Shoulder Dystocia

© 2011 PeriGen – Proprietary and Confidential 1

SHOULDER DYSTOCIAPERIGEN WEBINAR

SEPTEMBER 13, 2011


Our Agenda Today

• The Clinician’s Conundrum

• Another Approach

• Case Presentations: “ What would you do?”

• Practical Considerations

• Prospective Use Results to-Date

• PeriCALM Tracings and Tracing Analysis


“Clinicians Conundrum”


Some ACOG Risk Factors Are Presentin Almost ALL Births

• Macrosomia (> 4000g)• Maternal Diabetes• Obesity• Multiparity• Post Dates• Previous Shoulder Dystocia• Previous Macrosomia• Induction of Labor• Epidural Anesthesia• Operative Vaginal Delivery

Clinician’s Dilemma:ACOG Shoulder Dystocia Risk Factors and Intervention Guidelines

ACOG Intervention Present in Very few

CONSIDER CESAREAN DELIVERY:• Est. Fetal Wt. (EFW) > 4500g with Diabetes • Est. Fetal Wt. (EFW) > 5000g without Diabetes • Possibly with Past History of Shoulder Dystocia


Nonspecific Risk Factors / Stringent Intervention CriteriaMothers with and without Shoulder Dystocia

Mothers without Shoulder Dystocia

Mothers with Shoulder Dystocia

Shoulder Dystocia and

pBPI

With ACOG Risk Factors 92.4% 96.8% >98%

Meet or ExceedACOG Intervention

Criteria 0.22% 1.75% 15%


Birthweight Cannot Separate Groups With/Without SD


Case Presentation #1

BACKGROUND:• 25 y/o G1 at 40 5/7 wks • For induction re: post-dates• EFW 3900g • GDM well controlled on diet • Height: 5”2”; 155 lbs now• Max fundal height 39 cm• Weight gain 45 lbs • Cervix 2cm / 75% / Station -1


Question #1

• Regarding the potential of Shoulder Dystocia in this case (G1, 40 5/7wks, EFW3900, 5’2”, 155lbs, GDM), I would:

Options:

1. Not discuss it at this point, because risks are low

2. Discuss it before starting this induction

3. Discuss it only if first stage labor progress were slow

4. Discuss it only if Vacuum extraction were needed


Another Approach


A Different Approach to the Problem . . .

Shoulder dystocia with injury – not shoulder dystocia at large

Multiple factors – not a single factor

Interaction of maternal and fetal size – not simply additive


Distribution of birth weight

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Persistent injury versus Vaginal delivery w ithout SD

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Vaginal delivery 2051 ShD w ith Persistent injury 221

Distribution of Birth Weight: Vaginal Deliveries w/o Shoulder

Dystocia vs. SD with pBPI

PeriCALM Shoulder ScreenRisk Score Distribution:

Vaginal Deliveries w/o Shoulder Dystocia vs. SD with pBPI


Practical Considerations


PeriCALM Shoulder Screen in Prenatal Care 4 Simple Steps During Office Visit

Step 1. Checklist at 36 weeks

Step 2. Data Entry for Women with Risk Factors


PeriCALM Shoulder Screen in Prenatal Care 4 Simple Steps During Office Visit

Step 4. Discuss & Document Informed Consent

Step 3. Obtain Risk Assessment

Risk Score 0.10 0.30 0.50 0.70 0.90

Average Risk of SD w/pBPI 1 / 24,847 1 / 1,753 1 / 511 1 / 227 1 / 124


PeriCALM Shoulder ScreenTraining Tutorial


Case Presentation 125 y/o G1, 40 5/7 wk, GDM, EFW 3900, 5’2”, 155Lbs, induction planned


Case Presentation 2

• 3 years later • 28 y/o G2P1 • SRM at 39 wks• EFW 4100, • Now 195 lbs, GDM controlled on diet• Previous SVD 4000g, No SD


Question #2

Regarding the potential of Shoulder Dystocia in this case (G2, 39wk, EFW4100g, GDM, 195lbs, H/O SVD 4000g), I would: Options:

1. Not discuss it at this point, because risks are low

2. Discuss it before starting this induction

3. Discuss it only if first stage labor progress were slow

4. Discuss it only if Vacuum extraction were needed


Case Presentation 228 y/o G2P1, SRM at 39 wks EFW 4100, now 195lbs, GDM controlled on diet, EFW 4100, previous SVD 4000g, No SD


Prospective Use Results


PeriCALM Shoulder ScreenProspective Use Results

1. Is the Program Feasible?

2. Did We Cause Harm? CS rates

3. Did We Help? Shoulder Dystocia rates Shoulder Dystocia with Injury Rates


Prospective UseSecond Large Outcome Study

Opportunity to track outcome on all births across a large hospital system

EMR – PeriBirth® – in the hospital and PeriCALM Shoulder Screen™ in some physicians’ offices


Characteristics of Study Population

• 20,725 Singletons at 36 weeks or greater – 8,767 With providers enrolled in formal risk assessment program– 11,958 with providers not enrolled

• Total CS rate 38.6%– Primary 21.1% Repeat 17.6%

• Shoulder Dystocia (216 cases, all pediatric records reviewed) – Per all births 1.0% – Per vaginal birth 1.7% – Complicated SD

(SD with Any of the following : BPI, Intubation, Bag and Mask ventilation, Fracture)


Trend Analysis for Enrolled Clinicians

Analysis Period

# Births >=36 weeks

% Tested

% CS

% Primary CS

% Repeat

Shoulder Dystocia

Rate Complicated

SD Rate

1 2753 6.4% 37.2% 21.2% 15.9% 1.74% 0.22%2 2343 13.9% 39.4% 22.7% 16.8% 1.66% 0.21%3 2464 15.0% 41.0% 21.0% 20.0% 0.97% 0.12%4 1207 16.7% 40.8% 20.8% 20.0% 0.75% 0.00%

(# SD/All Births)

(# Complicated SD/All Births )

P value <0.0001 0.0043 0.5721 < 0.0001 0.002 0.101

“Complicated SD” Any SD with BPI or Fracture or Intubation or Bag and Mask Ventilation


PeriCALM Shoulder ScreenProspective Use Results

1. Is the Program Feasible? Yes

2. Did We Cause Harm? NO Primary CS rates was stable

3. Did We Help? Yes, Shoulder Dystocia rates - Decreasing Complicated Shoulder Dystocia – looks very interesting, not yet

statistically significant Persistent BPI will required many many years


Shoulder Dystocia Risk Reduction ProgramIncludes CME Courses

Shoulder Dystocia EducationOnline & Webinars


Peer Reviewed Publications

Hamilton EF, Ciampi C, Dyachenko A , Lerner HM, Miner L, Sandmire HF. Is Shoulder Dystocia with Brachial Plexus Injury Preventable? Fetal and Maternal Medicine Review, 2008:19:(4) 293-310.

Foy DiGeronimo T, Hamilton E, Daly MV, Goley RB. Shoulder dystocia: neither predictable nor preventable? not anymore. MD Advis. 2011 Summer;4(3):18-24.

Lerner H, Durlacher K, Smith S, Hamilton E. Relationship between head-to-body delivery interval in shoulder dystocia and neonatal depression. Obstet Gynecol. 2011 Aug;118(2 Pt 1):318-22.

Comment on Iffy et al. "The risk of shoulder dystocia related permanent fetal injury in relation to birth weight". Sandmire HF, Hamilton E. Eur J Obstet Gynecol Reprod Biol. 2009 Feb;142(2):166; author reply 166-7. Epub 2009 Jan 3.

Dyachenko A, Ciampi A, Fahey J, Mighty H, Oppenheimer L, Hamilton EF Prediction of risk for shoulder dystocia with neonatal injury. Am J Obstet Gynecol. 2006 Dec;195(6):1544-9.


Questions

Contact: www.PeriGen.com

http://www.perigen.com/


Electronic Fetal Monitoring

• Real time at the point of care • Based on NICHD definitions• Unbiased, continuous analysis• Unaffected by operator inexperience, fatigue, distractions

Computerized Analysis of Electronic Fetal Monitoring

Peri CALM Patterns


Uterine Tachysystole

Computerized Analysis of Contraction Rate

PeriContractility Index

• Visual Alerts when excessive contraction rates occur and persist beyond acceptable limits


Labor Progression

• Shows how cervical dilation is progressing • Expected range is adjusted for conditions that change during labor • Consistent • Quantifiable • VBAC , identified 42% rupture cases hours before delivery • Relevant in assessing cesarean rates

Computerized Analysis of Labor Progression

PeriCALM Curve


Discussion

Contact: www.PeriGen.com

http://www.perigen.com/



PeriCALM Shoulder Screen in Prenatal Care Top Allegations Are Addressed

Risk Factors Were Not Recognized Patient Uninformed of Her Own Risk Patient Not Given Choice of Delivery MethodNo Documentation of Informed Consent Faulty Delivery Technique


Shoulder Dystocia Risk Reduction ProgramAdditional Benefits

• Potential Financial benefit– Liability insurance premium reduction

• Special recognition as forward thinking advocates for mothers


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SDscore Calculated at Delivery

Cesarean Rate and Delivery Volume vs SD Score at Delivery

Tested Not tested Linear (Tested) Linear (Not tested)

Tendency of Cesarean Rates With and Without Test


Delivery Volume Concentrated in Low Scores Range

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Risk Level at Delivery

Cesarean Rate and Delivery Volume vs Risk Level at Delivery

Tested Not tested Number of Mothers


• CS rate 34 - 37% 8000• SD rate 1.5% - 1.0% 15,500• SD with any injury 0.25%-0.125 37,500• SD with persistent BPI 0.015% -0.0075% 650,000


Shoulder Dystocia

• Personalized estimate of risk of shoulder dystocia with BPI• Based on multiple factors • Communicate graphical and actual numerical estimate • Identifies 4 to 5 times more that standard methods • Easy to use - no special equipment required

Computerized Assessment of Risk Of Shoulder dystocia with Brachial Plexus Injury

Peri CALM Shoulder Screen


Trend Analysis for Enrolled Clinicians

AnalysisYr# Births

>=36 weeks %

Tested %

CS %

Primary CS%

Repeat

Shoulder Dystocia

Rate Complicated

SD Rate 1 3592 0.06% 38.3% 21.0% 17.3% 1.06% 0.14%2 3324 0.21% 39.3% 21.8% 17.4% 0.66% 0.12%3 3325 0.27% 36.6% 19.4% 17.2% 0.63% 0.12%4 1717 0.17% 38.0% 20.8% 17.2% 0.87% 0.23%

(# SD/All Births)

(# Complicated SD/All Births )

P value 0.2729 0.2477 0.8667 0.221 0.5602

“Complicated SD” Any SD with BPI or Fracture or Intubation or Bag and Mask Ventilation

Documents

Shoulder Dystocia