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Mar 23, 2023 21 likes •362 views

Fidelity to individual components of a standardized labor induction protocol and association with improved obstetric outcomes: a simplification strategy prior to large-scale implementation. Rebecca F. Hamm MD, Rinad S. Beidas PhD, Sindhu K.

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SLIDE 1

D e c e m b e r 6 , 2 0 1 9

Maternal & Child Health Research Center University of Pennsylvania

Fidelity to individual components of a standardized labor induction protocol and association with improved obstetric outcomes:

a simplification strategy prior to large-scale implementation.

12th Annual Conference on the Science of Dissemination and Implementation

Rebecca F. Hamm MD, Rinad S. Beidas PhD, Sindhu K. Srinivas MD MSCE, Lisa D. Levine MD MSCE

@RebeccaHammMD

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SLIDE 2

Background Too Complex Too Simple

We want implementations of evidence-based practices to work. How should we decide which components stay and which go?

@RebeccaHammMD

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SLIDE 3

Background

[Damschroder 2009]

How do we decide what components of an intervention need to be a part of the core?

@RebeccaHammMD

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SLIDE 4

Implementation Science & Health Disparities

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SLIDE 5

Background Pregnancy Baby Labor & Delivery

Labor induction = the stimulation of labor contractions during pregnancy before labor begins spontaneously, with the goal of achieving a vaginal delivery.

Frequency of Cervical Exams Artificial Rupture of Membranes Use of Oxytocin and Intrauterine Pressure Catheters Thresholds for Cesarean Delivery

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SLIDE 6

The US has the worst maternal death rate of developed countries.

@RebeccaHammMD

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SLIDE 7

[Martin 2015; Creanga 2014; Hirshberg 2017; Moaddab 2018; Yee 2017]

  • There are significant disparities between Black

and non-Black women in the United States in birth outcomes such as cesarean delivery rate, maternal morbidity, and neonatal morbidity

  • Non-Hispanic Black women in the US are

twice as likely to experience a fetal mortality and nearly 4 times more likely to die themselves in and around a pregnancy

  • Non-Hispanic Black women have higher

cesarean delivery rates than non-Hispanic White women even when accounting for sociodemographic and clinical differences

Background

@RebeccaHammMD

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SLIDE 8

Reduction in Neonatal Morbidity Among Black Women

70%

[Hamm 2019, Under Review]

Preliminary Data

Standardization of labor induction may be critical in reducing obstetric disparities. Retrospective cohort comparing:

  • (1) women enrolled in an RCT (Labor Protocol group)
  • (2) concurrent cohort managed at provider discretion (Observation Group)

5.5% 8.9% 3.6% 2.9% Non-Black Black

Neonatal Morbidity

Observation Group Labor Protocol Group

p=0.50 p=0.001

29.9% 34.6% 34.2% 25.7% Non-Black Black

Cesarean Rate

Observation Group Labor Protocol Group

p=0.45 p=0.02 Eliminated racial disparity; interaction p=0.04

35%

Reduction in Cesarean Rate Among Black Women @RebeccaHammMD

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SLIDE 9

Background

We are now planning a type I hybrid effectiveness-implementation trial to evaluate our standardized labor induction protocol

  • Slated for July 2020
MISOPROSTOL ONLY PROTOCOL 25mcg misoprostol placed (#1) Yes No Wait up to 3hrs more with regular assessment for window every 30 minutes. After 3 hours, is pt still contracting >3 times in 10 minutes during entire 3hrs? 25mcg miso placed (#2) Wait 3 hours Contracting >3 times in 10 minutes Yes No, pt had window during these 3hrs for 25mcg miso (#2) to be placed 25mcg miso placed (#2) This step can be repeated for up to a total of 6 misoprostols and for no more than 24 hours. After 6 misoprostols or 24 hrs
  • f misoprostol use, proceed to
pitocin After last misoprostol, wait 4 hrs before initiating pitocin
  • Pitocin can be initiated 4hrs after placement of last misoprostol
  • If patient is ≥4cm dilated and has intact membranes, perform amniotomy
  • If patient is in active labor (≥5cm dilated), proceed with active labor protocol.
  • If patient is not in active labor after 36 hours from the start of the induction, proceed with
cesarean delivery.
  • Exams should be performed:
  • Every 3hrs in latent labor if misoprostol being used
  • Every 2-4 hrs in latent labor if pitocin is being used
  • Every 1-2 hours in active labor
  • Notes should be written every 2-4hrs
Initiate pitocin per protocol CERVICAL FOLEY ONLY PROTOCOL Cervical foley placement Foley bulb placement:
  • Inflated with 60 cc
  • Placed on tension, with tension
checked q1hr
  • To be removed 12 hours after
placement or when falls out
  • If cervical foley cannot be placed at initial exam, a second higher level provider must attempt. If
still unable to place, exclude from study.
  • In order to call it a failed placement attempt, an attempt must be made with patient placed in
stirrups and under direct visualization.
  • Pitocin can be initiated once cervical foley has fallen out or after 12 hours in place
  • If patient is ≥4cm dilated and has intact membranes, perform amniotomy
  • If patient is in active labor (≥5cm dilated), proceed with active labor protocol.
  • If patient is not in active labor after 36 hours from the start of the induction, proceed with
cesarean delivery.
  • Exams should be performed:
  • Every 3hrs in latent labor if foley in place
  • Every 2-4 hrs in latent labor if pitocin is being used
  • Every 1-2 hours in active labor
  • Notes should be written every 2-4hrs
COMBINED MISO FOLEY PROTOCOL 25mcg misoprostol placed (#1) along with cervical foley Yes No 25mcg miso placed (#2) Yes No, pt had window during these 3hrs for 25mcg miso (#2) to be placed 25mcg miso placed (#2) This step can be repeated for up to a total of 6 misoprostols and for no more than 24
  • hours. After 6 misoprostols or 24 hrs of
misoprostol use, proceed to pitocin After last miso, wait 4 hrs before initiating pitocin
  • If cervical foley cannot be placed at initial exam, a second higher level provider must attempt. If still unable to
place, repeat exam in 1-2hrs from misoprostol placement to reattempt foley placement.
  • In order to call it a failed placement attempt, an attempt must be made with patient placed in stirrups and under
direct visualization.
  • Remove foley if still in place after 12hrs from placement. Can continue with misoprostol use after foley is removed
as long as it meets criteria noted above.
  • Pitocin can be initiated 4hrs after placement of last misoprostol, regardless of whether cervical foley still in situ
  • If patient is ≥4cm dilated and has intact membranes, perform amniotomy
  • If patient is in active labor (≥5cm dilated), proceed with active labor protocol.
  • If patient is not in active labor after 36 hours from the start of the induction, proceed with cesarean delivery.
  • Exams should be performed:
  • Every 3hrs in latent labor if misoprostol/foley being used
  • Every 2-4 hrs in latent labor if pitocin is being used
  • Every 1-2 hours in active labor
  • Notes should be written every 2-4hrs
Initiate pitocin per protocol Wait up to 3hrs more with regular assessment for window every 30 minutes After 3 hours, is pt still contracting >3 times in 10 minutes during entire 3hrs? Wait 3 hours. Contracting >3 times in 10 minutes? Foley bulb placement:
  • Inflated with 60 cc
  • Placed on tension, with tension
checked q1hr
  • To be removed 12 hours after
placement or when falls out

Too Complex

Our evidence-based pathway

Active labor protocol The FOR MOMI Trial Patient is in active labor (≥5cm dilation) Is patient ruptured? Yes No Is pt making ≥1cm cervical change? Perform amniotomy ≥1cm Cervical change? 2 hours Yes Adequate contractions? Continue current management and re-assess in 1-2 hrs Initiate/continue to increase pitocin to achieve adequate contractions ≥1cm Cervical change? Proceed with CD Continue with current management 2 hours ≥1cm Cervical change? Continue until completely dilated Continue with pitocin protocol Yes Initiate and/or continue pitocin protocol Continue with current management (expectant or pitocin) Yes No Re-examine no more than 2hrs after amniotomy Is IUPC in place No Place IUPC and re-assess in 1-2hrs No Yes Yes No 2 hours Yes No 1-2 hours No
  • If multiparous patients are not delivered in 12 hrs after the start of active labor, proceed with cesarean
  • If nulliparous patients are not delivered in 16 hrs after the start of active labor, proceed with cesarean
  • Routine second stage management should continued
  • Exams should be performed:
  • every 1-2hrs in active phase
  • every 1hr in 2nd stage
  • Notes should be written:
  • every 2hrs in active phase
  • every 1hr in 2nd stage

Page 1

COMBINED FOLEY & PITOCIN PROTOCOL Cervical foley placement & initiation of pitocin per protocol
  • If cervical foley cannot be placed at initial exam, a second higher level provider must attempt. If
still unable to place, begin pitocin without cervical foley and repeat placement attempt every 1- 2hrs
  • In order to call it a failed placement attempt, an attempt must be made with patient placed in
stirrups and under direct visualization.
  • Remove foley if still in place 12 hrs after placement. Continue pitocin at this time.
  • If patient is ≥4cm dilated and has intact membranes, perform amniotomy
  • If patient is in active labor (≥5cm dilated), proceed with active labor protocol.
  • If patient is not in active labor after 36 hours from the start of the induction, proceed with
cesarean delivery.
  • Exams should be performed:
  • Every 3hrs in latent labor if foley in place
  • Every 2-4 hrs in latent labor if pitocin is being used
  • Every 1-2 hours in active labor
  • Notes should be written every 2-4hrs
Foley bulb placement:
  • Inflated with 60 cc
  • Placed on tension, with tension
checked q1hr
  • To be removed 12 hours after
placement or when falls out

Page 2 Page 3 Page 4 Page 5

@RebeccaHammMD

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SLIDE 10

Objective

to determine which components of our effective labor induction protocol were essential to improving three important obstetric outcomes:

  • cesarean delivery rate
  • maternal morbidity
  • neonatal morbidity

determine core protocol components streamline our labor induction protocol test that protocol in a type I hybrid effectiveness- implementation trial (remove components that do not improve effectiveness -> a novel strategy for a successful implementation) Future Goal: July 2020

@RebeccaHammMD

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SLIDE 11

Study Design

Hospital of the University of Pennsylvania

  • secondary analysis of a randomized clinical trial
  • compared time to delivery among four different induction methods:

Arm #1: Arm #2: Arm #3: Arm #4: misoprostol alone cervical Foley alone misoprostol/ cervical Foley concurrently cervical Foley/

  • xytocin concurrently

May 2013 to June 2015

  • approved by the institutional review board at the University of Pennsylvania @RebeccaHammMD
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SLIDE 12

Inclusion/Exclusion

Inclusion:

  • ≥18 years of age
  • Term (>37 weeks gestation) in cephalic presentation
  • Amniotic membranes intact
  • Undergoing labor induction

Exclusion:

  • Prior cesarean
  • Multiple gestation (twins, triplets)
  • Contraindication to vaginal delivery
  • Major fetal anomaly
  • Non-English speaking
  • Maternal condition requiring special management in labor such as

HIV or eclampsia

@RebeccaHammMD

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SLIDE 13

The Evidence Based Practice: The Standardized Labor Protocol

  • ALL women enrolled in this RCT were supposed to be managed with the standardized labor

induction protocol as part of the trial

  • But that doesn’t mean that providers were compliant with every aspect of this complicated

protocol for every patient.

@RebeccaHammMD

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SLIDE 14 MISOPROSTOL ONLY PROTOCOL 25mcg misoprostol placed (#1) Yes No Wait up to 3hrs more with regular assessment for window every 30 minutes. After 3 hours, is pt still contracting >3 times in 10 minutes during entire 3hrs? 25mcg miso placed (#2) Wait 3 hours Contracting >3 times in 10 minutes Yes No, pt had window during these 3hrs for 25mcg miso (#2) to be placed 25mcg miso placed (#2) This step can be repeated for up to a total of 6 misoprostols and for no more than 24 hours. After 6 misoprostols or 24 hrs
  • f misoprostol use, proceed to
pitocin After last misoprostol, wait 4 hrs before initiating pitocin
  • Pitocin can be initiated 4hrs after placement of last misoprostol
  • If patient is ≥4cm dilated and has intact membranes, perform amniotomy
  • If patient is in active labor (≥5cm dilated), proceed with active labor protocol.
  • If patient is not in active labor after 36 hours from the start of the induction, proceed with
cesarean delivery.
  • Exams should be performed:
  • Every 3hrs in latent labor if misoprostol being used
  • Every 2-4 hrs in latent labor if pitocin is being used
  • Every 1-2 hours in active labor
  • Notes should be written every 2-4hrs
Initiate pitocin per protocol CERVICAL FOLEY ONLY PROTOCOL Cervical foley placement Foley bulb placement:
  • Inflated with 60 cc
  • Placed on tension, with tension
checked q1hr
  • To be removed 12 hours after
placement or when falls out
  • If cervical foley cannot be placed at initial exam, a second higher level provider must attempt. If
still unable to place, exclude from study.
  • In order to call it a failed placement attempt, an attempt must be made with patient placed in
stirrups and under direct visualization.
  • Pitocin can be initiated once cervical foley has fallen out or after 12 hours in place
  • If patient is ≥4cm dilated and has intact membranes, perform amniotomy
  • If patient is in active labor (≥5cm dilated), proceed with active labor protocol.
  • If patient is not in active labor after 36 hours from the start of the induction, proceed with
cesarean delivery.
  • Exams should be performed:
  • Every 3hrs in latent labor if foley in place
  • Every 2-4 hrs in latent labor if pitocin is being used
  • Every 1-2 hours in active labor
  • Notes should be written every 2-4hrs
COMBINED MISO FOLEY PROTOCOL 25mcg misoprostol placed (#1) along with cervical foley Yes No 25mcg miso placed (#2) Yes No, pt had window during these 3hrs for 25mcg miso (#2) to be placed 25mcg miso placed (#2) This step can be repeated for up to a total of 6 misoprostols and for no more than 24
  • hours. After 6 misoprostols or 24 hrs of
misoprostol use, proceed to pitocin After last miso, wait 4 hrs before initiating pitocin
  • If cervical foley cannot be placed at initial exam, a second higher level provider must attempt. If still unable to
place, repeat exam in 1-2hrs from misoprostol placement to reattempt foley placement.
  • In order to call it a failed placement attempt, an attempt must be made with patient placed in stirrups and under
direct visualization.
  • Remove foley if still in place after 12hrs from placement. Can continue with misoprostol use after foley is removed
as long as it meets criteria noted above.
  • Pitocin can be initiated 4hrs after placement of last misoprostol, regardless of whether cervical foley still in situ
  • If patient is ≥4cm dilated and has intact membranes, perform amniotomy
  • If patient is in active labor (≥5cm dilated), proceed with active labor protocol.
  • If patient is not in active labor after 36 hours from the start of the induction, proceed with cesarean delivery.
  • Exams should be performed:
  • Every 3hrs in latent labor if misoprostol/foley being used
  • Every 2-4 hrs in latent labor if pitocin is being used
  • Every 1-2 hours in active labor
  • Notes should be written every 2-4hrs
Initiate pitocin per protocol Wait up to 3hrs more with regular assessment for window every 30 minutes After 3 hours, is pt still contracting >3 times in 10 minutes during entire 3hrs? Wait 3 hours. Contracting >3 times in 10 minutes? Foley bulb placement:
  • Inflated with 60 cc
  • Placed on tension, with tension
checked q1hr
  • To be removed 12 hours after
placement or when falls out Active labor protocol The FOR MOMI Trial Patient is in active labor (≥5cm dilation) Is patient ruptured? Yes No Is pt making ≥1cm cervical change? Perform amniotomy ≥1cm Cervical change? 2 hours Yes Adequate contractions? Continue current management and re-assess in 1-2 hrs Initiate/continue to increase pitocin to achieve adequate contractions ≥1cm Cervical change? Proceed with CD Continue with current management 2 hours ≥1cm Cervical change? Continue until completely dilated Continue with pitocin protocol Yes Initiate and/or continue pitocin protocol Continue with current management (expectant or pitocin) Yes No Re-examine no more than 2hrs after amniotomy Is IUPC in place No Place IUPC and re-assess in 1-2hrs No Yes Yes No 2 hours Yes No 1-2 hours No
  • If multiparous patients are not delivered in 12 hrs after the start of active labor, proceed with cesarean
  • If nulliparous patients are not delivered in 16 hrs after the start of active labor, proceed with cesarean
  • Routine second stage management should continued
  • Exams should be performed:
  • every 1-2hrs in active phase
  • every 1hr in 2nd stage
  • Notes should be written:
  • every 2hrs in active phase
  • every 1hr in 2nd stage
COMBINED FOLEY & PITOCIN PROTOCOL Cervical foley placement & initiation of pitocin per protocol
  • If cervical foley cannot be placed at initial exam, a second higher level provider must attempt. If
still unable to place, begin pitocin without cervical foley and repeat placement attempt every 1- 2hrs
  • In order to call it a failed placement attempt, an attempt must be made with patient placed in
stirrups and under direct visualization.
  • Remove foley if still in place 12 hrs after placement. Continue pitocin at this time.
  • If patient is ≥4cm dilated and has intact membranes, perform amniotomy
  • If patient is in active labor (≥5cm dilated), proceed with active labor protocol.
  • If patient is not in active labor after 36 hours from the start of the induction, proceed with
cesarean delivery.
  • Exams should be performed:
  • Every 3hrs in latent labor if foley in place
  • Every 2-4 hrs in latent labor if pitocin is being used
  • Every 1-2 hours in active labor
  • Notes should be written every 2-4hrs
Foley bulb placement:
  • Inflated with 60 cc
  • Placed on tension, with tension
checked q1hr
  • To be removed 12 hours after
placement or when falls out

7

Fidelity Measures Study Design

Our evidence-based practice

@RebeccaHammMD

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SLIDE 15

Standardized Labor Induction Protocol Fidelity Measures Measure Protocol Recommendation Compliance Determination Theme #1: Do not continue futile procedures. #1 If a foley balloon is utilized, it is to be removed 12 hours after placement or when falls out. If a foley balloon was utilized, did it fall out/was it removed by 12.5 hours after placement? #2 If misoprostol is utilized, it should not be continued beyond 6 doses or 24 hours of use. If misoprostol was used, was it used for less than 24 hours and less than or equal to 6 doses? Theme #2: Frequent exams will allow for more frequent intervention when no change is made. #3 Exams should be performed every 2-4 hours in latent labor. Were all exams in latent labor performed less than

  • r equal to 4.5 hours apart?

#4 Exams should be performed every 1-2hrs in active phase . Were all exams in active labor performed less than

  • r equal to 2.5 hours apart?

Theme #3: Intervention when cervical change is not made. #5 If patient is ≥4cm dilated and has intact membranes, perform amniotomy. If the patient reached 4cm, was the patient already ruptured or amniotomy performed at that exam? #6 If patient has same exam 2 hours apart in active labor, and is already ruptured, oxytocin should be started. If active labor was reached and the patient was already ruptured with 2 exams at the same dilation 2 hours apart, was oxytocin started/running? #7 If patient has same exam 2 hours apart in active labor, and is already on oxytocin/ruptured, place intrauterine pressure catheter. If active labor was reached and the patient was already ruptured and on oxytocin with 2 exams at the same dilation 2 hours apart, was an intrauterine pressure catheter placed?

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SLIDE 16

The Stages of Labor

@RebeccaHammMD

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SLIDE 17

Standardized Labor Induction Protocol Fidelity Measures Measure Protocol Recommendation Compliance Determination #3 Exams should be performed every 2-4 hours in latent labor. Were all exams in latent labor performed less than

  • r equal to 4.5 hours apart?

@RebeccaHammMD

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SLIDE 18

Fidelity Measure #3: Exams should be performed every 2-4 hours in latent labor.

  • Calculate time between all exams in latent labor
  • If all <4.5 hours, considered “yes, compliant”

for this fidelity measure; coded as “1”

  • If any ≥4.5 hours, considered “non-compliant”

for this fidelity measure; coded as “0”

@RebeccaHammMD

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SLIDE 19

Standardized Labor Induction Protocol Fidelity Measures Measure Protocol Recommendation Compliance Determination Theme #1: Do not continue futile procedures. #1 If a foley balloon is utilized, it is to be removed 12 hours after placement or when falls out. If a foley balloon was utilized, did it fall out/was it removed by 12.5 hours after placement? #2 If misoprostol is utilized, it should not be continued beyond 6 doses or 24 hours of use. If misoprostol was used, was it used for less than 24 hours and less than or equal to 6 doses? Theme #2: Frequent exams will allow for more frequent intervention when no change is made. #3 Exams should be performed every 2-4 hours in latent labor. Were all exams in latent labor performed less than

  • r equal to 4.5 hours apart?

#4 Exams should be performed every 1-2hrs in active phase . Were all exams in active labor performed less than

  • r equal to 2.5 hours apart?

Theme #3: Intervention when cervical change is not made. #5 If patient is ≥4cm dilated and has intact membranes, perform amniotomy. If the patient reached 4cm, was the patient already ruptured or amniotomy performed at that exam? #6 If patient has same exam 2 hours apart in active labor, and is already ruptured, oxytocin should be started. If active labor was reached and the patient was already ruptured with 2 exams at the same dilation 2 hours apart, was oxytocin started/running? #7 If patient has same exam 2 hours apart in active labor, and is already on oxytocin/ruptured, place intrauterine pressure catheter. If active labor was reached and the patient was already ruptured and on oxytocin with 2 exams at the same dilation 2 hours apart, was an intrauterine pressure catheter placed?

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SLIDE 20

Outcomes: Effectiveness

Primary Outcomes Maternal morbidity Cesarean rate Neonatal morbidity

  • Composite maternal morbidity: blood transfusion, endometritis, wound

separation/infection, venous thromboembolism, hysterectomy, intensive care unit admission, or death

  • Composite neonatal morbidity: neonatal resuscitation requiring supplemental oxygen
  • utside of the delivery room or culture proven/presumed neonatal sepsis

@RebeccaHammMD

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SLIDE 21

Cesarean rate Maternal morbidity Neonatal morbidity

Bivariate Analyses

If a foley balloon was utilized, did it fall out/was it removed by 12.5 hours after placement? If misoprostol was used, was it used for less than 24 hours and less than or equal to 6 doses? Were all exams in latent labor performed less than

  • r equal to 4.5 hours apart?

Were all exams in active labor performed less than

  • r equal to 2.5 hours apart?

If the patient reached 4cm, was the patient already ruptured or amniotomy performed at that exam? If active labor was reached and the patient was already ruptured with 2 exams at the same dilation 2 hours apart, was oxytocin started/running? If active labor was reached and the patient was already ruptured and on oxytocin with 2 exams at the same dilation 2 hours apart, was an intrauterine pressure catheter placed?

Fidelity Measures Effectiveness Outcomes

@RebeccaHammMD

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SLIDE 22

Effectiveness outcome

Multivariable Analyses

was used to assess for independent predictors of each outcome while controlling for key demographic and clinical factors that impact cesarean and morbidity.

Race BMI Parity

@RebeccaHammMD

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SLIDE 23

Results

@RebeccaHammMD

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SLIDE 24

Demographic Ma Mate tern rnal Age* 27 [22-32] Rac ace Black ack/Afri frican Ameri rican Cau aucasi sian Asian Other/ r/Unknown 381 (77.6) 76 (15.5) 11 (2.2) 23 (4.7) BMI MI at delivery ry <2 <25.0 .0 (Norm rmal al weigh ght) 25.0-29.9 .9 (Overw rweight) t) 30.0-34.9 .9 (Ob Obese se Class ass 1) 35.0-39.9 .9 (Obese se Class ass 2) ≥40.0 (Obese Class 3) 29 (6.3) 123 (26.9) 110 (24.0) 105 (22.9) 91 (20.0) Insu suran ance Pri rivate Public/Uninsu sured 165 (33.6) 326 (66.4) Nulliparous s 290 (59.1)

Results

Ge Gestati tional ag age at inducti tion 39 [38-40] Diab abetes Ge Gestati tional al diab abetes Pre-gestati tional al 33 (6.7) 11 (2.2) Chronic hyp ypert rtensi sion 40 (8.1) Pre regnancy Related Hyp ypert rtensi sion GH GHTN/Mild PEC Severe/Superi rimpose sed PEC 114 (23.2) 50 (10.2) Indicati tion for r inducti tion Later r te term rm/post-term rm Ma Matern rnal al Fe Fetal Electi tive/Other 64 (13.0) 148 (30.1) 225 (45.8) 54 (11.0) Bish shop score at inducti tion 3 [2-4] Cervical dilati tion at induction 1 [1-1.5]

n=491

slide-25
SLIDE 25

Results

Bivariate Analysis

If a foley balloon was utilized, did it fall out/was it removed by 12.5 hours after placement? If misoprostol was used, was it used for less than 24 hours and less than or equal to 6 doses? Were all exams in latent labor performed less than

  • r equal to 4.5 hours apart?

Were all exams in active labor performed less than

  • r equal to 2.5 hours apart?

If the patient reached 4cm, was the patient already ruptured or amniotomy performed at that exam? If active labor was reached and the patient was already ruptured with 2 exams at the same dilation 2 hours apart, was oxytocin started/running? If active labor was reached and the patient was already ruptured and on oxytocin with 2 exams at the same dilation 2 hours apart, was an intrauterine pressure catheter placed?

Cesarean rate

Fidelity Measure N (%) Cesarean Delivery p value #1 0.13 Yes, Compliant 351 (96.7%) 103 (29.3%) No, Noncompliant 12 (3.3%) 6 (50.0%) #2 <0.001 Yes, Compliant 197 (82.8%) 40 (20.3%) No, Noncompliant 41 (17.2%) 20 (48.8%) #3 0.001 Yes, Compliant 243 (49.5%) 51 (21.0%) No, Noncompliant 248 (50.5%) 85 (34.3%) #4 <0.001 Yes, Compliant 305 (67.9%) 45 (14.8%) No, Noncompliant 144 (32.1%) 49 (34.0%) #5 0.35 Yes, Compliant 357 (74.2%) 91 (25.5%) No, Noncompliant 124 (25.8%) 37 (29.8%) #6 1.00 Yes, Compliant 356 (98.1%) 88 (24.7%) No, Noncompliant 7 (1.9%) 1 (14.3%) #7 0.002 Yes, Compliant 411 (91.7%) 79 (19.2%) No, Noncompliant 37 (8.3%) 15 (40.5%)

slide-26
SLIDE 26

Results

Bivariate Analysis

If a foley balloon was utilized, did it fall out/was it removed by 12.5 hours after placement? If misoprostol was used, was it used for less than 24 hours and less than or equal to 6 doses? Were all exams in latent labor performed less than

  • r equal to 4.5 hours apart?

Were all exams in active labor performed less than

  • r equal to 2.5 hours apart?

If the patient reached 4cm, was the patient already ruptured or amniotomy performed at that exam? If active labor was reached and the patient was already ruptured with 2 exams at the same dilation 2 hours apart, was oxytocin started/running? If active labor was reached and the patient was already ruptured and on oxytocin with 2 exams at the same dilation 2 hours apart, was an intrauterine pressure catheter placed?

Maternal morbidity

Fidelity Measure N (%) Cesarean Delivery p value #1 0.07 Yes, Compliant 351 (96.7%) 27 (7.7%) No, Noncompliant 12 (3.3%) 3 (25.0%) #2 0.005 Yes, Compliant 197 (82.8%) 7 (3.6%) No, Noncompliant 41 (17.2%) 6 (14.6%) #3 0.53 Yes, Compliant 243 (49.5%) 16 (6.6%) No, Noncompliant 248 (50.5%) 20 (8.1%) #4 0.58 Yes, Compliant 305 (67.9%) 19 (6.2%) No, Noncompliant 144 (32.1%) 11 (7.6%) #5 0.62 Yes, Compliant 357 (74.2%) 24 (6.7%) No, Noncompliant 124 (25.8%) 10 (8.1%) #6 1.00 Yes, Compliant 356 (98.1%) 27 (7.6%) No, Noncompliant 7 (1.9%) 0 (0) #7 0.30 Yes, Compliant 411 (91.7%) 26 (6.3%) No, Noncompliant 37 (8.3%) 4 (10.8%)

slide-27
SLIDE 27

Results

Bivariate Analysis

If a foley balloon was utilized, did it fall out/was it removed by 12.5 hours after placement? If misoprostol was used, was it used for less than 24 hours and less than or equal to 6 doses? Were all exams in latent labor performed less than

  • r equal to 4.5 hours apart?

Were all exams in active labor performed less than

  • r equal to 2.5 hours apart?

If the patient reached 4cm, was the patient already ruptured or amniotomy performed at that exam? If active labor was reached and the patient was already ruptured with 2 exams at the same dilation 2 hours apart, was oxytocin started/running? If active labor was reached and the patient was already ruptured and on oxytocin with 2 exams at the same dilation 2 hours apart, was an intrauterine pressure catheter placed?

Neonatal morbidity

Fidelity Measure N (%) Cesarean Delivery p value #1 0.64 Yes, Compliant 351 (96.7%) 13 (3.7%) No, Noncompliant 12 (3.3%) 0 (0) #2 0.28 Yes, Compliant 197 (82.8%) 4 (2.0%) No, Noncompliant 41 (17.2%) 2 (4.9%) #3 0.03 Yes, Compliant 243 (49.5%) 3 (1.2%) No, Noncompliant 248 (50.5%) 12 (4.8%) #4 0.03 Yes, Compliant 305 (67.9%) 5 (1.6%) No, Noncompliant 144 (32.1%) 8 (5.6%) #5 1.00 Yes, Compliant 357 (74.2%) 11 (3.1%) No, Noncompliant 124 (25.8%) 3 (2.4%) #6 1.00 Yes, Compliant 356 (98.1%) 13 (3.7%) No, Noncompliant 7 (1.9%) 0 (0) #7 0.29 Yes, Compliant 411 (91.7%) 11 (2.7%) No, Noncompliant 37 (8.3%) 2 (5.4%)

slide-28
SLIDE 28

Results

Multivariable Analysis

Cesarean rate Maternal morbidity Neonatal morbidity

Were all exams in active labor performed less than or equal to 2.5 hours apart? If a foley balloon was utilized, did it fall out/was it removed by 12.5 hours after placement? Were all exams in latent labor performed less than

  • r equal to 4.5 hours apart?

Were all exams in active labor performed less than or equal to 2.5 hours apart?

Theme #2: frequent exams will allow for more frequent intervention when no cervical change is made Theme #2: frequent exams will allow for more frequent intervention when no cervical change is made Theme #1: do not continue futile procedures

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SLIDE 29

Conclusions

This study examined individual components of a standardized labor induction protocol and their association with critical obstetric effectiveness

  • utcomes

In finding three of seven fidelity measures to be independently associated with cesarean delivery, maternal morbidity, or neonatal morbidity, we have the potential to streamline our labor induction protocol to focus on these components

@RebeccaHammMD

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SLIDE 30

Conclusions

Those components found to be important mainly fell under the theme: “frequent exams in labor will allow for more frequent intervention when no change is made”

Frequent exams can diagnose issues with labor progress Intervene more quickly Prevent lengthy and failed inductions Cesarean delivery Maternal morbidity Neonatal morbidity

@RebeccaHammMD

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SLIDE 31

Limitations

  • Less concrete protocol components cannot be evaluated
  • Some components were adhered to “too well”
  • Difficult to see an association with effectiveness
  • Should we just incorporate these components anyway?
  • Maternal and neonatal morbidity are rare outcomes
  • The parent RCT for this analysis was performed at one urban, academic site

@RebeccaHammMD

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SLIDE 32

Implications for D&I Research

This study is unique in its overarching goal: to utilize data on fidelity to individual intervention components and their association with effectiveness as a means to select core protocol components prior to large-scale implementation. Streamlining a multi-component intervention in an evidence-based fashion could present a novel strategy to improve implementation acceptability, adoption, and penetration.

Pregnancy Baby Labor & Delivery Pregnancy Baby Labor & Delivery

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SLIDE 33

University of Pennsylvania Department of OBGYN & Division of Maternal Fetal Medicine Maternal Child Health Research Center Penn Implementation Science Center Center for Clinical Epidemiology and Biostatistics

Thank You.

@RebeccaHammMD

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SLIDE 34

Resources

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