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WILLIAM GROBMAN, MD,MBAARTHUR HALE CURTIS PROFESSORDEPARTMENT OF OBSTETRICS AND
GYNECOLOGYFEINBERG SCHOOL OF MEDICINE
NORTHWESTERN UNIVERSITY
The evidence-based case to induce all normal pregnancies at 39 weeks
GOU, 2017
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When is the best time for delivery?
Delivery Expectant management
≥ 42 weeks < 39 weeks
39 - 41 weeks41 weeks
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Increasing maternal and perinatal risks after 39 weeks
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Maternal Complications
● Pregnancies that continue beyond 39 weeks are associated with increased risks of: ○ Cesarean delivery○ Operative vaginal delivery○ 3rd and 4th degree lacerations○ Febrile morbidity○ Hemorrhage
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Statistical significance as compared to rate of cesarean delivery in the previous week gestation*p<.05
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Statistical significance as compared to rate of outcome in the previous week gestation: *p<.05
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Perinatal Complications
● Pregnancies that continue beyond 39 weeks are associated with increased risks of:○ Stillbirth○ Meconium aspiration syndrome○ Mechanical ventilation○ Birth trauma○ Neonatal seizures/ICH/ encephalopathy○ Neonatal sepsis○ UA pH ≤7/BE < -12
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Severe Neonatal Complications
40 vs. 39 weeks: adjusted OR 1.47 (1.1, 2.0)41 vs. 39 weeks : adjusted OR 2.04 (1.5, 2.78)
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Induction and cesarean delivery:Common wisdom
● Retrospective cohort studies ○ Induction of labor prior to 41 weeks of gestation
is associated with an approximately 2-fold higher risk of cesarean delivery in nulliparous women
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39 weeksN= 100
CS rate=20%N=6
IOL
CS rate=30%N=35
30% Spontaneous laborat 39 weeks
CS rate=30%N=11
50% labor at 40 weeks
CS rate=40%N=14
35
N=100
Medical or Post dates IOL
70
CS rate=31%
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Induction vs. Expectant Management
Week of Induction
IOL Spontaneous
38 weeks 11.9% 7.0%
39 weeks 14.3% 9.1%
40 weeks 20.4% 10.9%
41 weeks 24.3% 14.9%
Caughey et al, AJOG 2006;195:700-5
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Induction vs. Expectant Management
Week of Induction
IOL Spontaneous Expectant aOR (95% CI)
38 weeks 11.9% 7.0% 13.3% 1.80 (1.29-2.53)
39 weeks 14.3% 9.1% 15.0% 1.39 (1.08-1.80)
40 weeks 20.4% 10.9% 19.0% 1.24 (1.27-1.62)
41 weeks 24.3% 14.9% 26.0% 1.26 (0.99-1.61)
Caughey et al, AJOG 2006;195:700-5
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EIOL vs. expectant management at 39 weeks
%
Cheng et al AJOG 2012; Stock et al BMJ 2012
Cesarean delivery
10% decreased odds of cesarean in EIOL group
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Cesarean delivery with EIOL
%
Osmundson et al, Obstet Gynecol 2010 & 2011
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RCTs?
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Induction vs. Expectant Management
○ RCT of women at 41 weeks of gestation (N = 3407)
Hannah et al, NEJM, 1992
%
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RCT of EIOL prior to 41 weeks –Until 2016….
●Only small RCT’s●None have found an increased in cesarean
delivery○ Poor quality○ Underpowered
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Walker et al, NEJM 2016
● 619 nulliparous women ● Age 35 years or older● Randomized between 36 weeks and 39 6/7 weeks
%
Cesarean Delivery
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Walker et al, NEJM 2016
●Only women aged 35 or older●No idea about cervical status●UK system very different (e.g., OVD)●Underpowered for perinatal outcomes
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Perinatal outcomes with EIOL?
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EIOL vs. expectant management at 39 weeks
%
Cheng et al AJOG 2012; Stock et al BMJ 2012
Perinatal mortality and morbidity
70% decreased odds of mec aspiration and mortality, respectively, in EIOL group
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IOL vs. expectant management
CMAJ2014
NICU admission: RR 0.86, 95% CI 0.79 – 0.94
Fetal death: RR 0.50, 95% CI 0.25 – 0.99
Maternal death: RR 1.00, 95% CI 0.1 – 9.57
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Resource utilization
●Osmundson et al, 2010/2011○ Labor induction
• Favorable cervix: 3.7 additional L&D hours• Unfavorable cervix: 3.8 additional L&D hours
●Vijgen, BJOG 2010 (Hypitat)○ Total costs 11% less for IOL (€831)
DOES NOT ACCOUNT FOR ANTEPARTUM COSTS
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Resource utilization
● Walker et al, BJOG 2017○ Induction cheaper by £236 and increases QALY by .002
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A RANDOMIZED TRIAL OF INDUCTION VERSUS
EXPECTANT MANAGEMENT
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A RANDOMIZED TRIAL OF INDUCTION VERSUS
EXPECTANT MANAGEMENT
(ARRIVE)
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Inclusion criteria
● Nulliparous● Singleton gestation● Adequate dating
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Protocol
● Randomization between 38-38 6/7 to:○ Elective induction of labor between 39 and 39 4/7 weeks○ Expectant management
● Cervical exam at randomization
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IOL Group
● Favorable: oxytocin ● Unfavorable: cervical ripening followed by oxytocin
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Expectant Management
● Unless a medical indication is present, will continue pregnancy until at least 40 5/7 weeks of gestation
● Antepartum fetal testing (per institutional protocol) always will be initiated no later than 41 weeks for all ongoing pregnancies
● All patients delivered no later than 42 2/7 weeks
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Primary Perinatal Outcome
Composite of neonatal morbidity and perinatal mortality● Antepartum, intrapartum, or neonatal death● Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiorespiratory support within first 72 hours ● Apgar ≤ 3 at 5 minutes ● Neonatal encephalopathy ● Seizures ● Sepsis● Meconium aspiration syndrome● Birth trauma (bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, facial nerve injury)● Intracranial hemorrhage or subgaleal hemorrhage● Hypotension requiring pressor support
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Secondary Outcomes
● Secondary outcomes○ Maternal morbidity
• Cesarean delivery • Operative vaginal delivery• 3rd/4th degree perineal lacerations• Infection• Postpartum hemorrhage
○ NICU admissions○ Utilization of health care resources○ Patient-reported outcomes (control of experience, pain)
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Power Analysis - Primary Perinatal Outcome
Expectant management group: 3.5%
Effect size: 40%
Power: 80%
Sample size = 3000 per group
Recruitment completed August 2017
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?