# Presentation: 663886

## Vaginal Birth after Cesarean: Still a Viable Option? 

- Michele R. Lauria, MD, MS
- Associate Professor Ob/Gyn and Radiology
- Dartmouth Hitchcock Medical Center
- Medical Director NNEPQIN

## Objectives

- Discuss the evidence and controversy that continue to exist  around VBAC as a delivery option
- Describe NNEPQIN's tools for increasing the availability and patient and provider safety of VBAC in the northeast US.
- VBAC Guidelines,
- Consent for Birth After Cesarean Section, and 3) Birth
- Choices after a Cesarean Section.

## Outline

- History of VBAC
- National guidelines
- Literature Review
- NNNEPQIN Guidelines
- Practical Application

## 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...”
- Research Definition
- 	Complete disruption of all uterine layers AND 1
- 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 or suspected UR

## Uterine Dehiscence

- Williams Obstetrics: ... “fetal membranes are not ruptured and the fetus is not extruded into the peritoneal cavity” ...

## Slide 6

## Slide 7

## 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”
- 1999: ACOG Practice Bulletin:  “immediately available”
- 2000: Local Definition ACOG & ASA
- 2001: JCAHO adopts same language
- 2001:  Lydon Rochelle
- 2002:  VBAC services start closing
- 2002:  VT/NH VBAC project completed
- 2004:  ACOG publishes new guidelines
- 2005:  Landon MFMU Network Study

## 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 institution’s  available resources and geographic location.

## 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 institution’s  available resources and geographic location.
- ACOG Committee Opinion, #256, May 2001

## Areas lacking VBAC support 10/2005

## National Total CS, Primary CS, VBAC 

## Declining VBAC Rate

- Definition:  Vaginal delivery rate for all women with prior cesarean
- Proportion eligible
- Proportion attempting
- Proportion successful
- Declining rate of attempts
- Closed hospitals
- Patient/provider preference

## Declining Attempts

- Negative publicity lay and medical press
- Lyndon-Rochelle:  Higher rate UR with Prostaglandins than prior reports
- Large Med-mal awards, rising premiums, refusal to insure
- Ambiguous definitions/standards
- “Immediately Available”
- ACOG:  Locally defined in communications
- Elective primary cesarean movement
- Home Birth VBAC

## Social/Economic Impact

- C/S is 3rd most common procedure in NH
- ERCS accounts for 38% of all C/S
- HCCUP Data:  $3,785 for C/S vs SVD
- NH & VT 372 extra C/S 2002
- 1,408,020
- Litigation
- > $ 7 M/adverse neonatal outcome from UR
- No choice for many women
- Nearest hospital offering VBAC 1 hour away
- Prior successful VBAC forced to C/S

**Notes:**
HCCUP:  Heatlh Care Cost and Utilization PRoject

## ACOG Guidelines 2004

- No randomized trials TOL vs ERCS
- Most studies tertiary or university centers
- VBAC candidates are
- One prior LTCS
- No other uterine scars or prior UR
- Clinically adequate pelvis
- MD in active phase capable of monitoring and c/s
- Available anesthesia and personnel for emergency c/s

## ACOG > 1 Prior C/S

- UR risk 1-3.7%
- If control for confounders, 5 fold increase UR (~2.5%)
- Based on a single study
- If 2 prior c/s and prior vaginal delivery
- 1⁄4 as likely to have a UR
- These are candidates

## Contraindications for VBAC

- Prior classical, T or extensive transfundal uterine surgery
- Previous UR
- Inability to perform an emergency cesarean delivery
- 2 prior c/s and no prior vaginal deliveries

- Equipped to respond to emergencies with MD immediately available to provide emergency care
- After counseling, decision by patient and her physician
- Document in medical record

## RISK ASSESSTMENT

**ALL VBACS ARE NOT EQUAL**

## Risks for Uterine Rupture

- Clearly Increased:  _>_ 2 well done studies
- Pitocin
- Prostaglandins
- 2 or more prior cesarean sections
- < 18 months since prior delivery
- Dystocia
- Possibly Increased: 1 study
- AMA
- Single layer closure (1 says yes, the other no)
- Mechanical methods of ripening
- No Increase:  _>_ 2 studies evaluating
- But may increase the risk of dystocia
- Epidural
- Macrosomia
- Gestational Age
- Indication prior c/s

## Summary UR

- Uterine Rupture
- 			_**Rageth   Ravasia    LR   Mozur   Landon**_
- No h/o CS       0.0075%
- ECS                 0.19%                 0.16%   0.16%
- SOL                 0.40%    0.45%   0.52%                0.4%
- IOL Prost                         2.9%   2.45%		  1.4%
- IOL Pit                            0.73%   0.77%		  1.1%

**Notes:**
So what are the true risks of uterine rupture?

Read slide

## Signs of UR

- Unrecognized dystocia 40% of cases
- 2 case control studies:  US and Canada
- Average length arrest disorder:  5 hours
- 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

## EFM and Uterine Rupture“Nonreassuring fetal monitoring tracing is the 1st sign” 

- Variable decelerations progressing to bradycardia in 50 minute timeframe
- The most typical pattern in uterine rupture

**Ann Darlington, CNM**

## EFM and Uterine Rupture

- Regular, then sudden cessation of contractions

**Ann Darlington, CNM**

## EFM and Uterine Rupture

- Recurrent late decelerations and decreased variability over 2 hours’ time frame
- Pitocin induction
- Placenta delivered with infant
-         (Images from: *JOGNN*, 33, 105-115; 2004)

**Ann Darlington, CNM**

## 10 Minutes

- Leung et al, Am J. OB/GYN 1993

- 32 Minutes

## Fetus: Risks ERCS

- Respiratory: vs Vag Delivery* Levine*
- TTN 3.5% vs 1.1% p<0.001
- RDS 0.2 vs 0.1% NS
- PFC 0.37% vs 0.08% p<0.001
- Respiratory vs TOL *Hook*
- TTN 6% vs 3%
- Any respiratory complication RR 2.3 (1.4, 3.8)

## Fetus: failed VBAC vs ERCS

- Increase infectious morbidity
- Hook 2% vs 0% (3 cases vs 0) proven  sepsis
- Hook 12% vs 2% suspected sepsis
- Hook:  surprising number of routine VD have extra procedures done.  Need for control group.

## UR Risk of Fetal Death/Injury

- Make sure they were all alive at start
- Need standardized assessments of injury
- Yap: 0/19 intrapartum M&M
- 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%

## The Plague of VBAC 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 > 2 cesarean deliveries?

**Notes:**
665.0 and 665.1 are the most common
674.1 also
Over codes by 50% for rupture (MA, NH, WA)
Intra-operative extension
Incidental dehiscence
Of true rupture, < 50% were severe
NH, MA, 
Allows extension at time of c/s
Potentials for bias
After TOL thinned LUS, extension more likely
Diagnosis bias
Says nothing about symptomatic rupture
Have seen temporal trends... PPV has been declining.
Registry codes linked with ICD-9
NH experience:  
CDC 200 states use of hospital discharge data in inaccurate

## Slide 33

## Methodology

- Prospective observation study  (level B)
- 4 years:  1999-2002
- All women with a prior cesarean delivery
- 17,898 TOL vs 15,801 ERCS
- TOL:  presenting in labor at _>_ 4 cm or receiving pit
- If presented in early labor and having c/s were excluded because couldn’t tell if they were planned ERCS
- ERCS:  no medical indication: ie classical or maternal health
- 19 academic medical centers
- Research nurses collecting data

***Landon et al NEJ 2004***

## Patient Population

- 378,168 birth during the study period
- 45,988 women singleton gestation with prior c/s
- 38.9% N= 17,898 TOL
- 34.4% N= 15,801 ERCS
- 23.7% N= 12,289 excluded
- 9013 had indicated repeat c/s
- 7.1% N= 3276 women presented in early labor without a plan documented
- Rate of TOL
- Range 18.7-63.2%
- Overall 48.3% 1999 declining to 30.7% 2002
- Success Rate:  73.4%

***Landon et al NEJ 2004***

## Rates of UR by Labor Status

***Landon et al NEJ 2004***

## Maternal Complications

- UR includes 2/102 with low vertical incision and 2/105 with classical/T/J incisions

***Landon et al NEJ 2004***

## Maternal Outcomes by TOL Success

***Landon et al NEJ 2004***

## Perinatal Outcomes Term Infants

***Landon et al NEJ 2004***

**Notes:**
More TOL patients were > 41 weeks (12.4 vs 4.2%) and were < 37 weeks:  14.1% vs 5.0%
Of the 12 HIE:  7 were in setting of uterine rupture, 4 were in setting of c/s for NRFA, 1 was a vaginal delivery without UR.  So risk of HIE due to UR is 7/15,338.  Two of these infants died.
With the UR:  no intrapartum deaths.
Of the NND:  

## Perinatal Outcome with UR

***Landon et al NEJ 2004***

**Notes:**
The 2 NND also had HIE, so 7/114 with UR had adverse outcome.

## Excess Morbidity/Mortality TOL

- Exclude antepartum SB as increased anomalous fetuses in TOL
- 0.16% TOL vs  0.05
- Excess of 0.1%; or 1/1000
- Not all excess related to uterine rupture
- Increased still birth
- Anomalies
- More postdate pregnancies
- 7/12 HIE associated with UR; 2 died
- Overall, 7/15,338 (0.045%) or 1/2000 risk of adverse neonatal event due to UR.
- Risk NND from TOL vs ERCS: Can’t determine NND since anomalies and PTD included
- Risk HIE from TOL vs ERCS:  0.08% or allmost 1/1000

***Landon et al NEJ 2004***

## MFMU: Multiple vs Single C/S Risk of UR

- Multiple c/s UR rate 0.9% (9/975)
- Single c/s UR rage 0.7% (115/16915
- P=0.37
- Multivariate analysis controlling for IOL, pitocin, prior vaginal delivery confirmed the finding
- Increased maternal morbidity with multiple c/s vs single
- Hysterectomy 0.6% vs 0.2% p=0.23
- Transfusion 3.2% vs 1.6% p < 0.001
- Increased composite maternal morbidity with TOLAC vs ERCS in multiple c/s group
- Increased composite maternal morbidity
- OR 1.41 (95% CI 1.02-1.93)

- Landon 2006:  Obstet Gyencol; 108:12

## Maternal Complications Associated With Multiple Cesarean Deliveries

- Retrospective cohort study N=277 > 2 cs with N=491 2 cs
- More than 2 cs associated with
- Excessive blood loss 7.9% versus 3.3%; P < .005
- Difficult delivery of the neonate  5.1% versus 0.2%; P < .001
- Dense adhesions 46.1% versus 25.6%; P < .001
- Proportion of women having any major complication  P < 0.004
- 2 cs 4.3%
- 3 cs 7.5%
- 4 or more cs 12.5%
- accreta risk with >= 4 4.7% vs 0.6% p < 0.05

- Nisenblat obstet Gynecol 2006 108:21-6

## When Does VBAC Make Sense?

- Points of view
- Patient:  Out of pocket, time from work and family, loss of function, long term care
- Provider:  Time out of office, med mal, insurance
- Payer:  Actually paid to hospital for mom and baby
- Society as a whole
- Use Bottom Up or Micro-costing for Hospital Costs
- Vaginal Delivery $4950
- ERCS $7,244
- Failed TOL  $8,414
- Any major complication mom or baby: extra $6000

## Results

- TOL is cost-effective if
- Probability success > 0.74
- Costs of failed TOL exceed ERCS
- Include costs of folks on stand by
- TOLAC is not significantly cost saving!

- Macario  Clinical Obstetrics and Gynecology 47:378-85; 2004

- TOL is cost effective if
- Success > 50%
- 10-20% chance of wanting another child
- Delayed risks of cesarean section are greater than it’s immediate benefit
- Risks of previa, abruption etc

## Predicting a Successful TOLAC

## Predicting vaginal brith after cesarean delivery:  A review of prognostic factors and screening tools Hashima AJOG 190:547-55

- Medline/HealthSTART search
- 13 of 100 studies fair to good quality on 12 factors
- 2/6 screening tools had been validated
- Conclusions:
- Little high quality data
- Tools need to be user-friendly
- Need research to determine clinical setting best in
- Should be national research priority

## Predicting vaginal birth after cesarean delivery:  A review of prognostic factors and screening tools Hashima AJOG 190:547-55

- Significant Factors Increasing Success
- # prior VD
- If prior VD after c/s
- GA < 37 weeks
- Birth weight < 4000 grams
- Dilation
- Effacement
- Flamm 1997 best article
- Developed on n=2502
- Tested on n=2501

## Can a scoring system predict VBAC success?Flamm, Obstet Gynecol 1997;90:907-10

**TOTAL = 10**

## Performance of scoring system Flamm, Obstet Gynecol 1997;90:907-10

**Note: 50% success even with score 0-2**

## Flamm 1997

- 18% predicted low likelihood
- Score 0-3
- False-negative ratio 10%
- 253/2405 incorrectly advised to have C/S when could have had VD
- False-positive ratio 2.6%
- 63/2405 fail TOL after being told to try

## Induction of labor after one prior cesarean:  predictors of vaginal deliveryGrinstead Obstet Gynecol 103:534-8

- Retrospective review 429 charts
- All IOL
- Predictors poor success
- CD for dystocia
- GA > 40 weeks
- Unfavorable cervix
- Any type diabetes

## Chance of VBAC in women undergoing IOL for TOLAC

- Grinstead Obstet & Gynecol 103:534-8, 2004

- Overall 77.9% success rate
- 	Retrospective chart review of N=429 at Northewestern
- 	OVD rate of 14.1%

**Notes:**
Study Title:  IOL after 1 prior c/s: predictors of vaginal delivery
Retrospective chart review 1996-2001
Inclusion Cirteria
1 prior CS
Singleton
Vertex
Scheduled IOL
Intact membranes
UC < 10 min
GA > 34 wks
N=429
77.9% success TOL
Of these 14.1% OVD
Northwestern University
Cervical ripening N=96 (22%): 
Extraamniotic saline 86%
Osmotic Dilators 12.5%
68% elective IOL
4 cases symptomatic UR
2 diagnosed after OVD
2 at CS for NRFHR
1 associated with PG for ripening
Only time they used it
1 required hysterectomy
2 maternal ICU admissions
1 NICU admission
5 Asymptomatic Dehiscence
4 noted at CS for arrest of dilation

## Macario  Clinical Obstetrics and Gynecology 47:378-85; 2004

## Results:  Predictors of Failed TOL

- Women without prior VD
- MA _>_ 35
- Insulin requiring DM
- Prior c/s for dystocia
- IOL
- Cervical ripening
- Birth weight > 4000g
- Actual birth wt > prior birth wt
- Women with prior VD
- MA _>_ 35
- Birth weight > 4000g

- Bujold:  Am J Ob/Gyn 190:113-8, 2004

- Retrospective chart review 1995-6 16 hospitals
- N=9960
- Singleton with 1 prior CD
- Risk groups based on number and timing of vaginal deliveries
- If no prior VD:
- decrease success with birth weight
- Increase UR with birth weight > 4000 grams
- If prior VD:  no effect of birth weight

## MFMU:  Factors affecting the success of TOLAC

- Increased likelihood of successful VBAC
- Prior vaginal delivery
- C/s  for malpresentation or non-dystocia
- Birth weight < 4000 grams
- BMI< 30
- SOL
- Cervical dilation> 4 cm on admission
- Obese women, without prior vd, requiring induction
- Only those with prior c/s for malpresentation have success rate > 50%

- Landon Am J Obstet Gynecol 2005: 193;1016

## MFMU:  Development of a Nomogram for predicting successful TOLAC

- ROC:  Area under the curve 75.4%
- With validation data set, ROC area unchanged

## MFMU:  Development of a Nomogram for predicting successful TOLACGrobman: Obstet Gynecol 2007: 109:806

## TwinsLandon:  MFMU

- Sub-analysis of prior study
- N=412 twins, 45.1% had a TOL
- VBAC success rate 64.5%
- Of the 66 women with failed TOL, 30 had vaginal delivery of A with c/s of B.
- 9 Vtx/Breech
- 21 Breech/Breech
- For women with TOL
- No increase adverse maternal outcome vs ERCS
- With GA adjustment, neonatal outcomes similar
- Rate of UR was 1.1%

- Am J Obstet Gynecol 193:135-140

**Notes:**
TOL twins delivered 3 weeks earlier, much more likely to be < 27 weeks (19/20 < 27 weekers were TOL) and more liekly to have lethal anomlaies

## Sonographic Thickness of the LUS

- Rozenberg Lancet 1996
- N=642 prior c/s prospectively followed
- LUS <=3.5 mm 20x increased risk UR
- Sensitivity 88%, specificity 73%, PPV 12%, NPV 99%
- 5 follow up validation studies, all with single sonographer
- Jastrow Ultrasound Obstet Gyecol 2006
- Intraobserver variability ~ 1mm
- Interobserver variability poor with TAUS, high with TVUS
- However TAUS did not compare with TVUS, so unclear what cut off should be used with TVUS

## VT/NH VBAC Procject

- Goal:  Increase VBAC availability and safety for patients and providers
- Collaborative Creation Regional
- Protocol
- Consent form
- Patient Education Tool
- October 4, 2002 Official Release
- September 2005 Update
- Matches resources to risk

## VT/NH VBAC Project:  Process

- All Hospitals NH and VT
- OB, anesthesia, administrators, med mal and health insurers, nursing, public health departments, home birth midwives
- 180 first meeting, 50 for 5 follow up
- April 22 2002:  Literature review
- Combined materials from all hospitals
- 5 Follow ups: Open collaboration
- Tools
- Guideline
- Patient Education Document
- Consent Form

## Guideline

- 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

## Guideline

- Low Risk: SOL, 1 c/s, normal tracing
- Notify anesthesia, OR, Pedi of admission
- OB on campus active phase
- Medium risk: 2 c/s, augmentation, IOL, < 18 mos
- Anesthesia on campus active phase
- OR on campus active phase or plan in place if OR busy

## Guideline

- 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

## What is NNEPQIN Doing

- PCOS Study
- Registry of resource utilization, risk escalation and outcome in women with prior c/s
- Prospectively filled out data sheet
- Updated Guidelines 2005
- WWW.NNEPQIN.Org

## PCOS Study Design

- Observational, Cross-sectional study from 2004-2007
- Questionnaire completed at time of delivery
- Community and Tertiary Care Centers
- Voluntary participation
- Designed as a Quality Assurance/Quality Improvement Project of NNEPQIN
- IRB approval
- Subjects:  All women with a prior cesarean section presenting for delivery
- No Exclusion Criteria

## “Answer the following questions for all women with a prior cesarean section:”

| OR Personnel |  None required or routine staff used
 Staff stayed over*
 Came in from Main OR*
 Staff called emergently from home* |
| --- | --- |
| Anesthesia Personnel |  None required or routine staff used
 Staff stayed over*
 Came in from Main OR*
 Staff called emergently from home* |
| OR Cases |  None Affected
 Start Delayed*
 Rescheduled* |
| Care Plan of Other OB Patients Changed |  No
 Yes* |

*** “additional” resources used**

## Statistical Analysis

- Power calculation: setting ****=0.05 and ****=0.2, requires n=204 to detect an absolute difference of 20% assuming one third attempt TOLAC
- Statistical tests: Fisher’s exact, Pearson’s chi square, clustered multivariable logistic regression
- Odds Ratios with 95% confidence intervals were calculated to describe the effect of anticipated mode of delivery on resource use

## Outcome Variable

- Composite Resource Use
- OR Personnel
- Anesthesia Personnel
- OR Cases
- Work-Flow of the OB Unit

## Proportion of Submissions 

- 279 Deliveries

## Patient Characteristics

|  | Community Hospitals
N=117 | Tertiary Centers
N=162 |
| --- | --- | --- |
| TOLAC candidate  | 69% | 71% |
| Attempting TOLAC | 19% | 35% |
| Induction of labor if TOLAC | 12% | 12% |
| Escalation of risk if TOLAC | 39% | 58% |
| Priority of delivery  stat or urgent  | 3% | 7% |
| Major maternal complications | 2% | 4% |
| Delivery prior to 37 weeks | 4% | 11% |

## Clustered Multivariable Analysis 

|   | Unadjusted
OR
(95% CI) | P value | Adjusted
OR
(95% CI) | P value |
| --- | --- | --- | --- | --- |
| TOLAC | 1.7
(0.8-3.6) | NS | 1.23
(0.4-3.5) | NS |
| Delivering in Community Hospital  | 1.5
(0.6-3.8) | NS | 4.0
(1.2-13.3) | 0.02 |
| Stat or Urgent Priority of Delivery | 9.0
(2.2-37.3) | 0.002 | 8.5
(1.6-46.1) | 0.01 |
| Maternal Complications | 12.4
(2.3-65.9) | 0.002 | 7.1
(1.0-52.4) | 0.05 |
| Preterm Birth | 4.6
(1.5-13.7) | 0.004 | 4.4
(1.2-15.8) | 0.01 |
| Induction | 2.6
(0.5-13.8) | NS | 2.0
(0.3-15.3) | NS |
| Risk Escalation in labor | 2.1
(0.9-4.6) | 0.08 | 0.85
(0.3-3.2) | NS |
| >10 prior CS deliveries/100 births
 | 0.6
(0.2-2.3) | NS | 0.4
(0.1-1.4) | NS |

## Conclusions

- TOLAC, compared to ERCS, does not require additional hospital resources
- Factors associated with additional hospital resource use include: 1) need for stat or urgent cesarean section, 2)  occurrence of maternal complications, 3) preterm birth, or 4) community hospital setting

## Implications

- Adoption of policies against TOLAC is unlikely to reduce the resources hospitals expend in caring for women with prior cesarean sections