induction of labor: past, present, and futurerayburn wf, wapner rj, barss va, spitzaberg e, molina...

Induction of Labor: Past, Present, and Future James O’Brien, MD Medical Director of Inpatient Obstetrics Women & Infants Hospital of Rhode Island

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Induction of Labor Past

Present

Future

National Perinatal Information Center

January 23, 2019

• I have no disclosures

Disclosures

• Identify origins and evolution of modern

labor inductions

• Describe current indications and methods

of labor inductions

• Examine the findings and assess the

implications of the ARRIVE trial

Objectives

History of Induction

• Hippocrates(2BC) - descriptions of mammary

stimulation and mechanical dilation of the cx

• 1810 – first reference of membrane sweeping

• 1861 – Barnes use of rubber water filled balloon

• 1909 – first report on use of posterior pituitary

extract for PP hemorrhage by Bell – As use expanded to IOL complications noted due to large dose

and impurities with method discredited due to uterine rupture

• Mechanical cx dilation used in 1930’s to expedite VD in

emergencies.

– As safety improved used for IOLs

Earliest Reports

• Use of post-pituitary extract in physiologic

amounts in OB – BMJ 1948

– IOL method using quinine followed by ‘pituitrin’ drip –

safe and successful in 50 to 60% of cases at term

• Synthesis of an octapeptide amide with

hormonal activity of oxytocin – J Am Chem Soc

1953 (du Vigneault)

– Chronicles first synthesis of

polypeptide hormone

– Same potency as ‘natural

oxytocin’

1940’s – 1950’s

• Foley catheter use for IOL in 1967

– 26Fr Foley w 50mL balloon; ambulation allowed;

AROM after expulsion Embrey RT, Mollison P. BMJ 1967

• Prostaglandin use began in 1960’s

– Growing literature in the 1970’s with use of IV, vaginal

and oral PGE2 and PGF2a.

– PGE2 insert FDA approved in 1995

• Use of laminaria and hygroscopic mechanical

dilators in 1980’s

– Laminaria with increased infectious morbidity

1960’s onwards

Increase in IOL Rates

Rate of IOL doubled between 1989 and 1997

with further 40% increase in last 20 years

National Vital Statistics, CDC

Increase in IOL Rates

National Vital Statistics, CDC

Methods & Process

Induction and Cervical

Ripening

• Original publication in 1964

amidst intense controversy

regarding EIOL

• Felt differing results were

based on patient selection &

proposed method as a tool

• Felt IOL was only to be used as elective

intervention and any factor that increased

risk to the PG was contraindication

Cervical Ripening

Cx Assessment/Bishop score

Bishop EH. Pelvic Scoring for Elective Induction. Obstet

Gynecol 1964;24:266-8.

• Required multiparity & recommended no

EIOL until PG within 3 weeks of term

• Eligible pts had cx exam in last wk of PG

as ‘guide to determining proximity to

spontaneous labor’

• Favorable score > 9

• Method could be used t

to more accurately

date for EIOL & ERCS

Cervical Ripening

Cx Assessment/Bishop score

• Alternatives proposed

– Cervical length vs % effacement

– 10 point system of Burnett (1966) scoring all 5

elements 0 to 2

• 3 element system with doubled weighting to cx

dilation (Lange et al. 1982)

– Prediction of inducibility

• Latency time

• Duration of labor

– Ability for AROM, not parity, key

factor to success

Cervical Ripening

Cx Assessment/Scoring Systems

Lange AP, Secher NJ, Westergard JG, Skovgard AI,

Stat C. Prelabor evaluation of inducibility. Obstet

Gynecol 1982;60:137-47.

• Attempt to determine if simplified 3-element

score would have same or increased predictive

value for VD

• Original Bishop score created on empiric basis &

logistic regression applied

• Dilation, station & effacement

had statistical significance and

3 highest regression coefficients

• WIH now uses simplified Bishop score

– Scores of > 5 (nullip): > 3 (multip) with cx dilation of >

3cm for EIOL

Cervical Ripening Cx Assessment/Simplified Bishop score

Laughton SK, Zhang J,Troendle J, Sun L,

Reddy UM. Using a Simplified Bishop Score to

Predict Vaginal Delivery. Obstet Gynecol

2011;117:805-11

• Impact of development and implementation of

guidelines for EIOL

• Pre-requisite Bishop score of > 8 (nullip) & > 6

(multip) for EIOL

• Results

– Decrease in overall IOL rate (24.9 to 16.6%, p<.001)

– Decrease in EIOL rate (9.1 to 6.4%, p<.001)

– Decrease in CS nullip EIOLs (34.5 to 13.8%, p =.01)

• Significant cost and LOS reductions noted as

result of guideline changes

IOL Process

Pre-requisite Bishop scores for EIOL

Fisch JM, English D, Pedaline S, Brooks K, Simhan

HN. Labor Induction Process Improvement. Obstet

Gynecol 2009;113:797-803

• Comparison of accuracy of transvaginal US vs

Bishop score in prediction of VD within 24h of

IOL

– Best cut-off point for prediction of successful IOL was

28mm (Bishop score of 3)

– Cx length < 19 mm deliver within 24h; > 31 mm have

84% chance of remaining undelivered

– Cx length a better predictor than Bishop score

• Sensitivity 0.87 vs 0.58; specificity 0.71 vs 0.77

Cervical Assessment

Ultrasound Measurement

Pandis GK, Papageoghiou AT, Ramanthan VG, Thompson MO, Nicolaides KH. Preinduction sonographic

measurement of cervical length in the prediction of successful induction of labor. Ultasound Obstet

Gynecol 2001;18:623-8.

Induction Process

Triage/Priority of Indications

• Cochrane Review (2005) included 22 trials

(2,797 women)

– Associated with reduced frequency of PG continuing

beyond 41 wks (RR 0.59, CI 0.46 to 0.74) an 42 wks

(RR 0.28, CI 0.15 to 0.50)

– To avoid 1 formal IOL membrane sweeping must be

performed in 8 patients

– Routine sweeping from 38 wks does not seem to

produce clinical important benefits

– One study evaluated GBS with no additional risk

found, but study too small to rule out effect

Membrane Sweeping/Stripping

Boulvain M, Stan CM, Irion O. Membrane sweeping for induction of

labour. Cochrane Database of System Rev 2005;1:CD000451.

• Balloon expulsion in 90% of pts w/i 12 hrs

– Average time for expulsion = 6.1 hrs

• Mean duration of labor to delivery time = 12.8hrs

– Balloon insertion to delivery interval = 21.2 hrs

– 94% of pts delivered within 36 hrs of insertion

• Most studies show Foley with better cx change

& shorter time interval to delivery than PG

• Some studies remove Foley at pre-designated

time; others wait for it to dislodge

Cervical Ripening

Mechanical Methods – Foley Balloon

Sherman DJ, Frenkel E,Tovbin J, Arieli S, Caspi E, Bukovsky I. Ripening of

Unfavorable Cervix with Extraamiotic Balloon Catheter: Clinical Experience and

Review. Ob Gyn Surv 1996.

• Inflation effect on cx dilation(3 cm) – 81.6% with

80 mL vs 57.7% with 30 mL

– Shorter IOL to delivery interval in primips

– Increased deliveries within 24 h in primips

– Decreased oxytocin requirements in primips

• Foley catheter use with TOLAC

– No specific ACOG recommendations; SOGC may use

– Uterine rupture rates – SL 0.45%; Foley 0.76%; IOL

without cx ripening 0.74%; PGE2 gel 2.9%

– OR for rupture with cx ripening 3.92; miso OR = 25;

Foley OR = 6.5

Cervical Ripening

Mechanical Methods

Gelber S, Sciscione A. Mechanical Methods of Cervical

Ripening and Induction of Labor. Clin Ob Gyn. 2006

• Randomized trial w 18F Foley inflated to either

30 mL(95 pts) or 60 mL(100 pts)

– Higher rates of delivery within 12h especially with

nulliparous women (p = .04) and greater dilation at

removal (3 vs. 4 cm, p < .01)

– No difference in median time to delivery, deliveries

within 24h and frequency of CD

Cervical Ripening

Mechanical Methods – Foley Balloon

Delaney S, Shafffer BL, Cheng YW, Vargas

J, Sparks TN, Paul K, Caughey AB. Labor

Induction with a Foley Balloon Inflated to 30

mL Compared with 60 mL. Obstet Gynecol

2010;115:1239-45

• Prospective randomized trial using single- (145 pts) vs

double-balloon (148 pts) catheters

– Both single-balloon & double-balloon devices equally efficacious

for IOL (insertion to del time 19.4 & 19.1h)

– Spontaneously expulsion of catheter had shorter time to delivery

& lower proportion of operative deliveries

Cx Ripening - Mechanical Methods

Foley Balloon vs. Double Balloon

Salim R, Zafran N, Nachum Z, Garmi G, Kraiem

N, Shalev E. Single-Balloon Compared with

Double-Balloon Catheters for Induction of Labor.

Obstet Gynecol 2011;118:79-86

• Mixed results in trials of Foley with

concurrent oxytocin

– No impact on time to delivery

– Change in Bishop score from 2.4 to 10.1 in 4h

• 77.8% expulsion rate by 4h and 83.3% VD rate

• Mixed results with Foley and extra-

amniotic saline infusion (EASI)

Cervical Ripening

Mechanical Methods + Other Agents

Lyndrup J. Induction of labour by balloon catheter with EASI:

a randomised comparison with PGE2 vaginal pessaries Eur

J Obstet Gyn Repro Biol 1994

Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC.

Transcervical Foley Catheter with and without Oxytocin for

Cervical Ripening. Obstet Gynecol 2008;111:1320-6

• Extensively studies with different agents, doses

and routes of administration without consensus

as to optimal approach

• PGs should effect physical and biochemical

changes in cervix without excessive uterine

activity

– Dissociation of collagen fibers with

increase and alteration in

glycosaminoglycans

– PGE2 may result in enhanced

myometrial sensitivity to oxytocin

Cervical Ripening

Prostaglandins

• Current vehicles – gel and insert

– Historical routes – oral and suppository

• Ripening with PGE2 suppository vs. oxytocin vs.

placebo with patients with PROM

– Lower rate of CD with PGE2 followed by oxytocin vs

oxytocin alone

– Time to delivery 13.9h (PGE2) vs 16.3h (oxytocin)

with both regimens shorter than placebo

– No improvement in outcome was noted with delay of

IOL

Cervical Ripening

Prostaglandins – Dinoprostone (PGE2)

Ray DA, Garite TJ. Prostaglandin E2 for Induction of Labor with

PROM at Term. Am J Obstet Gynecol 1992;166:836-43

• RCT of PGE2 Pessary vs. placebo

– More likely to increase Bishop score by > 3,

change Bishop score to > 6 and trigger active

labor (68% v 15%, p < .001)

• Trial of PGE2 an PGF2a for IOL

– Insufficient data to make conclusions

• PGE2 insert by FDA approved in 1995

Cervical Ripening

Prostaglandins – Dinoprostone (PGE2)

Rayburn WF, Wapner RJ, Barss VA, Spitzaberg E, Molina RD, Mandsager N, Yonekura ML. An

Intravaginal Controlled-Release PGE2 Pessary for Cervical Ripening. Obstet Gynecol

1992;79:374-9

Kelly AJ et al. Vaginal PGE2 and PGF2a for Induction of Labor. Cochrane

Database Sys Rev 2003

• Meta-analysis review of misoprostol for cervical

ripening (8 trials, 966 pts) compared with other

PGs, oxytocin or placebo

– Lower CD rates (OR 0.67)(15% vs 21.5%, p=.02)

– Higher rate of vaginal delivery within 24h (OR 2.64)

– Higher incidence of tachysystole (OR 2.70)

– Reduced number of patients requiring oxytocin

– Mean interval from start of IOL to delivery 4.6h less

– 50 mcg dose with shorter insertion to delivery and

VD times of 5 and 7h compared to 25 mcg dose with

increased tachysystole but similar NN outcomes

Cervical Ripening

Prostaglandins – Misoprostol (PGE1)

Sanchez-Ramos L, Kaunitz AM, WearsRL, Delke I, Gaudier FL. Misoprostol for

Cervical Ripening: A Meta-Analysis. Obstet Gynecol 1997;89:633-42.

• Misoprostol vs. Other Agents

– Higher rate of tachysystole with misoprostol

• Oral vs. vaginal misoprostol

– Shorter time to delivery with vaginal but more

abnormal EFM

Cervical Ripening

Prostaglandins – Misoprostol (PGE1)

Improved Same Worse

PGE1/PGE2 gel

PGE1/PGE2 insert

PGE1/Oxytocin

Bracketed Times from Prostin

to LR Transfer

5

8

19

13

21

18

19

16

7

12

0

5

10

15

20

25

< 2 hrs

2 to 4 hrs

4 to 6 hrs

6 to 8 hrs

8 to 10 hrs

10 to 12 hrs

12 to 16 hrs

16 to 20 hrs

20 to 24 hrs

> 24 hrs

106 patients (91%)

71 patients (51%)

4 to 20 hrs 6 to 16

39 pts (28%)

8 – 12

Cervical Ripening

“We like to try all of our options before

using drugs to induce labor.”

• RCT with PGE2 gel vs placebo for 5

consecutive days

– Median 4 days to delivery in PGE2 group vs

10 days with placebo

• Outpatient vs. Inpatient Foley

– 9.6h reduction in LOS

– No difference in Bishop score, duration of

IOL, oxytocin dose, Apgars, UA cord pH

Cervical Ripening

Outpatient

Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GHC. Labor

Induction with Prostaglandin E1 Misoprostol Compared with Transcervical Foley Catheter in

an Outpatient vs. Inpatient Setting. Obstet Gynecol 2001;98:751-6

O’Brien JM, Mercer BM, Cleary NT, Sibai BM. Efficacy of outpatient induction

with low-dose intravaginal prostaglandin E2: A randomized, double-blind,

placebo-controlled trial. Am J Obstet Gynecol 1995;173:1855-9

• Ongoing debate as to optimal regimen, but

no debating costs

– Misoprostol 50 mcg tablet - $0.49 (74.4%)

– Misoprostol 100 mcg tablet - $0.98

– Cervidil (PGE2) insert - $385.63 (7.6%)

– Prostin (PGE2) suppository - $2,208.12

– Foley catheter – $11.00 (80.1%)

– Cook double-balloon device - $41.25

– Utah double-balloon device - $42.36

Cervical Ripening Agents

Cost

• Clinical labor starts when uterine activity reaches

between 80 and 120MVUs

• Typical labor pattern

– Baseline of 8 to 12 mm Hg

– Ctx 25 to 50 mm Hg (3 to 5 ctx/10 min)

• Uterine hyperactivity > 250 MVUs

• Baseline hypertonus

– Weak – 12 to 20 mm Hg

– Moderate – 20 to 30 mm Hg

– Strong - > 30 mm Hg

Physiology of Uterine Contractions

Caldeyro-Barcia R et al. Physiology of

Uterine Contractions. Clin Obstet

Gynecol 1960

• Two types of oxytocin receptors –

myometrial and decidual

• Myometrial receptors increase with

increasing GA

– Increase slowly between 20 and 30 weeks

– Stable period from 34 weeks

– Rapid increase just prior to labor at term

– Decreased sensitivity after 40 weeks

Induction of Labor

Oxytocin Physiology

Brindley BA, Sokol RJ. Induction and augmentation of

labor: Basis and Methods for Clinical Practice. Ob

Gyn Surv 1988;43:730-41.

• Misconception of half-life of 3 to 4 minutes

informed early methods of treatment

– Time to reach steady state generally accepted as

approximately 4 half-lives and resulted in dosage

intervals of 15 to 20 minutes

• Seitchik et al. found steady state concentration

reached at 40 to 60 min (42 min)

– Also found variations of plasma oxytocin levels to

produce effective ctx among patients

– Seitchik & Castillo proposed dosage intervals of 30

minutes

Induction of Labor

Oxytocin Pharmacokinetics

Brindley BA, Sokol RJ. Induction and augmentation of

labor: Basis and methods for clinical practice. Ob Gyn Surv

1988;43:730-41.

Seitchik J, Amico J, Robinson AG, Castillo M. Oxytocin augmentation of

dysfunctional labor IV. Oxytocin pharmacokinetics Am J Obstet Gynecol

1984;150:225-8.

• Uterine activity

– After reaching maximum efficiency further increases

in oxytocin results in slowing or interruption of

myometrial blood flow & accumulation of metabolites

– Decrease in effective magnitude of uterine pressure

• Cervical dilation rate

– Rate of approximately 1cm/h in active labor

• Fetal Response

– Intermittent decrease or interruption in blood flow to

intervillous space impacting fetal oxygen during

contractions

Induction of Labor

Oxytocin Management Principles

Brindley BA, Sokol RJ. Induction and augmentation of labor:

Basis and methods for clinical practice. Ob Gyn Surv

1988;43:730-41.

• Study of impact of uterine activity on fetal oxygen status

and FHR patterns

– 56 healthy nullip patients with EIOL evaluated retrospectively

over 30 minutes with different levels of uterine activity

– Assessment of fetal oxygen status using FSpO2 sensor

Induction of Labor

Oxytocin Fetal Impact

< 5 ctx in 10 m

5 ctx in 10 m

> 6 ctx in 10 m

20% decrease in FSpO2

in Group 1

29% decrease in FSpO2

In Group 2

Simpson KR, James DC. Effects of oxytocin-

induced hyperstimulation during labor on fetal

oxygen status and fetal heart rate patterns.AmJ

Obstet Gynecol 2008;199:34.e1-34.e5.

• Optimal initial oxytocin dose, interval and frequency of

dosage increase, and methods of infusion are subject of

considerable debate

• Meta-analysis of 11 trials with 1,699 patients (840 low-

dose/859 high-dose) – Low-dose - fewer episodes of tachysystole (OR 0.41, CI 0.33-0.52)

– Low-dose – higher rate of SVD (OR 1.67, CI 1.27-2.20)

– Low-dose – fewer OVDs (OR 0.58, CI 0.40-0.83)

– Low-dose – trend toward lower CD rate (OR 0.78, CI 0.60-1.02)

– Also lower rates of PP maternal infection and PPH in low-dose group

• Conclusion: Although ideal regimen not known, IOL with minimal

dose of oxytocin to achieve active labor and increasing intervals

no more frequently than 30 minutes, is appropriate

Induction of Labor

Oxytocin Protocols

Crane JMG, Young DC, Meta-analysis of low-dose vs. high-dose

oxytocin for labour induction. J Soc Obstet Gynaecol Can

1998;20(13):1215-23.

• Randomized, double-masked comparison of oxytocin dosage in IOL.

Merrill DC, Zlatnik FJ. Obstet Gynecol 1999;94:455-63. – Low-dose -1.5mU/m increased by 1.5mU/m every 30m

– High-dose – 4.5mU/m increased by 4.5mU/m every 30m

– Time to full dilation and delivery decreased in high-dose group by approx 2h

with decreased cost of care

• Labor induction with continuous low-dose oxytocin infusion: a

randomized trial. Mercer BM, Pilgrim P, Sibai BM. Obstet Gynecol

1991;77:659-63.

– 2 regimens with oxytocin increased every 60m or 20m

– Lower incidence of CD in low-dose group (13.1% vs 30.7%, p = .02)

– Shorter time to active labor, full dilation and delivery for VDs in high-dose

group (4.5h vs 6.9h, 10.7h vs 12.2h, 11.4h vs 13.2h)

– Overall time from admission to delivery shorter in low-dose group (13.2h vs

20.5h)

Induction of Labor

Oxytocin Protocols

• A prospective comparison of hourly and quarter-hourly oxytocin

dose increase intervals for induction of labor at term. Blakemore KJ,

Nai-Geng Q, Petrie RH, Paine LL. Obstet Gynecol 1990;75:757-61.

– No statistically significant differences for duration of any stage of labor,

quantitative assessment of uterine activity, incidence of hyperstimulation or NN

outcome

• High- vs Low-Dose Oxytocin for Labor Stimulation. Satin AJ, Leveno

KJ, Sherman L, Brewster DS, Cunningham FG. Obstet Gynecol

1992;80:111.6. – AUGMENTATION STUDY

– Prospective study of low-dose (1mU/m increments) vs high-dose (6mU/m

increments) in singleton cephalic PGs

– Labor stimulation > 3h lower in high-dose (p<.0001)

– Reduction in NN sepsis in high-dose (0.2 vs 1.3%, p<.01)

– Failed IOL less frequent

– Shorter time in LR

Induction of Labor

Oxytocin Protocols

Conclusion: high-dose oxytocin for

IOL is potentially problematic but in

contrast for augmentation may

reduce rate of CD for dystocia

Induction of Labor

Oxytocin Checklist

• Conservative oxytocin checklist

develop and introduced at HCA

hospitals

• Max oxytocin dose decreased

13.8 to 11.4mU/m (p=.003)

• No change in time to delivery

• CD rate decreased from 23.6 to

21.0% system-wide

• Every index of NN outcome

improved but did not reach

statistical significance Clark S, Belfort M, Saade G, Hankins G, Miller D,

Frye D, Meyers J. Implementation of a conservative

checklist –based protocol for oxytocin administration :

maternal and newborn outcomes. Am J Obstet

Gynecol 2007;197:480.e1-480.e5.

Induction of Labor

IOL Times vs. Spontaneous Labor

Type of Delivery Mean LOS (days) Median LOS(days)

IOLs

Cesarean Deliveries 4.73 4.2

Vaginal Deliveries 3.18 2.82

Non-IOLs



Differences



Type of Delivery Mean (hrs) Median (Hrs)

IOLs - LR 15.89 13.2

IOLs – ACU 11.5 9.88

Total IOL Time 27.39 23.08

Labor – VDs 10.77 9.77

Difference - LR Bed Time 5.12 3.43

Difference – Total Bed Time 16.62 13.31

Labor – PCS 13.08 9.31

Difference 2.81 3.89

Labor – RCS 11.84 4.08

Difference 4.05 9.12

Induction of Labor

IOL Times vs. Spontaneous Labor

Time Lines (Mean)

Indication No CS

Rate

ACU

(hrs)

LR

(hrs)

MBU (hrs) LOS (days)

HTN 50 24% 35.85 18.43 55.14 4.46

HTN* 46 24% 18.93 18.44 53.85 3.78

Late Term 46 23.9% 11.79 14.06 50.18 3.12

PROM 32 18.8% 9.18 15.26 49.57 3.35

DM 19 15.8% 17.99 14.23 44.68 3.01

Oligo 16 6.3% 19.0 16.46 42.06 3.36

NRFT 13 30.8% 9.79 14.16 51.39 3.22

Elective 11 9.1% ----- 27.97 40.28 2.31

FGR 11 27.3% 19.31 17.2 57.01 3.79

Chol 5 20% 22.1 20.6 49.47 3.89

Misc 8 12.5% 16.18 16.02 48.36 3.2

All IOLs 16.04 15.89 3.35

* Removal of 3 outliers with long antepartum stay prior to IOL

• Cost differential for IOL by method of

delivery

– 2013 and 2017 cost analyses

WIH Data

IOL Costs

Year VD CS

2013 + $1,468 + $3,521

2017 + $2,068 + $4,187

Induction Outcomes Recent Studies

• Elective IOL at term compared with EM. Darney BG et

al. Obstet Gynecol 2013;122:761-9.

– Retrospective cohort all deliveries in CA in 2006

– Odds of CD lower with EIOL vs EM across all GAs from 37

through 40 weeks

• Maternal and NN outcomes in electively induced low-risk

term PGs. Gibson KS et al. Am J Obstet Gynecol

2014;211:249.31-6

– Retrospective cross-sectional study from Consortium for Safe

Labor (12 US institutions – 19 hospitals) 2002 through 2008

healthy TSV PGs 37 through 41 weeks

– Same results as Darney study

– Suggested entry criteria for ARRIVE trial be revised to include

lower GA patients

EIOL vs EM

ARRIVE Trial A Randomised Trial of Induction versus

Expectant Management

• Purpose: Assess perinatal and maternal

consequences of IOL at 39 weeks

gestation in low risk nulliparous women

• Methods: Random assignment to IOL

between 39’0 and 39’4 weeks or EM

– Primary outcome: composite of perinatal

death or severe NN complications

– Secondary outcome: CS rate

– 3,062 women to IOL; 3,044 women to EM

Abstract

• Results

– Primary outcome in 4.3% in IOL group and

5.4% of EM group (RR 0.80, CI 0.64 to 1.00)

– Secondary outcome in 18.6% of IOL group

and 22.2% of EM group (RR 0.84, CI 0.76 to

0.93)

• Conclusions

– IOL at 39 weeks did not result in lower

frequency of composite adverse NN events,

but did result in decreased frequency of CD

Abstract

• Prior conclusions re: CS rates flawed in

that spontaneous labor patients were used

as control group vs. IOL

• Trial was conducted by the MFMU network

as a multicenter RCT at 41 participating

hospitals

• Consented women were low-risk NTSV

with no C/I to vaginal delivery and reliable

dating

Background & Participants

• GA at delivery

– IOL 39.3 weeks (interquartile range 39.1 to 39.6)

– EM 40.0 weeks (interquartile range 39.3 to 40.7)

• Modified Bishop score at randomization

Results

• Significantly less likely to have HTN

disorders of PG – (9.1% vs. 14.1%; RR 0.64; CI 0.56 to 0.74); p<0.001)

• IOL patients spent more time in labor

and delivery unit, but had a shorter PP

LOS

IOL Group Results

• 6 additional hours of LR Bed Occupancy for IOL

patients

• 0.04 day difference in LOS (62 minutes)

LR Bed Occupancy/LOS

* applied 1.72 days (mean LOS for WIH

admissions < 2 days in IOL and non-IOL

patients)

IOL Group EM Group

< 2 days* 553.84 545.24

2 days 4,382 4,168

3 days 1,197 1,356

4 days 520 664

>4 days N/A N/A

Total Days 6,652.84 6,733.24

Average LOS 2.19 days 2.23 days

LOS Total Hours

• No significant difference in primary PN

outcome, but CD rate with unfavorable

cx improved (modified Bishop score < 5)

Cesarean Delivery

• Surprising finding considering existing literature

with higher CD with unfavorable cx

IOL Group Results

• 1,471 patients eligible for EIOL (Undelivered NTSV at 39’0 weeks & no IOL)

Operational Impact

Potential ARRIVE Projections

FY 19 ^

Deliveries

Inductions

(Rate)

Add 20%

(294 pts)

Add 40%

(588 pts)

Add 60%

(883 pts)

Add 80%

(1,177pts)

Annual 8,425 2,592

(30.8%)

2,886

(34.3%)

3,180

(37.7%)

3,475

(41.2%)

3,769

(44.7%)

Monthly 702.1 216 239 265 290 314

Daily 23.1 7.1 7.9 8.7 9.5 10.3

^ based on projected 2% decrease in deliveries from FY18 to FY 19

Potential ARRIVE Admissions

Add 20%

(294 pts)

Add 40%

(588 pts)

Add 60%

(883 pts)

Add 80%

(1,177 pts)

Additional Bed

Occupancy (hrs)

1,764 3,528

5,298

6,702

Additional

LR Bed

Time

• Study used ELICIT – a computerized

preference elicitation tool

– 91% of PG women stated a preference for VD

& would accept 59-75% chance of CD before

choosing a planned CD

– Need for oxytocin, antibiotics or OVD resulted

in lower scores, comparable to those

assigned to uncomplicated CD

– Shows importance of patient education about

process of labor and delivery and IOL

Management Challenges

Shared Decision Making

Mode of delivery preferences in a diverse population of pregnant

women. Yee LM et al.Am J Obstet Gynecol 2015

• Specific survey tool to assess patient’s

impression of IOL process using both pre-

and post-IOL

– Women described minimal dialogue with their

clinicians and expressed desire for more

information re: risk and benefits – cited

Listening to Mothers II and III Surveys

– Survey mentioned maternal concerns re: lack

of informed decision making and cited

opportunities for improvement


Shared Decision Making

Moving toward patient-centered decision care: Women’s decisions, perceptions and experiences of

the induction of labor process. Moore JE et al. Birth 2014;41(2):138-46


Ensuring an Adequate Trial of Labor

• Evidence shows progressively lower rates

of VD with longer duration of latent phase

– 40% of women who remained in LP after 12h

or oxytocin with ROM had VD Failed Labor Induction: Toward an Objective Diagnosis. Rouse DR et al. Obstet Gynecol 2011;117:267-72

• ACOG Care Consensus – Safe Prevention

of Primary Cesarean Delivery March 2014


Ensuring an Adequate Trial of Labor

• Implementation of ACOG recommendations

studied with significant decrease in CD rates – PCD rate from 9.4 to 6.9% (OR 0.71, CI 0.59-0.85, p<.01)

– CD rate for 1st stage arrest from 1.8 to 0.9% (OR 0.51, CI 0.31-0.81,

p<.01) Significant only for nulliparous women

– Median duration of labor significantly longer before PCD(120m), 1st

stage CD(180m),2nd stage CD(120m), failed IOL(300m)

Impact of recommended changes in labor

management for prevention of primary

cesarean delivery. Thullier C et al. Amer J

Obstet Gynecol 2018;218:341.e1-9

● Labor Progression Study (LaPS), Bernitz et al (2018) ○ This study looked at the frequency of intrapartum cesarean section

(ICS) in active labor using the WHO Partograph vs. Zhang’s guideline ○ 7,277 woman at 14 different obstetrics units ○ No difference in ICS rate between groups,

but decreased CS rate overall


Use of Directive Tools

ICS Rate Prior to Study ICS Rate During Study

WHO Partogram 9.5% 5.9%

Zhang Guideline 9.3% 6.8%

Bernitz S et al. (2018) The frequency of intrapartum casearean section use with the WHO partograph

versus Zhang’s guideline in Labour Progression Study (LaPS): A multicentre, cluster randomised

controlled trial. Lancet

• Cesarean delivery after EIOL: The

physician effect. Luthy DA et al. Am J

Obstet Gynecol 2004

– Individual MD has a contributing effect to

increased CS risk (OR 1.78)

– May be related to individual MD patient

selection or variation in diagnosis of arrest

disorder, failed IOL or NR fetal status

IOL Outcomes

Physician Effect

Questions

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