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Rethinking
the Labor Curve
Emily Hamilton MD CM
SVP Clinical Research PeriGen
1
Featuring Emily Hamilton, MDCM
Senior Vice President of Clinical Research
An experienced obstetrician, Dr.
Hamilton is currently an Adjunct
Professor of Obstetrics and Gynecology
at McGill University, as well as leading
PeriGen’s clinical research team.
Dr. Hamilton is the inventor of the
PeriCALM advanced fetal monitoring
system, holding 30 US and international
patents for her research work. She is an
internationally-known clinical thought
leader on the use of technology to
improve obstetric outcomes. She
presents her research regularly at
obstetric conferences and in peer-
reviewed journals.
3
Friedman Labor Curves
An Obstetrical Landmark
4
An Obstetrical Landmark
Original Friedman Graphs 1965, 1978
Friedman EA, Sachtleben MR. Station of the
fetal presenting part. II. Effect on the course of
labor. Am J Obstet Gynecol. 1965 Oct 15;93(4):
530-6
Friedman E: Labor: Clinical Evaluation and
Management, 2nd ed. New York, Appleton-
Century-Crofts, 1978) page 41
5
Angular Sigmoid Shape
Regions constant dilation rates
Narrow range of variation
Phases defined
Disorders defined
Arrest disorder
Protraction disorders
6
Modern Labor Curves
7
Zhang et al 2002
8
2002 1959-66 2004-8
9
Dilation
Time
Both Dilation and Station are Different
Zhang 2002 Friedman 1965
10
Wide Variation
Dilation
Median
hrs
Slowest 5%
hrs
2 to 3 3.2 15.0
3 to 4 2.7 10.1
4 to 5 1.7 6.6
5 to 6 0.8 3.1
6 to 7 0.6 2.2
7 to 8 0.5 1.5
8 to 9 0.4 1.3
9 to 10 0.4 1.4
11
Wide Variation Between 5th & 95th Percentiles
12
First Stage Arrest Definition
!  >= 6 cm, membrane rupture
!  No dilation for 4 hrs MVU high (>200)
!  No dilation for 6 hrs MVU low
13
No Sharp Angles and Wide Variation
?
Gradual Exponential
?
Angular and Sigmoid
14
Time Based Curves
When are they useful and when are they not useful?
15
Highly Reliable Time Based Curves
!  Direct and Fixed Relationship to time
Distance travelled by
a dropped ball
Gravity
16
!  Well-defined relationship to time
!  Narrow range of variation
Fetal growth curves
Useful Time-Based Curves
17
Minimally Useful Time-Based Curves
!  Indirect
relationship to
time (other things
cause the effect)
!  Wide range of
variation
Global Fertility Rates 18
Mathematical Models
What are they and why are they useful?
19
Mathematical Models are Equations
Describe Natural Behavior
Distance = ½ a * time 2
a = Uniform Acceleration Constant
20
Physiology: Many factors, often in constant flux
Multifactorial adaptive ± range
1.  natural biological variation
2.  measurement inaccuracy
3.  unmeasured factors
21
!  Dilation has an indirect relationship to time
!  Dilation is a direct response to contractions
!  Other factors can modify the response
Parity, effacement, epidural, rotation…
!  All change over time
Determinants of Dilation
22
Model Dilation as a Function of Contractions
Dilt = χ + γContractions+ αdil t-1 + βeffacement t-1 - δstation t-1 + øepidural ± range
+0 cm 10 cm
23
Normal Nulliparous Labor
GA 40.1
PVB 0
Delivery	
  Type NVD
BWT	
   3635
Apgar	
  1	
  min 5
Apgar	
  5	
  min 9
UA	
  pH 7.16
UA	
  Base	
  Excess -­‐7.2
Second	
  Stage	
  
(hours) 0
Second	
  Stage	
  
(minutes) 19
EBL 250
CPR
Intubation	
  in	
  
Delivery	
  Room
Indication
24
Normal Nulliparous Labor
25
Normal Nulliparous Labor
26
Nulliparous
CS Arrest of dilation, CPR, Intubation, EBL 1000
GA 41.3
PVB 0
Delivery	
  Type CS
BWT	
   3458
Apgar	
  1	
  min 3
Apgar	
  5	
  min 8
UA	
  pH 7.24
UA	
  Base	
  Excess -­‐0.7
Second	
  Stage	
  
(hours)
Second	
  Stage	
  
(minutes)
EBL 1000
CPR yes
Intubation	
  in	
  
Delivery	
  Room yes
Indication
Arrest	
  of	
  
Dil	
  
27
Nulliparous
CS Arrest of dilation, CPR, Intubation, EBL 1000
28
Performance
Relationship to Complications
Measuring Discrimination
Between Normal and Abnormal
% in
abnormals
% in normals
Area under the curve
1= perfect test
0.5 poor test like a coin
toss
30
Figure 1 PSA biomarkers for the
diagnosis of prostate cancer
Ploussard, G. & de la Taille, A. (2010) Urine biomarkers in prostate cancer
Nat. Rev. Urol. doi:10.1038/nrurol.2009.261
Urine PCA 3
AUC 0.787
Total PSA
AUC 0.564
%inCancerpts
% in normals
 	
  
Intervention
Outcomes	
  
Clinical Outcomes	
  
First Stage CD for
Labor Progress
Disorder	
  
CD for
Fetal Heart
Rate
Concern 	
  
Obstetrical
Hemorrhag
e	
  
Neonatal
Depression 	
  
32
 	
  
Intervention
Outcomes	
  
Clinical Outcomes	
  
First Stage CD for
Labor Progress
Disorder	
  
CD for
Fetal Heart
Rate
Concern 	
  
Obstetrical
Hemorrhag
e	
  
Neonatal
Depression 	
  
Duration of arrest
at dilation ≥6 cm 	
  
Dilation percentile 	
  
Station percentile 	
  
33
 	
  
Intervention
Outcomes	
  
Clinical Outcomes	
  
First Stage CD for
Labor Progress
Disorder	
  
CD for
Fetal Heart
Rate
Concern 	
  
Obstetrical
Hemorrhag
e	
  
Neonatal
Depression 	
  
Duration of arrest
at dilation ≥6 cm 	
  
0.65* 	
   0.55* 	
   0.52	
   0.52 	
  
Dilation percentile 	
  
Station percentile 	
  
34*P<0.01
 	
  
Intervention
Outcomes	
  
Clinical Outcomes	
  
First Stage CD for
Labor Progress
Disorder	
  
CD for
Fetal Heart
Rate
Concern 	
  
Obstetrical
Hemorrhag
e	
  
Neonatal
Depression 	
  
Duration of arrest
at dilation ≥6 cm 	
  
0.65* 	
   0.55* 	
   0.52	
   0.52 	
  
Dilation percentile 	
   0.93* 	
   0.81* 	
   0.60*	
   0.61* 	
  
Station percentile 	
  
35*P<0.01 Bold P<0.01 for comparison to duration of arrest
 	
  
Intervention
Outcomes	
  
Clinical Outcomes	
  
First Stage CD for
Labor Progress
Disorder	
  
CD for
Fetal Heart
Rate
Concern 	
  
Obstetrical
Hemorrhag
e	
  
Neonatal
Depression 	
  
Duration of arrest
at dilation ≥6 cm 	
  
0.65* 	
   0.55* 	
   0.52	
   0.52 	
  
Dilation percentile 	
   0.93* 	
   0.81* 	
   0.60*	
   0.61* 	
  
Station percentile 	
   0.82* 	
   0.78* 	
   0.61* 	
   0.58* 	
  
*P<0.01 Bold P<0.01 for comparison to duration of arrest36
ROC Nullipara with First Stage CS for Labor Disorder
37
	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  Sensi'vity	
  	
  	
  False	
  posi've	
  	
  Likelihood	
  Ra'o	
  
>	
  4	
  hrs. 	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  12.2	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  0.6	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  20.4	
  	
  
ROC Nullipara with First Stage CS for Labor Disorder
38
	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  Sensi'vity	
  	
  	
  False	
  posi've	
  	
  Likelihood	
  Ra'o	
  
<10th	
  percen2le	
  	
  	
  	
  	
  	
  69.3	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  4.9	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  14.2	
  
<	
  5th	
  percen'le	
  	
  	
  	
  	
  	
  	
  43.6	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  1.7	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  26.3	
  
Labor Progress Assessment
Time Curves
Arrest Criteria
• Static “One size fits all”
• Applicable in late labor only
• Pass/fail criteria for labor disorders
• Weak association with labor related
interventions
Adaptive Models
• Adjusts for multiple factors, adaptive
•  Applicable from 3 cm onward
•  Finely graded assessment
•  Strong association with labor related
interventions
39
Acknowledgments
Antonio Ciampi PhD Mathematics
Gabrielle Simoneau MSc Mathematics
Philip Warrick PhD Engineering
Bruno Bendavid BSc Comp Sci
Ebi Kimanani PhD Mathematics
Samuel Smith MD
Kathleen Collins RN
Thomas Garite MD
40
41
42
Thank you
43

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Rethinking the Labor Curve Presentation

  • 1. Rethinking the Labor Curve Emily Hamilton MD CM SVP Clinical Research PeriGen 1
  • 2. Featuring Emily Hamilton, MDCM Senior Vice President of Clinical Research An experienced obstetrician, Dr. Hamilton is currently an Adjunct Professor of Obstetrics and Gynecology at McGill University, as well as leading PeriGen’s clinical research team. Dr. Hamilton is the inventor of the PeriCALM advanced fetal monitoring system, holding 30 US and international patents for her research work. She is an internationally-known clinical thought leader on the use of technology to improve obstetric outcomes. She presents her research regularly at obstetric conferences and in peer- reviewed journals.
  • 3. 3
  • 4. Friedman Labor Curves An Obstetrical Landmark 4
  • 5. An Obstetrical Landmark Original Friedman Graphs 1965, 1978 Friedman EA, Sachtleben MR. Station of the fetal presenting part. II. Effect on the course of labor. Am J Obstet Gynecol. 1965 Oct 15;93(4): 530-6 Friedman E: Labor: Clinical Evaluation and Management, 2nd ed. New York, Appleton- Century-Crofts, 1978) page 41 5
  • 6. Angular Sigmoid Shape Regions constant dilation rates Narrow range of variation Phases defined Disorders defined Arrest disorder Protraction disorders 6
  • 8. Zhang et al 2002 8
  • 10. Both Dilation and Station are Different Zhang 2002 Friedman 1965 10
  • 11. Wide Variation Dilation Median hrs Slowest 5% hrs 2 to 3 3.2 15.0 3 to 4 2.7 10.1 4 to 5 1.7 6.6 5 to 6 0.8 3.1 6 to 7 0.6 2.2 7 to 8 0.5 1.5 8 to 9 0.4 1.3 9 to 10 0.4 1.4 11
  • 12. Wide Variation Between 5th & 95th Percentiles 12
  • 13. First Stage Arrest Definition !  >= 6 cm, membrane rupture !  No dilation for 4 hrs MVU high (>200) !  No dilation for 6 hrs MVU low 13
  • 14. No Sharp Angles and Wide Variation ? Gradual Exponential ? Angular and Sigmoid 14
  • 15. Time Based Curves When are they useful and when are they not useful? 15
  • 16. Highly Reliable Time Based Curves !  Direct and Fixed Relationship to time Distance travelled by a dropped ball Gravity 16
  • 17. !  Well-defined relationship to time !  Narrow range of variation Fetal growth curves Useful Time-Based Curves 17
  • 18. Minimally Useful Time-Based Curves !  Indirect relationship to time (other things cause the effect) !  Wide range of variation Global Fertility Rates 18
  • 19. Mathematical Models What are they and why are they useful? 19
  • 20. Mathematical Models are Equations Describe Natural Behavior Distance = ½ a * time 2 a = Uniform Acceleration Constant 20
  • 21. Physiology: Many factors, often in constant flux Multifactorial adaptive ± range 1.  natural biological variation 2.  measurement inaccuracy 3.  unmeasured factors 21
  • 22. !  Dilation has an indirect relationship to time !  Dilation is a direct response to contractions !  Other factors can modify the response Parity, effacement, epidural, rotation… !  All change over time Determinants of Dilation 22
  • 23. Model Dilation as a Function of Contractions Dilt = χ + γContractions+ αdil t-1 + βeffacement t-1 - δstation t-1 + øepidural ± range +0 cm 10 cm 23
  • 24. Normal Nulliparous Labor GA 40.1 PVB 0 Delivery  Type NVD BWT   3635 Apgar  1  min 5 Apgar  5  min 9 UA  pH 7.16 UA  Base  Excess -­‐7.2 Second  Stage   (hours) 0 Second  Stage   (minutes) 19 EBL 250 CPR Intubation  in   Delivery  Room Indication 24
  • 27. Nulliparous CS Arrest of dilation, CPR, Intubation, EBL 1000 GA 41.3 PVB 0 Delivery  Type CS BWT   3458 Apgar  1  min 3 Apgar  5  min 8 UA  pH 7.24 UA  Base  Excess -­‐0.7 Second  Stage   (hours) Second  Stage   (minutes) EBL 1000 CPR yes Intubation  in   Delivery  Room yes Indication Arrest  of   Dil   27
  • 28. Nulliparous CS Arrest of dilation, CPR, Intubation, EBL 1000 28
  • 30. Measuring Discrimination Between Normal and Abnormal % in abnormals % in normals Area under the curve 1= perfect test 0.5 poor test like a coin toss 30
  • 31. Figure 1 PSA biomarkers for the diagnosis of prostate cancer Ploussard, G. & de la Taille, A. (2010) Urine biomarkers in prostate cancer Nat. Rev. Urol. doi:10.1038/nrurol.2009.261 Urine PCA 3 AUC 0.787 Total PSA AUC 0.564 %inCancerpts % in normals
  • 32.     Intervention Outcomes   Clinical Outcomes   First Stage CD for Labor Progress Disorder   CD for Fetal Heart Rate Concern   Obstetrical Hemorrhag e   Neonatal Depression   32
  • 33.     Intervention Outcomes   Clinical Outcomes   First Stage CD for Labor Progress Disorder   CD for Fetal Heart Rate Concern   Obstetrical Hemorrhag e   Neonatal Depression   Duration of arrest at dilation ≥6 cm   Dilation percentile   Station percentile   33
  • 34.     Intervention Outcomes   Clinical Outcomes   First Stage CD for Labor Progress Disorder   CD for Fetal Heart Rate Concern   Obstetrical Hemorrhag e   Neonatal Depression   Duration of arrest at dilation ≥6 cm   0.65*   0.55*   0.52   0.52   Dilation percentile   Station percentile   34*P<0.01
  • 35.     Intervention Outcomes   Clinical Outcomes   First Stage CD for Labor Progress Disorder   CD for Fetal Heart Rate Concern   Obstetrical Hemorrhag e   Neonatal Depression   Duration of arrest at dilation ≥6 cm   0.65*   0.55*   0.52   0.52   Dilation percentile   0.93*   0.81*   0.60*   0.61*   Station percentile   35*P<0.01 Bold P<0.01 for comparison to duration of arrest
  • 36.     Intervention Outcomes   Clinical Outcomes   First Stage CD for Labor Progress Disorder   CD for Fetal Heart Rate Concern   Obstetrical Hemorrhag e   Neonatal Depression   Duration of arrest at dilation ≥6 cm   0.65*   0.55*   0.52   0.52   Dilation percentile   0.93*   0.81*   0.60*   0.61*   Station percentile   0.82*   0.78*   0.61*   0.58*   *P<0.01 Bold P<0.01 for comparison to duration of arrest36
  • 37. ROC Nullipara with First Stage CS for Labor Disorder 37                                                          Sensi'vity      False  posi've    Likelihood  Ra'o   >  4  hrs.                        12.2                            0.6                                        20.4    
  • 38. ROC Nullipara with First Stage CS for Labor Disorder 38                                                      Sensi'vity      False  posi've    Likelihood  Ra'o   <10th  percen2le            69.3                          4.9                                      14.2   <  5th  percen'le              43.6                            1.7                                      26.3  
  • 39. Labor Progress Assessment Time Curves Arrest Criteria • Static “One size fits all” • Applicable in late labor only • Pass/fail criteria for labor disorders • Weak association with labor related interventions Adaptive Models • Adjusts for multiple factors, adaptive •  Applicable from 3 cm onward •  Finely graded assessment •  Strong association with labor related interventions 39
  • 40. Acknowledgments Antonio Ciampi PhD Mathematics Gabrielle Simoneau MSc Mathematics Philip Warrick PhD Engineering Bruno Bendavid BSc Comp Sci Ebi Kimanani PhD Mathematics Samuel Smith MD Kathleen Collins RN Thomas Garite MD 40
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