VBAC Is There Such a Thing as Low Risk

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VBACIs There Such a Thing as Low Risk?

• Michele R. Lauria, MD
• Associate Professor
• Departments of Ob/Gyn and Radiology
• Dartmouth Hitchcock Medical Center
• Medical Director NNEPQIN

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Objectives

• Risk factors associated with uterine rupture
• Risks of ERCS vs TOL
• How did the VBAC controversy start?
• Social/Economic Impact of VBAC Decline
• An Evidence Based Approach
• The VT/NH VBAC Project

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History of Availability

• 1980s 30 minute rule
• ACOG, ASA, AAP
• Cesarean delivery personnel onsite within 30
  minutes of the decision
• 1990 JCAHO adopts 30 minute rule
• 1990s Managed care mandated TOL
• 1999 ACOG Practice Bulletin immediately
  available
• 2000 Local Definition ACOG ASA
• 2001 JCAHO adopts same language
• 2001 Lyndon Rochelle
• 2002 VBAC services start closing

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ACOG 2000

• VBAC is an elective procedure
• in institutions equipped to respond to
  emergencies with physicians immediately available
  to provide emergency care.
• ... definition of immediately available personnel
  and facilities remains a local decision based on
  each institutions available resources and
  geographic location.

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Incorrect PremisesMy Opinion

• VBAC is an elective procedure
• Birth is not elective
• VBAC is a choice
• ACOG UR rate is at least 1
• Most studies over estimate due to poor ICD-9
  codes
• Treat all VBAC equal
• Elective Repeat Cesarean Section is safer
• Increased respiratory complications ERCS vs VBAC
• Law Suit ? Poor care or adverse outcome

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ACOG and the American Society of
Anesthesiologists 2001

• Availability of anesthesia and surgical
  personnel to permit the start of a cesarean
  delivery within 30 minutes of the decision to
  perform the procedure in cases of vaginal birth
  after cesarean delivery (VBAC), appropriate
  facilities and personnel, including obstetric
  anesthesia, nursing personnel, and a physician
  capable of monitoring labor and performing
  cesarean delivery, immediately available during
  active labor to perform an emergency cesarean
  delivery. The definition of immediately
  available personnel and facilities remains a
  local decision based on each institutions
  available resources and geographic location.
• ACOG Committee Opinion, 256, May 2001

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ASA Editorials

• Anesthesia staffing for obstetrics There are no
  specific answers to such questions, as each must
  be individualized for the local situation and
  resources.
• ASA, ACOG and AAP are recommendations and
  guidelines rather than standards

ASA October 2000 Newsletter. Marianna Pl
Crowely, MD, chair, Committee on Obstetrical
Anesthesia. Obstetric Anesthesia Recent
Guidelines for Our Availability to the Labor
Floor.
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JCAHO

• Hospitals providing obstetric or emergency
  operative services can provide anesthesia
  services within 30 minutes after anesthesia is
  deemed necessary
• In organizations providing labor services for
  patients seeking vaginal birth after previous
  cesarean delivery, appropriate facilities and
  personnel, including obstetric anesthesia and
  nursing personnel, are immediately available to
  perform cesarean delivery while conducting labor
  for women with a prior uterine scar
• References local definitions from ACOG/ASA
  statement

2001 JCAHO Standards for Sedation and Anesthesia
Care
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Lyndon Rochelle

• Retrospective cohort WA using ICD-9
• Linked with birth certificate
• 1987-1996 primips with prior c/s
• Type NOT specified
• Rates of rupture
• 0.16 with elective repeat
• 0.52 SOL
• 0.77 IOL no PG
• 2.45 IOL with PG

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Problems In General with Studies

• Are all live, non-anomalous fetuses?
• more aggressive with IUD, CM
• Ascertainment bias
• After TOL more likely to call defect a UR
• ICD-9 codes inaccurate (NH, MA x2)
• 50 not UR, include extensions, more likely with
  TOL
• 50 not symptomatic UR
• Temporal trends with declining PVP
• What do you compare complications to?
• How is the denominator determined
• Are all really TOL candidates
• How many prior classical c/s or unknown scars
  included
• How many had gt 2 cesarean deliveries?

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Criticism Lyndon-Rochelle

• Most of the above
• Combines 80 UR _at_ TOL with 11 UR _at_ ERCS
• Cant determine if postpartum complications due
  to TOL
• Parrish 1989 WA linked files
• IOL sens 71.7, PVP 80.4
• VBAC only 84.6 coded with combined data, lowest
  was 25 at one hospital

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The Problem

• 12 of pregnant women a prior c/s Sachs
• Elective Repeat Cesarean Section (ECRS)
• accounts for 38 of all cesarean sections
• rate is increasing
• C/S is the 3rd most common procedure in NH

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TOL vs ERCS Complications

• Uterine Rupture (UR)
• Perinatal Demise
• Neonatal impairment
• Hysterectomy
• Bladder injury
• Transfusion
• Infectious morbidity
• Complications of vaginal delivery

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Uterine Rupture (UR)

• Williams Obstetrics Separation of the old
  uterine incision throughout most of its length,
  with rupture of the fetal membranes so that the
  uterine cavity and the peritoneal cavity
  communicate. In these circumstances, all or part
  of the fetus is usually extruded...
• Complete disruption of all uterine layers AND
• intraperitoneal or vaginal hemorrhage
• Need for hysterectomy
• Bladder injury caused by scar disruption
• Extrusion any portion of fetal-placental unit
• c/s for non-reassuring FHT or suspected UR

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Uterine Dehiscence
Williams Obstetrics ... fetal membranes are not
ruptured and the fetus is not extruded into the
peritoneal cavity ...
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Potential Risk Factors UR

• Incision type and closure
• IOL
• Pitocin
• PGE
• Foley
• Augmentation
• Prior VBAC
• Inter-delivery interval
• Arrest disorders
• Prior C/S indication
• Maternal and Gestational Age

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Overall UR Rate

• Miller N17,000 1982-83 0.7
• McMahon N 3000, 0.3
• Mozurkewich N 47,000 0.4
• Zelop N 2774 0.7
• Farmer N 7625 0.8

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SOL without augmentation

• Zelop 0.4
• Ravasia 0.45
• Lyndon Rochelle 0.5

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Prostaglandins

• PGE Gel
• Zelop 3.9 rr 3.2 (0.9-10.9)
• Ravasia 2.9 (rr 6) p0.004
• Lyndon Rochelle 2.45
• Flamm 1.3 (rr2) NS
• PGE Pit Zelop 4.5
• Misoprostol
• Wing 2/17 ruptured
• Cervadil
• Minimal data separately
• Often included in PGE preparation

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Foley Balloon/No PG

• Foley Ravisia 0.76 NS
• 118/129 also received Pitocin
• Pitocin started after Foley expelled
• No PG IOL Lyndon Rochelle 0.7
• Unclear if this is different from SOL

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Pitocin

• Labor Induction
• Leung no increase risk
• Zelop rr 4.6 (1.5 - 14.1)
• Ravisia rr2, NS
• Labor Augmentation
• Zelop rr 2.3 (0.8-7.0)
• If used for arrest of dilation
• Pitocin in General
• Flamm rr 3

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Inter-pregnancy interval

• Esposito lt 6 mos RR 3.92 p0.02
• time from delivery to conception
• linear trend present but p 0.06
• Shipp lt 18 mos RR 3.0 (1.2 - 7.2)
• time from delivery to delivery
• is same time as Esposito

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Layers of uterine closure

• Bujold OR increased 5.2
• Canadian retrospective chart review
• Methodology is good
• Use a chromic equivalent
• Zelop no increase 1984-96
• Phone call few single layer closures
• Durnwald SMFM oral, adequate power
• No increased risk UR
• Increased windows

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Number of prior c/s

• Many case series of 2 c/s and VBAC
• Large studies say risk increased
• Leung rr 2.6
• 5/13 UR on presentation had 3-4 prior c/s
• 1 c/s 0.66
• 2 c/s 2.3
• 3 c/s 2.8
• Miller rr 3.1 (1.95-4.79)
• Caughey OR 4.8 (1.8-13.2)
• 1 c/s 0.8
• 2 c/s 3.7

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Indication for Prior C/S

• Leung no increase with c/s for CPD
• Several other large studies, similar

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Prior successful VBAC

• Is not completely protective
• Zelop controlled for IOL etc
• rr 0.2 with prior VD
• includes VD prior to c/s
• Had 2 ruptures after 2 successful VBAC
• Leung 16/93 had prior VBAC
• Increases successful TOL

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Gestational Age

• Zelop
• No increase rupture lt or gt 40 weeks
• Increase success if SOL lt 40 weeks
• Decrease if IOL lt 40 weeks
• No difference if wait for SOL at gt 40 weeks
• Await SOL even after 40 weeks maintains rupture
  rate and success rate.

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Maternal Age

• Shipp 2002 Increased risk with maternal age
• Controlled for birth weight, IP interval, IOL and
  AOL
• lt30 0.4
• 30 - 34 1.3
• 35 - 39 1.4
• gt39 2.4
• Other studies control for maternal age
• Independent confirmation is warranted

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Epidural

• Probably no effect on UR
• Studies somewhat inconsistent
• Risk factors epidural also risks for failed VBAC
  arrest disorders.

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Arrest Disorder

• Leung 31/70 had dysfunction labor, mostly
  arrest dilation
• Documented by IUC showing adequate uc gt 2 hours
• Appropriate c/s would have prevented rupture
• Hamilton Case control
• UR labored 5.5 hours longer after dx arrest
  dilation
• Best dx lack of dilation gt 2 hours _at_ gt 3 cm
• Prompt c/s prevent 31-42 UR
• study used 5 definitions

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MFMU Cesarean Registry TrialMB Landon

• Prospective 4 year cohort 1999-2002
• 19 Academic centers
• Singletons with prior CS
• Chart review by research nurses
• Compared TOL to ERCS
• ERCS No other indications and no labor

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MFMU Cesarean Registry TrialMB Landon

• 45,981 women with prior c/s
• 15,800 ERCS
• 17,931 TOL (39)
• VBAC Success 73

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MFMU Cesarean Registry TrialMB Landon
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MFMU Cesarean Registry TrialMB Landon

• Conclusion trial of labor remains an option as
  the absolute risk for these complications is
  small.

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Risks for Uterine Rupture

• Clearly Increased
• Pitocin
• Prostaglandin
• 2 or more prior cesarean sections
• lt 18 months since prior delivery
• Arrest disorder
• Possibly Increased
• AMA
• Single layer closure
• Mechanical methods of ripening

• No Increase
• Epidural
• Macrosomia
• Gestational Age
• Indication prior c/s

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Summary UR

• Uterine Rupture
• Rageth Ravasia LR Mozur
• No h/o CS 0.0075
• ECS 0.19
  0.16 0.16
• SOL 0.40 0.45
  0.52
• IOL Prost 2.9
  2.45
• IOL no Prost 0.73
  0.77

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Signs of UR

• Dystocia present in 40 of cases
• Repetitive variable or late decelerations
• Abnormal FHR pattern in 70-80
• Decreases time until neonatal injury
• Pain is a late and rare finding
• Bradycardia is a late finding
• Abruption decreases time

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32 Minutes
10 Minutes
Leung et al, Am J. OB/GYN 1993
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Fetus Risks ERCS

• Respiratory vs Vag Delivery Levine
• TTN 3.5 vs 1.1 plt0.001
• RDS 0.2 vs 0.1 NS
• PFC 0.37 vs 0.08 plt0.001
• Respiratory vs TOL Hook
• TTN 6 vs 3
• Any respiratory complication RR 2.3 (1.4, 3.8)

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Fetus failed VBAC vs ERCS

• Increase infectious morbidity
• Hook 2 vs 0 (3 cases vs 0) proven sepsis
• Hook 12 vs 2 suspected sepsis
• No increase in respiratory complications Levine
• Hook Surprising number of routine VD have extra
  procedures done. Need for control group.

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UR Risk of Fetal Death/Injury

• Make sure they were all alive at start
• Need standardized assessments of injury
• Yap 0/19 intrapartum MM
• Lueng 2/86 death, 4/86 asphyxia
• Farmer 1/61 death
• LR 5/91 death
• Bujold 1/23 death, 2/23 ? Asphyxia
• Overall 3.2 risk death, 5.5 injury
• Standard quote 10 or overall 0.05 or 1/2000
• MBL 0.17 TOL vs 0.07, excess 0.1

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Maternal Injury with UR

• Cesarean hysterectomy
• 10-20
• Urologic injury
• Farmer15/61
• Lyndon-Rochelle 7/91
• Transfusion
• overall higher rates with repeat c/s
• Need comparison of ERCS vs failed TOL
• Baskett 33
• Farmer 13/61
• Death 0-1

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Social/Economic Impact

• C/S is 3rd most common procedure in NH
• ERCS accounts for 38 of all C/S
• HCUP Data 3,785 for C/S vs SVD
• Increases cesarean section rate
• NH VT 372 extra C/S 2002
• gt 7 M/adverse neonatal outcome from UR
• No choice for many women
• Nearest hospital offering VBAC gt 1 hour away
• Prior successful VBAC forced to C/S
• Parking lot labors

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How VBAC Effects You

• 11 - 12.5 all pregnant women prior c/s
• Pre-2000 40 will attempt
• 0.4 x 0.12 0.05 or 5 of your patients will
  present for VBAC
• 80 will be low risk
• Service of 200
• 10 VBAC/year
• 2 Medium or High risk

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VT/NH VBAC Project

• Goal Increase VBAC availability and safety for
  patients and providers
• Collaborative Creation Regional
• Protocol
• Consent form
• Patient Education Tool
• October 4, 2002 Official Release
• Matches resources to risk

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VT/NH VBAC Project Process

• All Hospitals NH and VT
• OB, anesthesia, administrators, med mal and
  health insurers, nursing, public health
  departments
• 180 first meeting, 50 for 5 follow up
• April 22 Literature review
• Combined materials from all hospitals
• 5 Follow ups Open collaboration

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VT/NH VBAC Project

• Regional Materials
• Consent
• Education
• Protocol
• Available at NNEOB.org
• Decided to form a QI Network
• 22 of 35 hospitals thus far have endorsed
• No reply
• Not offering VBAC and thus not discussing
• Hadnt reviewed yet

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Protocol

• Rigorous definitions
• Admission
• OR personnel
• Anesthesia personnel
• Matches resources to risk
• Of UR
• Of fetal injury
• No times
• Defines availability by location and activity
• Advises against use of prostaglandins

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Protocol

• Low Risk SOL, 1 c/s, normal tracing
• Notify anesthesia, OR, Pedi of admission
• OB on campus active phase
• Comply with Guidelines for Prenatal Care
• Medium risk 2 c/s, augmentation, IOL, lt 18 mos
• Anesthesia on campus active phase
• OR on campus active phase or plan in place if OR
  busy

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Protocol

• High Risk Definition
• Abnormal FHR pattern, not resolving
• No change in 2 hours despite adequate labor
• Bleeding like an abruption
• High Risk Resources
• Everyone available
• No other acute patient care responsibilities
• Rapid movement from decision to incision

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Anesthesia Recommendations

• Protocol
• Antepartum consultation
• MD available trained in conscious sedation
• ER physician
• Additional Suggestions
• C/S under local protocol
• Nurse dedicated to helping anesthesia
• Intrapartum consult and set up table
• Good communication regarding units status
• Work on emergency c/s protocols

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Anesthesia Reimbursement

• Antepartum consultation
• Review history
• Explain plan for emergency delivery
• DHMC Level 2 EM (180)
• Intrapartum consultation
• DHMC does not bill
• Monitored Anesthesia Care
• Time and level

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Implementation at DHMC

• Approval by VIC
• Prenatal Care
• Patient Education Brochure
• Sign VBAC Consent
• Have read consent and understand how risks relate
  to them
• Read Patient Education Brochure
• Understand what our hospital offers
• That the consent will be reviewed in labor and
  that they can change their mind
• In Labor
• Consider TS
• Review VBAC decision, and the patients risk
  factors and their decision and document in MR
• Notify Anesthesia and Pediatrics
• If HR status, consider labor in OR and adequate
  back up
• Active Labor
• IV
• Continuous EFM

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Conclusions

• Low risk for UR same risk of emergency c/s as
  other laboring patients
• Appropriate for community hospitals
• Will rarely impact on OR or life of providers
• Emergency c/s protocols needed everywhere
• Drills
• Evaluation of each procedure
• OB QI Network to track protocol effectiveness
• Women should have a choice

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The VT/NH VBAC Project
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Healthy Baby Mom
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NNEPQIN

• Regional Network of Hospitals MOU
• Hospitals own their data
• Governed by Consensus
• Mission Improve Perinatal Health in NNE
• QI Projects
• VBAC
• Emergency Cesarean Deliveries
• Regional Education Sessions
• Potluck
• Free Speakers
• Bare bones yearly CME meetings
• Data Analysis