Complications of Delivery Complications of Delivery Before 39 Weeks: Before 39 Weeks:

OB PerspectiveOB Perspective

Roger B. Newman MDRoger B. Newman MDMaas Endowed Chair For Reproductive SciencesMaas Endowed Chair For Reproductive Sciences

Professor and Vice-ChairmanProfessor and Vice-ChairmanDepartment of Ob-GynDepartment of Ob-Gyn

Medical University of South CarolinaMedical University of South Carolina

Complications of Delivery <39 WksComplications of Delivery <39 WksLearning ObjectivesLearning Objectives

• Rates of late-preterm birth in USRates of late-preterm birth in US

• Reasons for the increaseReasons for the increase

• Indications/contraindications for IOLIndications/contraindications for IOL

• Advantages/disadvantages of IOLAdvantages/disadvantages of IOL

• RecommendationsRecommendations

Preterm Birth in USPreterm Birth in US

• Has increased 20% in past 15 years: 10.6% in Has increased 20% in past 15 years: 10.6% in 1990 to 12.7% in 20051990 to 12.7% in 2005

• ““Late-Preterm” (34-36 weeks) increasing at a Late-Preterm” (34-36 weeks) increasing at a greater rate than other PTB subgroupsgreater rate than other PTB subgroups

• ““Late-Preterm” birth rate was 7.3% in 1990 vs Late-Preterm” birth rate was 7.3% in 1990 vs 9.1% in 2005; 25% increase9.1% in 2005; 25% increase

Delivery Indications: Delivery Indications: Late- Preterm BirthsLate- Preterm Births

Induction of LaborInduction of LaborUnited StatesUnited States

• Doubled from ’90 to ’06: 9.5% to 22.5%Doubled from ’90 to ’06: 9.5% to 22.5% Some for medical/Ob indicationsSome for medical/Ob indications Most: marginal or electiveMost: marginal or elective

• Why?Why? Better cervical ripening agentsBetter cervical ripening agents Patient/MD conveniencePatient/MD convenience Relaxed attitudes re: marginal indicationsRelaxed attitudes re: marginal indications Concerns re: fetal death with expect RxConcerns re: fetal death with expect Rx

CDC 2009; Rayburn, AJOG 2002; Moore, Clin Ob-Gyn 2006CDC 2009; Rayburn, AJOG 2002; Moore, Clin Ob-Gyn 2006

Accuracy of Vital Statistic DataAccuracy of Vital Statistic DataBirth CertificatesBirth Certificates

• Ohio Perinatal Quality Collaborative 2008Ohio Perinatal Quality Collaborative 2008

20 Ohio hospitals20 Ohio hospitals

• To decrease nonmedically-indicated scheduled To decrease nonmedically-indicated scheduled deliveriesdeliveries

• All scheduled deliveries: 36-38 6/7 wksAll scheduled deliveries: 36-38 6/7 wks

• Comparison of chart abstraction vs birth certificatesComparison of chart abstraction vs birth certificates

• 11% in BC vs 1% in chart11% in BC vs 1% in chart

Birth Certificate Data vs Chart Birth Certificate Data vs Chart Abstracted DataAbstracted Data

Bailit; Induction rates derived from birth certificate data. Am J Obstet Gynecol 2010Bailit; Induction rates derived from birth certificate data. Am J Obstet Gynecol 2010

Conceptual DiagramConceptual Diagram

Timing of Indicated Late-Timing of Indicated Late-Preterm and Early-Term BirthPreterm and Early-Term Birth

• Workshop Feb. 2011, sponsored by Eunice Workshop Feb. 2011, sponsored by Eunice Kennedy Shriver NICHD and SMFMKennedy Shriver NICHD and SMFM

• Synthesize available evidence regarding Synthesize available evidence regarding conditions resulting in medically-indicated conditions resulting in medically-indicated late-preterm or early-term birthslate-preterm or early-term births

• Based on available data and expert opinion, Based on available data and expert opinion, optimal timing for delivery was determined by optimal timing for delivery was determined by consensusconsensus

Spong, Mercer, D’Alton et al OBGYN, Spong, Mercer, D’Alton et al OBGYN,

20112011

Induction of LaborInduction of LaborContraindicationsContraindications

• Prior classical CSPrior classical CS

• Prior transmural uterine incisionPrior transmural uterine incision

• Placenta or vasa previaPlacenta or vasa previa

• Umbilical cord prolapseUmbilical cord prolapse

• Transverse lieTransverse lie

Induction of LaborInduction of LaborDisadvantagesDisadvantages

• Increased Cesarean rateIncreased Cesarean rate

• Iatrogenic prematurityIatrogenic prematurity

• CostCost

Induction of LaborInduction of Labor37-38 wks vs 37-38 wks vs ≥≥39 wks39 wks

• Prospective observational studyProspective observational study 18,000 deliveries in 27 HCA hospitals18,000 deliveries in 27 HCA hospitals 3 month epoch in 20073 month epoch in 2007

• Planned elective IOL: 31% of all deliveriesPlanned elective IOL: 31% of all deliveries

• PopulationPopulation 790 at 37-38 wks (28.3%)790 at 37-38 wks (28.3%) 2004 at 2004 at ≥≥39 wks (71.7%)39 wks (71.7%)

Clark, AJOG, 2009Clark, AJOG, 2009

Induction of LaborInduction of Labor37-38 wks vs 37-38 wks vs ≥≥39 wks39 wks

• Results: higher NICU adm (7.7 vs 3.0%)Results: higher NICU adm (7.7 vs 3.0%)

• Cesarean rates correlated with cx Cesarean rates correlated with cx dilatation in both nullips and multipsdilatation in both nullips and multips

• Term should no longer be 37 wksTerm should no longer be 37 wks

Clark, AJOG, 2009Clark, AJOG, 2009

Induction of LaborInduction of LaborNulliparityNulliparity

• Matched cohort of nullips, singleton, cephMatched cohort of nullips, singleton, ceph

• Population: BelgiumPopulation: Belgium 7683: elective IOL7683: elective IOL 7683: spontaneous labor7683: spontaneous labor

• 38-41 weeks38-41 weeks

• BW 3000-4000gmsBW 3000-4000gms

• Cervical status and ripening not knownCervical status and ripening not known

Cammu, AJOG 2002Cammu, AJOG 2002

Induction of LaborInduction of LaborNulliparityNulliparity

• Higher Cesarean: 10 vs 7% (1Higher Cesarean: 10 vs 7% (1stst stage problems) stage problems)

• Higher instrumental delivery: 32 vs 29%Higher instrumental delivery: 32 vs 29%

• More epidurals: 80 vs 58%More epidurals: 80 vs 58%

• More NICU: 11 vs 9%More NICU: 11 vs 9%

• Nullips should be informed before elective IOLNullips should be informed before elective IOL

Cammu, AJOG 2002Cammu, AJOG 2002

Induction of LaborInduction of LaborNulliparityNulliparity

• Retrospective cohort: Tacoma, WashRetrospective cohort: Tacoma, Wash

• Elective IOL (n=263)Elective IOL (n=263) Low risk at 38-41 wksLow risk at 38-41 wks Compared to spon laborCompared to spon labor

• Primary outcome: Cesarean OR 2.4, CI 1.2,4.9Primary outcome: Cesarean OR 2.4, CI 1.2,4.9

• Longer labor (4 hrs) and more cost ($273)Longer labor (4 hrs) and more cost ($273)

Induction of LaborInduction of LaborNulliparityNulliparity

• Multiple cohort studies: Cesarean rate Multiple cohort studies: Cesarean rate doubled for elective and medical inductionsdoubled for elective and medical inductions

• Primarily due to unfav cervix: Bishop Primarily due to unfav cervix: Bishop ≤5≤5

• RPT showed no diff in Cesarean with RPT showed no diff in Cesarean with favorable cx (Bishop ≥ 5)favorable cx (Bishop ≥ 5)

Nielsen, J Mat Fet Neo Med 2005Nielsen, J Mat Fet Neo Med 2005

Bishop’s ScoreBishop’s ScoreScoreScore DilatationDilatation   EffacementEffacement StationStation PositionPosition ConsistencyConsistency

00 closed closed  0 – 30%0 – 30% -3-3 posteriorposterior firmfirm    11 1-2 cm1-2 cm 40 -50%40 -50% -2-2 mid-positionmid-position moderately firmmoderately firm   22 3-4 cm3-4 cm 60 -70%60 -70% -1,0-1,0 anterior anterior Soft Soft    33 5+ cm5+ cm 80+%80+% +1,+2+1,+2

A point is added: Preeclampsia/Each prior vaginal delivery A point is added: Preeclampsia/Each prior vaginal delivery A point is subtracted: Postdates/Nulliparity/pPROM A point is subtracted: Postdates/Nulliparity/pPROM

Cesarean RatesCesarean Rates First Time MothersFirst Time Mothers Women with Past Vaginal DeliveriesWomen with Past Vaginal DeliveriesBS  0 - 3BS  0 - 3 45%45% 7.7% 7.7%BS 4 – 6BS 4 – 6 10% 10%  3.9% 3.9%BS 7 - 10BS 7 - 10 1.4%1.4% 0 .9% 0 .9%

Bishop’s ScoreBishop’s Score

Induction of LaborInduction of LaborNulliparityNulliparity

• Retrospective cohort: NorthwesternRetrospective cohort: Northwestern

• Elective IOL (n=294)Elective IOL (n=294) NullipNullip Bishop Bishop ≥ 5≥ 5 39-40 5/7 wks39-40 5/7 wks Compared to expectantly managedCompared to expectantly managed

• Primary Outcome: Cesarean ( 21 vs 20%)Primary Outcome: Cesarean ( 21 vs 20%)

• IOL: longer labor (13 vs 9 hrs)IOL: longer labor (13 vs 9 hrs)

Osmundson, ObstetGynecol, 2010Osmundson, ObstetGynecol, 2010

Induction of LaborInduction of LaborMultiparasMultiparas

• No increased Cesarean rateNo increased Cesarean rate

• Most data retrospective, but one small PRTMost data retrospective, but one small PRT

• Large population-based cohortLarge population-based cohort 1775 low risk multips at term IOL vs1775 low risk multips at term IOL vs 5785 similar pts with spon labor5785 similar pts with spon labor Cervical ripening agents if unripeCervical ripening agents if unripe Cesarean similar: 3.8 vs 3.6% (RR 1.07)Cesarean similar: 3.8 vs 3.6% (RR 1.07)

Nielsen, J Mat Fet Neo Med 2005; Dublin, AJOG 2000Nielsen, J Mat Fet Neo Med 2005; Dublin, AJOG 2000

Induction of LaborInduction of LaborRespiratory MorbidityRespiratory Morbidity

• 33,289 deliveries 33,289 deliveries ≥ 37 wks≥ 37 wks

• RDS or TTN requiring adm to NICURDS or TTN requiring adm to NICU

• Comparison with overall baseline term ratesComparison with overall baseline term rates

• Elective induction at term with vag delivElective induction at term with vag deliv 37-37 6/7: 12.6/1000, OR 2.5, CI 1.5-4.22 37-37 6/7: 12.6/1000, OR 2.5, CI 1.5-4.22 38-38 6/7: 7.0/1000, OR 1.4, CI 0.8-2.2 38-38 6/7: 7.0/1000, OR 1.4, CI 0.8-2.2 39-39 6/7: 3.2/1000, OR 0.6, CI 0.4-1.0 39-39 6/7: 3.2/1000, OR 0.6, CI 0.4-1.0

Morrison, BJOG, 1995Morrison, BJOG, 1995

Induction of LaborInduction of LaborRespiratory MorbidityRespiratory Morbidity

• Same comparison in failed IOL/CesareanSame comparison in failed IOL/Cesarean 37-37 6/7: 57.7/1000, OR 11.2, CI 5.4-13.137-37 6/7: 57.7/1000, OR 11.2, CI 5.4-13.1 38-38 6/7: 9.4/1000, OR 1.8, CI 0.6-5.938-38 6/7: 9.4/1000, OR 1.8, CI 0.6-5.9 39-39 6/7: 16.2/1000, OR 3.2, CI 1.4-7.439-39 6/7: 16.2/1000, OR 3.2, CI 1.4-7.4

• Elective delivery by Cesarean without labor: Elective delivery by Cesarean without labor: Increased freq at all gestational agesIncreased freq at all gestational ages

Morrison, BJOG 1995Morrison, BJOG 1995

Timing of Elective Repeat Timing of Elective Repeat CesareanCesarean

• MFMU Network: secondary analysis of MFMU Network: secondary analysis of Cesarean registryCesarean registry

• 19 academic centers 1999-200219 academic centers 1999-2002

• N=13,258 for elective term repeat CesareanN=13,258 for elective term repeat Cesarean 37 wks: 6.3%37 wks: 6.3% 38 wks: 29.5%38 wks: 29.5% 39 wks: 49.1%39 wks: 49.1%

Tita, NEJM, 2009Tita, NEJM, 2009

Timing of Elective Repeat Timing of Elective Repeat CesareanCesarean

• Composite outcome: respiratory, sepsis, Composite outcome: respiratory, sepsis, hypoglycemia, NICU admit, death hypoglycemia, NICU admit, death 37wks: 15.3%, OR 2.1, CI 1.7-2.537wks: 15.3%, OR 2.1, CI 1.7-2.5 38 wks: 11.0%, OR 1.5, CI 1.3-1.738 wks: 11.0%, OR 1.5, CI 1.3-1.7 39 wks: 8.0%39 wks: 8.0%

• Individual outcomes also signif differentIndividual outcomes also signif different

• No diff between 39 and 40 wksNo diff between 39 and 40 wks

• Increased morbidity at 41 wksIncreased morbidity at 41 wks

Tita, NEJM Tita, NEJM 20092009

Elective Repeat Cesarean Delivery & Elective Repeat Cesarean Delivery & Incidence of Primary OutcomeIncidence of Primary Outcome

Timing of Elective Repeat Timing of Elective Repeat CesareanCesarean

• 2-3 stillbirths avoided with delivery < 39 wks2-3 stillbirths avoided with delivery < 39 wks

• 176 extra cases of primary outcome176 extra cases of primary outcome

• 145 extra admissions to NICU145 extra admissions to NICU

• 63 extra cases of RDS63 extra cases of RDS

• Also increased morbidity 38 4/7-38 6/7Also increased morbidity 38 4/7-38 6/7

Tita, NEJM 2009Tita, NEJM 2009

Neonatal MorbidityNeonatal MorbidityElective CesareanElective Cesarean

• Elective Cesarean at term: breech, Elective Cesarean at term: breech, social, CPD, repeat, fundal scarsocial, CPD, repeat, fundal scar

• Amsterdam ’94-’98: n=324Amsterdam ’94-’98: n=324

• Decreased respiratory morbidity with Decreased respiratory morbidity with advancing gest age (p<0.05)advancing gest age (p<0.05) 37-37 6/7 wks:37-37 6/7 wks: 8.4%8.4% 38-38 6/7wks:38-38 6/7wks: 4.4%4.4% 39+ wks:39+ wks: 1.8%1.8%

van den Berg, EJOG, 2001van den Berg, EJOG, 2001

Economic ConsequencesEconomic ConsequencesDecision AnalysisDecision Analysis

• Cohort of 100,000 patientsCohort of 100,000 patients Induction at 39, 40, 41 wks vs expectant RxInduction at 39, 40, 41 wks vs expectant Rx All patients delivered by 42 wksAll patients delivered by 42 wks

• IOL at 39 weeksIOL at 39 weeks 12,000 excess Cesareans12,000 excess Cesareans Additional cost: $100 millionAdditional cost: $100 million 133 fetal deaths avoided133 fetal deaths avoided Regardless of cx ripeness or parityRegardless of cx ripeness or parity

Kaufman, AJOG, 2002Kaufman, AJOG, 2002

Decision AnalysisDecision Analysis

Kaufman, AJOG, 2002Kaufman, AJOG, 2002

• IOL less expensiveIOL less expensiveLater gestational agesLater gestational ages

MultipsMultips

Favorable cervixFavorable cervix

• Most costlyMost costlyNullips with unfavorable cervixNullips with unfavorable cervix

Cost halved with favorable cervix (Bishop > 5)Cost halved with favorable cervix (Bishop > 5)

Still overall added expenseStill overall added expense

Induction of LaborInduction of LaborBottom LineBottom Line

• No evidence for elective IOLNo evidence for elective IOL

• Need large randomized studiesNeed large randomized studies Maternal and neonatal safetyMaternal and neonatal safety Reduced unexplained fetal deathReduced unexplained fetal death Cost-effectivenessCost-effectiveness

Complications of Delivery <39 WksComplications of Delivery <39 WksFinal ThoughtsFinal Thoughts

• IOL only if continuing preg has greater IOL only if continuing preg has greater maternal/fetal risks than the interventionmaternal/fetal risks than the intervention

• No elective IOL at term without indicationsNo elective IOL at term without indications Increased Cesarean rateIncreased Cesarean rate Iatrogenic prematurityIatrogenic prematurity Increased costIncreased cost No proven benefitsNo proven benefits

• Bishop score best at predicting successBishop score best at predicting success

• Elective primary or repeat Cesarean < 39 weeks Elective primary or repeat Cesarean < 39 weeks inappropriate without indicationinappropriate without indication

• Term should now be considered 39 weeksTerm should now be considered 39 weeks