ELECTIVE DELIVERY LESS THAN 39 WEEKS GESTATION

1
ELECTIVE DELIVERY LESS THAN 39 WEEKS GESTATION

• Steven Holt, MD, FACOG
• Chair Department of OB/GYN
• Rose Medical Center
• 2/10/09

2
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

3
Why Elective Deliveries lt39 weeks

• Patient request
• Premium on having my Doctor/Midwife do my
  delivery
• May be for convenience. Easier to arrange child
  care, grandmas arrival to help
• I DO NOT want to go into labor
• 4. It really isnt dangerous for my baby, is
  it?

4
Why Elective Deliveries lt39 weeks

• Providers schedule
• Ob Providers have a special relationship with
  their patients and want to do their delivery
• Easier to schedule with call schedule and
  availability in LD
• Schedule before go into labor. Lower risk of scar
  rupture and would rather not do in the middle of
  the night.
• It really doesnt have any adverse neonatal
  effects in my experience

5
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.

6
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

7
National Quality Forum

• Established in 1999
• Presidents 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.

8
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

9
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

10
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

11
Intellectual Property Owners

• 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

12
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

13
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 gt or
  equal to 37 completed weeks gestation
• Data Source - Medical Record review

14
NQF National Voluntary Consensus Standards for
Perinatal Care

• Exclusions Many of these are referenced in the
  ACOG Technical Bulletin 10 November, 1999
• Post-dates (645) IUGR (656.5)
• Oligohydramnios (658.0) Hypertension (642)
• Maternal Cardiac Disease (648.8) Diabetes
  (648.0)
• Previous Stillbirth (648.5) Placental Abruption
  (648.6)
• Maternal Renal Disease (646.7 646.0) Placenta
  Previa (641)
• Multiple gestation (652) Isoimmunization
  (656.2)
• Maternal Coagulopathy (656.4) Fetal Demise (657)
• Ruptured Membranes (649.3) Hydramnios (658.1)
• Acute Fatty Liver of Pregnancy (656.1)
  Malpresentation (656.1)
• Unspecified Antenatal Hemorrhage (646.2)

15
HCA 2007 Study

• Hospital Corporation of America 114 obstetric
  facilities in 21 states.
• 225,000 annual deliveries.

16
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.

17
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

18
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.

19
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

20
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
• gt 39 weeks 4.6 2933 deliveries 135
  NICU admissions
• All differences highly significant (plt0.001)
• 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.

21
Planned Inductions and C-Section Rates
22
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.

23
NEJM January 8,2009

• Timing of Elective Repeat Cesarean Delivery at
  Term and Neonatal Outcomes

24
NEJM January 8,2009

• Consecutive patients undergoing Repeat C-Sections
  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

25
Primary Adverse Neonatal Outcomes

• RDS and TTN
• Hypoglycemia
• Newborn Sepsis
• NEC (0)
• Hypoxic Ischemic Encephalopathy (0)
• CPR or Ventilator in first 24 hours
• pH lt7.0 5 min APGARlt3
• NICU admission
• Prolonged Hospitalization 5 days or longer
• Neonatal f/u to discharge or 120 days of life

26
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

27
Demographics lt39 weeks

• 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

28
Weeks Gestation at Elective CS

• 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 C-SECTIONS WERE
  PERFORMED BEFORE 39 WEEKS

29
Primary Adverse Outcome by GA

• 15.3 at 37 weeks
• 11 at 38 weeks
• 8.0 at 39 weeks
• P values lt.01
• Similar statistically significant trend for any
  individual adverse outcome
• gt40 weeks had statistically significant increased
  adverse outcome compared to 39 weeks

30
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

31
Confounders

• IUGR was not an exclusion-results same when data
  rerun with lt2500g 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

32
Zanardo, et al. Acta Paediatr 2004

• Retrospective study of 1284 elective C-Sections
  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

33
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

34
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

35
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

36
Indications for AmniocentesisTechnical 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 lt39 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

37
Other Indications for Amniocentesis or lt39 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

38
? 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.

39
So what do we do

• Ignore national data driven guidelines
• Prohibit the behavior-some institutions are
  taking this approach with implementation of
  strict Policies
• Dont 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?

40
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

41
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.

42
How education can change behavior

• First quarter non-clinically indicated IOL lt 39
  weeks was 29.6 of total IOL
• Second Quarter non-clinically indicated IOL lt 39
  weeks was 24.3 of total IOL
• Third Quarter non-clinically indicated IOL lt 39
  weeks was 21 of total IOL
• Fourth Quarter non-clinically indicated IOL lt 39
  weeks was 12.6 of total IOL

43
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

44
Educational Letter

• Dear Dr. Holt,
• 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
• 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

45
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

46
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

47
PEER Review-An Educational and Constructive
Approach

• Many centers have chosen to look at lt39 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?

48
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

49
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

50
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

51
Thank you

• Steven Holt, MD, FACOG
• Chair Department of OB/GYN
• Rose Medical Center

52
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
•