indicated labor induction phase one: protocol development peter cherouny, m.d. university of vermont...

Indicated Labor Induction Indicated Labor Induction Phase One: Protocol Phase One: Protocol

DevelopmentDevelopment

Peter Cherouny, M.D.University of Vermont Department of OB/GYN

Indicated Labor Induction Indicated Labor Induction Phase One: Protocol DevelopmentPhase One: Protocol Development

ObjectivesObjectives– After the presentation the participant will be After the presentation the participant will be

able to:able to:

– Articulate the risks of proposed obstetric care to the Articulate the risks of proposed obstetric care to the patientpatient

– Incorporate the risks of care into patient care Incorporate the risks of care into patient care discussionsdiscussions

– Recognize the absolute level of risk of fetal death at Recognize the absolute level of risk of fetal death at termterm



To Induce or not to InduceSetting the Stage

The Cost of OxytocinThe Cost of Oxytocin

The Real Cost of OxytocinThe Real Cost of Oxytocin

The costs to the patient from coming to The costs to the patient from coming to us for care:us for care:

Safety Risk and CostSafety Risk and Cost

Focus on the group with the highest Focus on the group with the highest variability for Primary Cesarean deliveryvariability for Primary Cesarean delivery

(by provider or institution)(by provider or institution)

Term IUPTerm IUP

Cephalic presentationCephalic presentation

No contraindications for labor/vaginal No contraindications for labor/vaginal deliverydelivery



First term pregnancies (without prior labor)First term pregnancies (without prior labor)

Multiparous term with a prior vaginal deliveryMultiparous term with a prior vaginal delivery

The Intention is to treat these women with The Intention is to treat these women with vaginal deliveryvaginal delivery

How many patients are there?How many patients are there?



How many of our patients?How many of our patients?– 70% deliver vaginally70% deliver vaginally 70%70%– 70% primary cesarean sections70% primary cesarean sections 21%21%

have indications that did not have indications that did not 91%91%

preclude laborpreclude labor

Failure to induce, dilate or descendFailure to induce, dilate or descend

elective cesareanelective cesarean



RememberRemember

The Intention is to treat these women with The Intention is to treat these women with vaginal deliveryvaginal delivery

Our 91%erOur 91%er

Because we have pitocin, we…Because we have pitocin, we…

(Term IUP, cephalic presentation, no labor)(Term IUP, cephalic presentation, no labor)

Induce laborInduce labor (25%)(25%)-10% elective IOL-10% elective IOL


(Term IUP, cephalic presentation, no labor)(Term IUP, cephalic presentation, no labor)

Augment laborAugment labor (30%)(30%)– Induction vs augmentationInduction vs augmentation

What’s your definitionWhat’s your definition

By Delivery TypeBy Delivery Type

Term IUP, cephalic presentationTerm IUP, cephalic presentation

Spon laborVaginal Delivery

Pitocin laborVaginal Delivery or C/S

Spo

n La

bor

Ces

area

n S

ectio

n

By Labor TypeBy Labor Type


Spon labor

Pitocin Labor

Cesarean SectionVaginal Delivery



Induce or Augment labor (55-90%)Induce or Augment labor (55-90%)– What’s the patient pitocin exposure in your What’s the patient pitocin exposure in your

L&D?L&D?


Term IUP, cephalic presentation, no laborTerm IUP, cephalic presentation, no labor

Induce laborInduce labor (25%)(25%)– Increase nursing timeIncrease nursing time

1:2 for active labor1:2 for active labor

– Increase provider timeIncrease provider timein hospital in active laborin hospital in active labor

– Increase analgesia useIncrease analgesia use90% with IOL, 100% with OVD90% with IOL, 100% with OVD


Term IUP, cephalic presentation, no laborTerm IUP, cephalic presentation, no labor

Induce laborInduce labor (25%)(25%)– Increase OVDIncrease OVD

2-3 fold Relative Risk2-3 fold Relative Risk

– Increase cesarean sectionsIncrease cesarean sections2-3 fold Relative Risk2-3 fold Relative Risk

– Increase general anesthesiaIncrease general anesthesia5% of cesarean sections5% of cesarean sections

– Increase NICU admissionsIncrease NICU admissions2-4 fold RR at Term2-4 fold RR at Term



Induce or Augment labor leading to C/SectionInduce or Augment labor leading to C/Section– Increase postpartum hemorrhageIncrease postpartum hemorrhage

RR 1.4-2.3RR 1.4-2.31-6% requiring transfusion1-6% requiring transfusion

– Increase postoperative DVT/PEIncrease postoperative DVT/PECommon cause of maternal mortalityCommon cause of maternal mortality

– Increase hospitalization (nosocomial infection, etc.)Increase hospitalization (nosocomial infection, etc.)– Increase AFE (amniotic fluid embolus)Increase AFE (amniotic fluid embolus)

– 3-4 fold RR after IOL3-4 fold RR after IOL– 12 fold RR after Cesarean section12 fold RR after Cesarean section



Induce or Augment labor leading to C/SectionInduce or Augment labor leading to C/Section– Increase postpartum/cesarean hysterectomiesIncrease postpartum/cesarean hysterectomies

3 fold RR of placenta previa after 1 cesarean section3 fold RR of placenta previa after 1 cesarean section45 fold RR after 4 or more prior Cesarean deliveries45 fold RR after 4 or more prior Cesarean deliveries5 fold RR for placenta accreta after 1 Cesarean delivery5 fold RR for placenta accreta after 1 Cesarean delivery11 fold RR with 2 prior Cesarean deliveries11 fold RR with 2 prior Cesarean deliveries0.25% (1987); 0.82% (2006)0.25% (1987); 0.82% (2006)

– Increase time of recoveryIncrease time of recovery3-4 vs 1-2 days for initial recovery3-4 vs 1-2 days for initial recovery

– Increase costs to business (time away and insurance)Increase costs to business (time away and insurance)



Induce or Augment labor leading to C/SectionInduce or Augment labor leading to C/Section– Increase antibiotic exposureIncrease antibiotic exposure

5-10 fold RR5-10 fold RR– Increased fetal injuryIncreased fetal injury

1-2% at Cesarean Section1-2% at Cesarean Section– Increase organ injuryIncrease organ injury

2% at cesarean delivery2% at cesarean delivery5% at hysterectomy5% at hysterectomy

– Increased abdominal scarringIncreased abdominal scarringSmall Bowel Obstruction 0.5/1000Small Bowel Obstruction 0.5/1000



Induce or Augment labor leading to C/SectionInduce or Augment labor leading to C/Section– Increased ectopic pregnanciesIncreased ectopic pregnancies– Increased narcotic use/abuseIncreased narcotic use/abuse– Increased infertilityIncreased infertility

1.5 RR of infertility after cesarean delivery1.5 RR of infertility after cesarean delivery

– Increased time to first breastfeedingIncreased time to first breastfeeding– Decreased bondingDecreased bonding– Decreased birth experienceDecreased birth experience

Joint Commission Sentinel Event Joint Commission Sentinel Event Alert Issue #44Alert Issue #44

Causes of maternal deathCauses of maternal death

%%PreeclampsiaPreeclampsia 1616

Amniotic fluid embolism Amniotic fluid embolism 1414

Obstetric hemorrhage Obstetric hemorrhage 1212

Cardiac disease Cardiac disease 1111

Pulmonary thromboembolism Pulmonary thromboembolism 9 9

Clark et al. Maternal death in the 21st century: causes, prevention, and relationship to cesarean delivery. AJOG;199:36.


Relationship between route of delivery and Relationship between route of delivery and maternal deathmaternal death

VaginalVaginal 1.7 1.7

Primary Cesarean Primary Cesarean 16.316.3

Repeat Cesarean Repeat Cesarean 7.4 7.4

Total Cesarean Total Cesarean 12.712.7

Totals Totals 6.5 6.5



Causal relationship between route of Causal relationship between route of delivery and maternal deathdelivery and maternal death

VaginalVaginal 0.2 0.2

Primary Cesarean Primary Cesarean 2.5* 2.5*

Repeat Cesarean Repeat Cesarean 1.1 1.1

Total Cesarean Total Cesarean 2.0 2.0**

Totals Totals 1.4 1.4*p<0.001 for VD*p<0.001 for VD


Why don’t we feel these Why don’t we feel these numbers…numbers…

*Absolute numbers are low*Absolute numbers are low

*Relative Risks are low*Relative Risks are low

**2-4 times a low number is still a low 2-4 times a low number is still a low number. number.


*Absolute numbers are low*Absolute numbers are low**Obstetrician doing 300 del/yrObstetrician doing 300 del/yr

-100 CS-100 CS-75 IOL-75 IOL

**Home birth midwifeHome birth midwife-100 deliveries/year-100 deliveries/year

*10-fold increased maternal death rate*10-fold increased maternal death rate--Obstetrician would take 5-10 years to have Obstetrician would take 5-10 years to have

1 death1 death-Midwife would take 10-15 years to have 1 -Midwife would take 10-15 years to have 1

deathdeath


*Absolute numbers are low*Absolute numbers are low**Obstetrician doing 300 del/yrObstetrician doing 300 del/yr

-100 CS-100 CS-75 IOL-75 IOL

**Home birth midwifeHome birth midwife-100 deliveries/year-100 deliveries/year

*5-fold increased neonatal death rate*5-fold increased neonatal death rate--Obstetrician would take 6-12 months to Obstetrician would take 6-12 months to

have 1 deathhave 1 death-Midwife would take 18 months to have 1 -Midwife would take 18 months to have 1

deathdeath

Oxytocin Costs SummaryOxytocin Costs Summary

4.3 million USA deliveries (2007)4.3 million USA deliveries (2007)

X 25% induction rate = X 25% induction rate =

1.08 million Labor Inductions1.08 million Labor Inductions

X 31.3% Cesarean Section Rate =X 31.3% Cesarean Section Rate =

1.31 million Cesarean Sections1.31 million Cesarean Sections

– Even low incidence outcomes become importantEven low incidence outcomes become important

Balancing MeasureBalancing Measure

Fetal DeathFetal Death

MacDorman MF, Hoyert DL, Martin JA, Munson ML, Hamilton BE. Fetal and Perinatal Mortality, United States, 2003. National vital statistics reports; vol 55 no 6. Hyattsville, MD: National Center for Health Statistics. 2007.


Perinatal Mortality ratePerinatal Mortality rate– Fetal MR + Neonatal MRFetal MR + Neonatal MR

Fetal MR represents 58% of the PMRFetal MR represents 58% of the PMR

FMR 6.23 in 2003FMR 6.23 in 2003– 51% of Fetal Mortality occurs at 20-27 wks51% of Fetal Mortality occurs at 20-27 wks

FMR at 28+ weeks is 3.0FMR at 28+ weeks is 3.0

– 80.3% of Fetal Mortality occurs prior to term80.3% of Fetal Mortality occurs prior to termFMR at term is 1.2FMR at term is 1.2

Fetal Death – A Primer




Fetal Death

2

2.5

3

3.5

4

4.5

5

5.5

1985 1990 1995 2000 2003

20-27 wks

28+ wks


Oshiro et al. Decreasing Elective Deliveries Before 39 Weeks of Gestation in an Integrated Health Care System. Obstet Gynecol 2009;113:804–11)

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

37 38 39 40 41 ALL

Pre-Study

Study

Fetal Death

Our 91%erOur 91%er0



To Induce or not to InduceSetting the Stage

The Reliability Design StrategyThe Reliability Design Strategy

Prevent initial failure Prevent initial failure – intent and standardization functionintent and standardization function

Identify failure (defects) and mitigateIdentify failure (defects) and mitigate– Redundancy functionRedundancy function

Measure and then communicate learning from Measure and then communicate learning from defectsdefects– Redesign functionRedesign function

Why Standardize?Why Standardize?

Contributes to building an infrastructure (who does what, Contributes to building an infrastructure (who does what, when, where, how and with what) when, where, how and with what)

Support training and competency testing to sustain the Support training and competency testing to sustain the processprocess

Achieve front line articulation of key processes by staffAchieve front line articulation of key processes by staff

Allows the appropriate application of Evidence Based Allows the appropriate application of Evidence Based Medicine consistentlyMedicine consistently

Feedback about errors and application of learning to Feedback about errors and application of learning to design is possibledesign is possible

The Clinical Bundle as StandardizationThe Clinical Bundle as Standardization

What is a Clinical BundleWhat is a Clinical Bundle

A group of clinical events that should happen every time a A group of clinical events that should happen every time a given process occursgiven process occurs

Individual elements based on solid scienceIndividual elements based on solid science

Emphasis initially on process rather than outcomeEmphasis initially on process rather than outcome

Based on failure modesBased on failure modes

Eventual endpoint is outcome improvementEventual endpoint is outcome improvement

Quality Care in ObstetricsQuality Care in Obstetrics Elective Labor Induction-RequirementsElective Labor Induction-Requirements

Elective Oxytocin Labor Induction BundleElective Oxytocin Labor Induction Bundle Gestational age Gestational age >> 39 weeks 39 weeks Category I EFMCategory I EFM Absence of tachysystole with increases in Absence of tachysystole with increases in

pitocin/Response to tachysystolepitocin/Response to tachysystole Pelvic assessmentPelvic assessment

Quality Care in ObstetricsQuality Care in Obstetrics Augmentation-RequirementsAugmentation-Requirements

Oxytocin Augmentation BundleOxytocin Augmentation Bundle Estimated fetal weightEstimated fetal weight Category I and some Category II EFMCategory I and some Category II EFM Absence of tachysystole with increases in Absence of tachysystole with increases in

pitocin/Response to tachysystolepitocin/Response to tachysystole Pelvic AssessmentPelvic Assessment

Quality Care in ObstetricsQuality Care in Obstetrics

Indicated Labor Induction BundleIndicated Labor Induction BundleDefined: Defined: Patient with a medical indication for Patient with a medical indication for

inductioninductionAcceptable medical indication for labor induction Acceptable medical indication for labor induction documented (locally defined)documented (locally defined)Pelvic Assessment Pelvic Assessment Recognition and management of complications of Recognition and management of complications of induction method (including tachysystole) induction method (including tachysystole) Recognition and management of FHR StatusRecognition and management of FHR Status

– Exclusion of Category III FHR Exclusion of Category III FHR

ReferencesReferencesAl-Took S, Platt R, Tulandi T. Adhesion-related small-bowel obstruction after Al-Took S, Platt R, Tulandi T. Adhesion-related small-bowel obstruction after gynecologic operations. Am J Obstet Gynecol. 1999;180:313-315.gynecologic operations. Am J Obstet Gynecol. 1999;180:313-315.Hemminki E. Impact of cesarean section on future pregnancy -- a review of cohort Hemminki E. Impact of cesarean section on future pregnancy -- a review of cohort studies. Paediatr Perinat Epidemiol. 1996;10:366-379.studies. Paediatr Perinat Epidemiol. 1996;10:366-379.Murphy DJ, Stirrat GM, Heron J, et al; ALSPAC Study Team. The relationship Murphy DJ, Stirrat GM, Heron J, et al; ALSPAC Study Team. The relationship between caesarean section and subfertility in a population-based sample of 14,541 between caesarean section and subfertility in a population-based sample of 14,541 pregnancies. Hum Reprod. 2002;17:1914-1917. pregnancies. Hum Reprod. 2002;17:1914-1917. Lydon-Rochelle M, Holt VL, Martin DP, Easterling TR. Association between method of Lydon-Rochelle M, Holt VL, Martin DP, Easterling TR. Association between method of delivery and maternal rehospitalization. JAMA. 2000;283:2411-2416 delivery and maternal rehospitalization. JAMA. 2000;283:2411-2416 Rowe-Murray HJ, Fisher JR. Operative intervention in delivery is associated with Rowe-Murray HJ, Fisher JR. Operative intervention in delivery is associated with compromised early mother-infant interaction. BJOG. 2001;108:1068-1075. compromised early mother-infant interaction. BJOG. 2001;108:1068-1075. E. Sheiner, L. Esarid, A. Levy and D.S. Hallak, Obstetric risk factors and outcome of E. Sheiner, L. Esarid, A. Levy and D.S. Hallak, Obstetric risk factors and outcome of pregnancies complicated with early postpartum hemorrhage: A population-based pregnancies complicated with early postpartum hemorrhage: A population-based study, study, J Matern Fetal Neonatal MedJ Matern Fetal Neonatal Med 18 (2005), pp. 149–154 18 (2005), pp. 149–154 Clark et al. Maternal death in the 21st century: causes, prevention, and relationship to Clark et al. Maternal death in the 21st century: causes, prevention, and relationship to cesarean delivery. AJOG;199:36.cesarean delivery. AJOG;199:36.


Patient-based causes of maternal deathPatient-based causes of maternal death

– Existing medical conditionsExisting medical conditionsObesityObesity

– Preeclampsia Preeclampsia – Amniotic Fluid EmbolismAmniotic Fluid Embolism– Pulmonary EmbolismPulmonary Embolism



Causal relationship between route of Causal relationship between route of delivery and maternal death excluding delivery and maternal death excluding PEPE

VaginalVaginal 0.2 0.2Primary Cesarean Primary Cesarean 2.5 2.5Repeat Cesarean Repeat Cesarean 1.1 1.1Total Cesarean Total Cesarean 2.0 2.0Totals Totals 1.4 1.4Clark et al. Maternal death in the 21st century: causes, prevention, and relationship to

cesarean delivery. AJOG;199:36.

P=0.07

P=0.38

P=0.08

PERFORMANCE

Indi

vidu

al A

uton

omy

Guidelines as defined by professional standards Legal space

Usual spaceof action

Illegal-normalspace

the ‘illegal-illegal’ space (for almost all of us!)

VE

RY

UN

SA

FE

SP

AC

E IndividualPressures

PerceivedVulnerability

Belief inSystems-guidelines

<1% 5% 50% 80% 100% percent of staff

Safety regs & good practices

Certification/ accreditation

standards

Collective memory of experiences

Forbiddenbehavior except under extreme circumstances

Forbiddenby all

55 in a 55

65 in a 55

85 in a 55

105 in a 55

indicated labor induction phase one: protocol development peter cherouny, m.d. university of vermont...

Documents

term slide

labor type term iup

active labor

cost slide

laborvaginal delivery

labor failure

elective cesarean slide

ovd slide