suggestion
last week from the Rose Perinatal
Development Team
Take Home Message
 Babies electively delivered before 39
completed weeks have statistically
significant greater morbidity particularly if
elective C-Section without labor. Look at
larger numbers to see the difference.
 Amnios are not for everybody. In selective
non-elective cases may help make
decisions about timing of delivery
 Provider and patient behavior does change
with education
 Quality and patient safety is the reason to
wait
Thank you
Steven Holt, MD, FACOG
Chair Department of OB/GYN
Rose Medical Center
References:
 American College of Obstetricians and Gynecologist
Technical Bulletin #10. Induction of Labor. November
1999
 American College of Obstetricians and Gynecologist
Technical Bulleting #97. Fetal Lung Maturity. September
2008
 Clark SL, Belfort MA, Miller DK et al: Neonatal and
Maternal Outcomes associated with elective term delivery.
Am J Obstet Gynecol , January 2009
 Alan TN, Landon Mark, Spong CY et al: NEJM, January
2009 “Timing of Elective Repeat Cesarean Delivery at
Term and Neonatal Outcomes”
 National Quality Forum National Voluntary Consensus
Standards for Perinatal Care 2008