Adapted from slides by

Elective Delivery Prior to 39 Elective Delivery Prior to 39 Weeks: Weeks:

Peter Cherouny, M.D.Peter Cherouny, M.D.University of Vermont College of MedicineUniversity of Vermont College of MedicineDepartment of Obstetrics and GynecologyDepartment of Obstetrics and Gynecology

Adapted from slides by Adapted from slides by

How we can work to lower this How we can work to lower this number to zero!number to zero!

Original ACOG GuidelinesOriginal ACOG GuidelinesLate Preterm Deliveries & Early Term DeliveriesLate Preterm Deliveries & Early Term Deliveries

Original Guidelines for Original Guidelines for Confirmation of Term Gestation Confirmation of Term Gestation (ACOG 1988)(ACOG 1988)

Fetal heart tones have been documented for 20 weeks by Fetal heart tones have been documented for 20 weeks by nonelectronic fetoscope or for 30 weeks by Doppler. nonelectronic fetoscope or for 30 weeks by Doppler.

It has been 36 weeks since a positive serum or urine human It has been 36 weeks since a positive serum or urine human chorionic gonadotropin pregnancy test was performed by a chorionic gonadotropin pregnancy test was performed by a reliable laboratory. reliable laboratory.

An ultrasound measurement of the crown. rump length, An ultrasound measurement of the crown. rump length, obtained at 6-12 weeks, supports a gestational age of at least obtained at 6-12 weeks, supports a gestational age of at least 39 weeks. 39 weeks.

An ultrasound obtained at 13-20 weeks confirms the gestational An ultrasound obtained at 13-20 weeks confirms the gestational age of at least 39 weeks determined by clinical history and age of at least 39 weeks determined by clinical history and physical examination. physical examination.

Amniocentesis and documentation of fetal maturityAmniocentesis and documentation of fetal maturity

Current ACOG GuidelinesCurrent ACOG GuidelinesLate Preterm Deliveries & Early Term Deliveries Late Preterm Deliveries & Early Term Deliveries

Current guidelines for Assessing Fetal Maturity (ACOG Current guidelines for Assessing Fetal Maturity (ACOG Prac Bull #97; August 2008)Prac Bull #97; August 2008)

Fetal heart tones have been documented Fetal heart tones have been documented for 20 weeks by for 20 weeks by nonelectronic fetoscope ornonelectronic fetoscope or for 30 weeks by Doppler for 30 weeks by Doppler

It has been 36 weeks since a positive serum or urine human It has been 36 weeks since a positive serum or urine human chorionic gonadotropin pregnancy test chorionic gonadotropin pregnancy test was performed by a was performed by a reliable laboratory. reliable laboratory.

Ultrasound measurement at less than 20 weeks of gestation Ultrasound measurement at less than 20 weeks of gestation supports gestational age of 39 weeks or greater supports gestational age of 39 weeks or greater

Amniocentesis and documentation of fetal maturityAmniocentesis and documentation of fetal maturity

Current ACOG Guidelines Current ACOG Guidelines Late Preterm Deliveries & Early Term Deliveries Late Preterm Deliveries & Early Term Deliveries

Current guidelines for Assessing Fetal Maturity (ACOG Current guidelines for Assessing Fetal Maturity (ACOG Prac Bull #97; August 2008)Prac Bull #97; August 2008)

Ultrasonography may be considered to confirm menstrual dates Ultrasonography may be considered to confirm menstrual dates if there is a gestational age agreement within 1 week by crown–if there is a gestational age agreement within 1 week by crown–rump measurements obtained in the first trimester rump measurements obtained in the first trimester

An ultrasound obtained in the second trimester at up to 20 An ultrasound obtained in the second trimester at up to 20 weeks by multiple biometeric parameters confirms the weeks by multiple biometeric parameters confirms the gestational age of at least 39 weeks within 10 days.gestational age of at least 39 weeks within 10 days.

Are the guidelines appropriate?Are the guidelines appropriate?The EvidenceThe Evidence

Small retrospective data from various groupsSmall retrospective data from various groups More detailed retrospective data setsMore detailed retrospective data sets Large retrospective cohort studies from detailed perinatal Large retrospective cohort studies from detailed perinatal

databases with specific cohort identitiesdatabases with specific cohort identities Very large cohort studies with clear inclusion and Very large cohort studies with clear inclusion and

exclusion criteria more appropriate for the focused exclusion criteria more appropriate for the focused questions askedquestions asked


1284 elective cesarean deliveries1284 elective cesarean deliveries Relative risks of pulmonary complication (TTN + RDS)Relative risks of pulmonary complication (TTN + RDS)

2.6 overall vs VD2.6 overall vs VD

5.85 for RDS vs VD5.85 for RDS vs VD

12.912.9 37+0-38+6 vs 37+0-38+6 vs >> 39+0 39+0

Zanardo V, Simbi AK, Franzoi M, Solda G, Salvadori A, Trevisanuto D. Neonatal respiratory morbidity risk and mode of delivery at term: influence of timing of elective caesarean delivery. Acta Paediatr 2004;93:643–

7.


7.

Are the guidelines appropriate?Are the guidelines appropriate?The Evidence The Evidence

Delivery room careDelivery room care ( (nn, %), %) Elective CSElective CS VDVD Apgar 5 at 1 min Apgar 5 at 1 min 21 (1.6%) 21 (1.6%) 13 (1.0%) 13 (1.0%) NICU admission NICU admission 17 (1.3%) 17 (1.3%) 8 (0.6%) 8 (0.6%)**

RDS (RDS (nn)) 29 29 5 5 2.6 (1.35–5.9)*2.6 (1.35–5.9)*

37 0–38 6 (wk) 37 0–38 6 (wk) 25 25 2 2 12.9 (3.57–35.53)*12.9 (3.57–35.53)*

39 0–41 6 (wk) 39 0–41 6 (wk) 4 4 3 3 1.15 (0-17–5.3)1.15 (0-17–5.3)

*overall difference between the groups*overall difference between the groups


7.


13,258 Elective Sections13,258 Elective Sections 35.8% less than 39 weeks35.8% less than 39 weeks

• 29.5% at 38 wks29.5% at 38 wks

• 6.3% at 37 wks6.3% at 37 wks

Tita ATN, et al. Eunice Kennedy Shriver NICHD Maternal–Fetal Medicine Units Network Timing of Elective Repeat Cesarean Delivery at Term and Neonatal Outcomes. NEJM 360 (2) 2009. 111-120.


13,258 Elective Sections13,258 Elective Sections 35.8% less than 39 weeks35.8% less than 39 weeks

• 29.5% at 38 wks29.5% at 38 wks

• 6.3% at 37 wks6.3% at 37 wks

Primary outcome variable was a composite of neonatal death and any of Primary outcome variable was a composite of neonatal death and any of several adverse events, including respiratory complications, treated several adverse events, including respiratory complications, treated hypoglycemia, newborn sepsis, and admission to the neonatal ICUhypoglycemia, newborn sepsis, and admission to the neonatal ICU


35.8% less than 39 weeks


13,258 Elective Sections13,258 Elective Sections

GAGA 3737 3838 3939

RRRR 2.12.1 1.51.5 1.01.0




0

10

20

30

40

50

37 38 39 40 41 42+

% pop

Inc POV


More likely to be delivered at less than 39 More likely to be delivered at less than 39 weeks if:weeks if:

OlderOlder ThinnerThinner Non-Hispanic WhiteNon-Hispanic White MarriedMarried Diet controlled GDMDiet controlled GDM Non LGA fetusNon LGA fetus INSUREDINSURED


Late Preterm DeliveriesLate Preterm Deliveries& Early Term Deliveries & Early Term Deliveries

Are the guidelines appropriate?Are the guidelines appropriate? All term singleton live births in the US in 2003 All term singleton live births in the US in 2003

(cephalic, no prior C/S, not pre or postterm)(cephalic, no prior C/S, not pre or postterm) Gestational age at delivery by completed week from Gestational age at delivery by completed week from

37-41 weeks37-41 weeks Outcomes: Primary C/S, OVD, febrile morbidity, Outcomes: Primary C/S, OVD, febrile morbidity,

macrosomia, neonatal injury, 5’ Apgar, HMD, MAS, macrosomia, neonatal injury, 5’ Apgar, HMD, MAS, mechanical ventilation > 30 minutesmechanical ventilation > 30 minutes

Cheng YW , et al. Perinatal outcomes in low-risk term pregnancies: do they differ by week of gestation? AJOG 2008;199:370


All term singleton live births in the US in All term singleton live births in the US in 20032003

2,527,766 deliveries2,527,766 deliveries




0

0.1

0.2

0.3

0.4

0.5

0.6

37 38 39 40 41

HMD

Vent>30'


Wilminck et al. Neonatal outcome following elective cesarean section beyond 37 weeks Wilminck et al. Neonatal outcome following elective cesarean section beyond 37 weeks of gestation: a 7-year retrospective analysis of a national registry. AJOG;of gestation: a 7-year retrospective analysis of a national registry. AJOG;202:250250

GAGA 3737 3838 3939 4040 4141POV ORPOV OR 2.42.4 1.41.4 1.01.0 0.90.9 1.011.01


Donovan et al. Infant death among Ohio resident infants born at 32-41 weeks Donovan et al. Infant death among Ohio resident infants born at 32-41 weeks of gestation. AJOG 2010;203:58.e1-5.of gestation. AJOG 2010;203:58.e1-5.

411,560 deliveries reviewed411,560 deliveries reviewed

GAGA 3737 3838 3939Infant Mort Rate ORInfant Mort Rate OR 1.91.9 1.41.4 1.01.0


Moster et al. Cerebral palsy among term and postterm births. Moster et al. Cerebral palsy among term and postterm births. JAMA. 2010;304(9):976-982. 1.68 million births, 37-44 weeks without congenital anomalies

GAGA 3737 3838 3939CP RRCP RR 1.9 (1.6-2.4) 1.3 (1.1-1.5) 1.1 (1.0-1.3)

GA 40 41 42CP RR 1 (Reference) 1.1 (1.0-1.2) 1.4 (1.2-1.6)


Moster et al. Cerebral palsy among term and postterm births. Moster et al. Cerebral palsy among term and postterm births. JAMA. 2010;304(9):976-982. 1.68 million births, 37-44 weeks without congenital anomalies

00.20.40.60.8

11.21.41.61.8

2

37 38 39 40 41 42

CP RR

Are the guidelines appropriate?Are the guidelines appropriate?

The ACOG guidelines written in 1988 and The ACOG guidelines written in 1988 and reaffirmed in 2008 appear appropriate for the reaffirmed in 2008 appear appropriate for the state of the sciencestate of the science

Late Preterm DeliveriesLate Preterm Deliveries& Early Term Deliveries& Early Term Deliveries

Why do we still see over one-third of elective Why do we still see over one-third of elective deliveries performed prior to 39 completed deliveries performed prior to 39 completed weeks?weeks?

Pressure from patientsPressure from patients Individual experience not large enough to see a Individual experience not large enough to see a

difference in outcomedifference in outcome Unfamiliarity with the new dataUnfamiliarity with the new data No strict hospital based guidelinesNo strict hospital based guidelines


Current InterventionsCurrent Interventions

– Educational programsEducational programs– Audit/feedback programsAudit/feedback programs– Quality improvement projectsQuality improvement projects– Visiting expertsVisiting experts

...have limited impact on improving clinical care...have limited impact on improving clinical care

Possible SolutionsPossible Solutions

Interventions aimed at systems Interventions aimed at systems improvement have a greater impactimprovement have a greater impact

-patients under 39 weeks will not be -patients under 39 weeks will not be scheduled for scheduled for elective delivery elective delivery “Hard Stop”“Hard Stop”

-develop an elective delivery check list -develop an elective delivery check list for use on L&Dfor use on L&D

Does It Work?Does It Work?

Ohio Perinatal Collaborative Ohio Perinatal Collaborative reduced inappropriate ear;y term deliveries prior to 39 reduced inappropriate ear;y term deliveries prior to 39

weeks from 25% to <5%.weeks from 25% to <5%.

The Ohio Perinatal Quality Collaborative writing committee. A statewide initiative to reduce inappropriate The Ohio Perinatal Quality Collaborative writing committee. A statewide initiative to reduce inappropriate scheduled births at 36+0-38+6 weeks’ gestation.scheduled births at 36+0-38+6 weeks’ gestation.

Elective Deliveries <39 Weeks Intermountain Healthcare

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Elective Deliveries <39 Weeks Intermountain Healthcare

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And what can be:

How?How?

Identify and develop a set of specific and Identify and develop a set of specific and measurable changes that you can implement in measurable changes that you can implement in order to achieve improvement in elective order to achieve improvement in elective deliveriesdeliveries

NYSDOH Key DriversNYSDOH Key Drivers1.1. Awareness of risks/expected benefit of late Awareness of risks/expected benefit of late

preterm an early term delivery by patients and preterm an early term delivery by patients and consumersconsumers

2.2. Dating criteria: optimal estimation of gestational Dating criteria: optimal estimation of gestational ageage

3.3. Hospital and physician practice policies that Hospital and physician practice policies that facilitate ACOG criteriafacilitate ACOG criteria

4.4. Awareness of risks/expected benefit of late Awareness of risks/expected benefit of late preterm and early term delivery by clinicianpreterm and early term delivery by clinician

5.5. Culture of safety and improvementCulture of safety and improvement NYSONQC OB Expert Work Group Webinar– July 12, 2010

1. Awareness of risks/expected benefit 1. Awareness of risks/expected benefit of near-term delivery by patients and of near-term delivery by patients and

consumersconsumers

Key Changes:Key Changes: Inform consumers of risks/benefits of delivery < Inform consumers of risks/benefits of delivery <

39 weeks39 weeks Communicate to patient/clinic/hospital Communicate to patient/clinic/hospital

dating/ultrasound resultsdating/ultrasound results Promote need for early dating to practitioners Promote need for early dating to practitioners

and consumersand consumers Public awareness campaign Public awareness campaign

NYSONQC OB Expert Work Group Webinar– July 12, 2010

2. Dating criteria: optimal 2. Dating criteria: optimal estimation of gestational ageestimation of gestational age

Key changes:Key changes: Promote need for early dating to practitioners and Promote need for early dating to practitioners and

consumers as appropriateconsumers as appropriate Develop/Document criteria used to establish EDCDevelop/Document criteria used to establish EDC Appropriate use of fetal maturity testingAppropriate use of fetal maturity testing Empower nurses/schedulers to require dating criteriaEmpower nurses/schedulers to require dating criteria Create/Identify administrative support for Create/Identify administrative support for

authorization dispute re: datingauthorization dispute re: dating

NYSONQC OB Expert Workgroup Webinar – July 12, 2010

3. Hospital and physician practice 3. Hospital and physician practice policies that facilitate ACOG criteriapolicies that facilitate ACOG criteria Key changes:Key changes: Empower nurses/schedulers to require dating criteriaEmpower nurses/schedulers to require dating criteria Document rationale and risk/benefit for scheduled deliveries Document rationale and risk/benefit for scheduled deliveries

at 36 1/7 to 38 6/7 weeks gestation at 36 1/7 to 38 6/7 weeks gestation Document discussion with patient about the aboveDocument discussion with patient about the above Both patient and MD sign consent statement for scheduled Both patient and MD sign consent statement for scheduled

delivery between 36 1/7 to 38 6/7 weeksdelivery between 36 1/7 to 38 6/7 weeks Physician awareness campaign: what are the indications for Physician awareness campaign: what are the indications for

scheduled delivery? scheduled delivery? Maximize access to Delivery and OR for optimal schedulingMaximize access to Delivery and OR for optimal scheduling Facilitate scheduling policies that respect ACOG criteriaFacilitate scheduling policies that respect ACOG criteria


4. Awareness of risks and expected benefit 4. Awareness of risks and expected benefit of near-term delivery by clinicianof near-term delivery by clinician

Key changes:Key changes: Prenatal caregivers receive feedback from postnatal Prenatal caregivers receive feedback from postnatal

caregivers about neonatal outcomes of scheduled caregivers about neonatal outcomes of scheduled deliveriesdeliveries

Ensure complete and accurate handoffs Ob/OB and Ensure complete and accurate handoffs Ob/OB and Ob/PedsOb/Peds

Document discussion with patient about risks/benefit Document discussion with patient about risks/benefit of late preterm/early term delivery of late preterm/early term delivery

• Promote need for early dating to practitioners and Promote need for early dating to practitioners and consumersconsumers


5. Culture of safety and 5. Culture of safety and improvement improvement

Key changes:Key changes: Continuous monitoring of data and discussion of this Continuous monitoring of data and discussion of this

effort in staff/division meetingseffort in staff/division meetings Post data-Project outcomesPost data-Project outcomes Develop ways to include staff and physician input Develop ways to include staff and physician input

about communications and handoffsabout communications and handoffs Connect with organizational initiatives on safety and Connect with organizational initiatives on safety and

use existing approaches as possibleuse existing approaches as possible Empower nurses/schedulers to require dating criteriaEmpower nurses/schedulers to require dating criteria Constant communication among multidisciplinary Constant communication among multidisciplinary

teamteamNYSONQC OB Expert Workgroup Webinar – July 12, 2010

Develop hospital-level measurement toolsDevelop hospital-level measurement tools Perform small tests of change in the hospital Perform small tests of change in the hospital Eventual result is widespread implementation of improvements Eventual result is widespread implementation of improvements

in practicesin practices Provide the methods for process improvementProvide the methods for process improvement Make it easy to complyMake it easy to comply Work the change into current work flowWork the change into current work flow

CommunicateCommunicate

Create the urgencyCreate the urgency

What do we need to do:What do we need to do:

Late Preterm DeliveriesLate Preterm Deliveries& Early Term Deliveries & Early Term Deliveries

Summary:Summary:

Late preterm/Early term delivery is increasingLate preterm/Early term delivery is increasing Early term deliveries have higher riskEarly term deliveries have higher risk Inadvertent deliveries prior to confirmation of fetal Inadvertent deliveries prior to confirmation of fetal

maturity are a preventable part of this increasematurity are a preventable part of this increase Validated guidelines exist for preventionValidated guidelines exist for prevention Adherence to guidelines can reduce inadvertent late Adherence to guidelines can reduce inadvertent late

preterm/early term deliveriespreterm/early term deliveries Gestational dating is keyGestational dating is key Hospital-specific system redesign and process Hospital-specific system redesign and process

improvement shows the largest impact on improvementimprovement shows the largest impact on improvement


Ehrenthal et al. Labor induction and the risk of cesarean delivery among Ehrenthal et al. Labor induction and the risk of cesarean delivery among nulliparous women at term. OBGYN 2010;116:35-42nulliparous women at term. OBGYN 2010;116:35-42

Kamath et al. Neonatal outcomes after elective cesarean delivery OBGYN Kamath et al. Neonatal outcomes after elective cesarean delivery OBGYN 2009;113:1231-82009;113:1231-8

The ohio perinatal quality collaborative writing committee. A statewide The ohio perinatal quality collaborative writing committee. A statewide initiative to reduce inappropriate scheduled births at 36+0-38+6 weeks’ initiative to reduce inappropriate scheduled births at 36+0-38+6 weeks’ gestation. 25% to <5%.gestation. 25% to <5%.

Wilminck et al. Neonatal outcome following elective cesarean section Wilminck et al. Neonatal outcome following elective cesarean section beyond 37 weeks of gestation: a 7-year retrospective analysis of a national beyond 37 weeks of gestation: a 7-year retrospective analysis of a national registry. Primary outcome 37-OR 2.4, 38-OR 1.4, 39-OR 1.0, 40-OR 0.9, registry. Primary outcome 37-OR 2.4, 38-OR 1.4, 39-OR 1.0, 40-OR 0.9, 41-OR 1.0141-OR 1.01

Donovan et al. Infant death among Ohio resident infants born at 32-41 Donovan et al. Infant death among Ohio resident infants born at 32-41 weeks of gestation. IMR 37-OR 1.9, 38-OR 1.4, 39-OR 1.0. from 40-weeks of gestation. IMR 37-OR 1.9, 38-OR 1.4, 39-OR 1.0. from 40-115,000 deliveries, total 411,560 reviewed.115,000 deliveries, total 411,560 reviewed.

Moster et al. Cerebral palsy among term and postterm births. Moster et al. Cerebral palsy among term and postterm births. JAMA. 2010;304(9):976-982. 1.68 million births, 37-44 weeks without congenital anomalies. 37- 37-1.9 (1.6-2.4), 38-1.3 (1.1-1.5), 39-1.1 (1.0-1.3), 40-1[Reference], 41-1.1 (1.0-1.2), 42-1.4 (1.2-1.6)

Documents

Adapted from slides by