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. Srinivas MD MSCE, Lisa D. Levine MD MSCE Maternal & Child Health Research Center University of Pennsylvania 12th Annual Conference on the Science of Dissemination and Implementation D e c e m b e r 6 , 2 0 1 9 @RebeccaHammMD
Background We want implementations of evidence-based practices to work. Too Complex Too Simple How should we decide which components stay and which go? @RebeccaHammMD
Background How do we decide what components of an intervention need to be a part of the core? [Damschroder 2009] @RebeccaHammMD
Implementation Science & Health Disparities
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 Use of Oxytocin and Artificial Rupture of Exams Intrauterine Pressure Membranes Catheters Thresholds for Cesarean Delivery
The US has the worst maternal death rate of developed countries. @RebeccaHammMD
Background • 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 [Martin 2015; Creanga 2014; Hirshberg 2017; Moaddab 2018; Yee 2017] @RebeccaHammMD
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) • Neonatal Morbidity Cesarean Rate p=0.02 p=0.45 p=0.001 8.9% 34.6% 34.2% 29.9% 25.7% p=0.50 5.5% Reduction in 70% 35% Reduction in Neonatal Cesarean Rate Morbidity 3.6% Among Black Among Black Women 2.9% Women Non-Black Non-Black Black Black Observation Group Observation Group Labor Protocol Group Labor Protocol Group Eliminated racial disparity; interaction p=0.04 [Hamm 2019, Under Review] @RebeccaHammMD
Background We are now planning a type I hybrid effectiveness-implementation trial to evaluate our standardized labor induction protocol Slated for July 2020 • Our evidence-based pathway CERVICAL FOLEY ONLY PROTOCOL MISOPROSTOL ONLY PROTOCOL COMBINED MISO FOLEY PROTOCOL 25mcg misoprostol Cervical foley placed (#1) placement 25mcg misoprostol placed (#1) along with cervical foley Wait 3 hours Contracting >3 times in 10 minutes Foley bulb placement: Wait 3 hours. • Inflated with 60 cc Contracting >3 times in 10 minutes? • Placed on tension, with tension Foley bulb placement: checked q1hr • Yes No • Inflated with 60 cc To be removed 12 hours after placement or when falls out Yes No • Placed on tension, with tension Wait up to 3hrs more with regular 25mcg miso checked q1hr assessment for window every 30 minutes. placed (#2) • To be removed 12 hours after Wait up to 3hrs more with regular 25mcg miso After 3 hours, is pt still contracting >3 times assessment for window every 30 minutes placed (#2) in 10 minutes during entire 3hrs? placement or when falls out After 3 hours, is pt still contracting >3 times in 10 minutes during entire 3hrs? Yes No, pt had window during these 3hrs for Yes No, pt had window 25mcg miso (#2) to be during these 3hrs for 25mcg miso (#2) to be placed Initiate pitocin placed Initiate pitocin per protocol per protocol 25mcg miso 25mcg miso placed (#2) placed (#2) After last misoprostol, This step can be repeated for up After last miso, wait 4 This step can be repeated for up to a total of wait 4 hrs before to a total of 6 misoprostols and hrs before initiating 6 misoprostols and for no more than 24 initiating pitocin for no more than 24 hours. pitocin hours. After 6 misoprostols or 24 hrs of After 6 misoprostols or 24 hrs • misoprostol use, proceed to pitocin If cervical foley cannot be placed at initial exam, a second higher level provider must attempt. If of misoprostol use, proceed to pitocin still unable to place, exclude from study. • • If cervical foley cannot be placed at initial exam, a second higher level provider must attempt. If still unable to In order to call it a failed placement attempt, an attempt must be made with patient placed in place, repeat exam in 1-2hrs from misoprostol placement to reattempt foley placement. stirrups and under direct visualization. • In order to call it a failed placement attempt, an attempt must be made with patient placed in stirrups and under • Pitocin can be initiated once cervical foley has fallen out or after 12 hours in place direct visualization. • • If patient is ≥4cm dilated and has intact membranes, perform amniotomy • Pitocin can be initiated 4hrs after placement of last misoprostol Remove foley if still in place after 12hrs from placement. Can continue with misoprostol use after foley is removed • If patient is ≥4cm dilated and has intact membranes, perform amniotomy • If patient is in active labor (≥5cm dilated), proceed with active labor protocol. as long as it meets criteria noted above. • If patient is in active labor (≥5cm dilated), proceed with active labor protocol. • Pitocin can be initiated 4hrs after placement of last misoprostol, regardless of whether cervical foley still in situ • • If patient is not in active labor after 36 hours from the start of the induction, proceed with If patient is not in active labor after 36 hours from the start of the induction, proceed with • If patient is ≥4cm dilated and has intact membranes, perform amniotomy cesarean delivery. cesarean delivery. • If patient is in active labor (≥5cm dilated), proceed with active labor protocol. • Exams should be performed: • • Exams should be performed: If patient is not in active labor after 36 hours from the start of the induction, proceed with cesarean delivery. o Every 3hrs in latent labor if misoprostol being used • o Every 3hrs in latent labor if foley in place Exams should be performed: o Every 2-4 hrs in latent labor if pitocin is being used o Every 3hrs in latent labor if misoprostol/foley being used o Every 1-2 hours in active labor o Every 2-4 hrs in latent labor if pitocin is being used o Every 2-4 hrs in latent labor if pitocin is being used • Notes should be written every 2-4hrs o o Every 1-2 hours in active labor Every 1-2 hours in active labor • • Notes should be written every 2-4hrs Notes should be written every 2-4hrs Page 2 Page 1 Page 3 Active labor protocol Patient is in active labor The FOR MOMI Trial (≥5cm dilation) Yes Is patient ruptured? No COMBINED FOLEY & PITOCIN PROTOCOL Re-examine no more than 2hrs after amniotomy Is pt making ≥1cm Perform amniotomy Cervical foley placement & cervical change? initiation of pitocin per No Yes protocol Place IUPC Continue with current Initiate and/or continue Too Complex and re-assess pitocin protocol management in 1-2hrs No (expectant or pitocin) 2 Is IUPC in place hours No Foley bulb placement: • Inflated with 60 cc Yes ≥1cm Cervical change? • Placed on tension, with tension Adequate checked q1hr Yes contractions? • To be removed 12 hours after placement or when falls out Continue with current Yes management No Continue current management Continue 2 and re-assess in until hours Initiate/continue to 1-2 hrs completely increase pitocin to dilated ≥1cm Cervical change? achieve adequate No contractions 2 1-2 • Yes If cervical foley cannot be placed at initial exam, a second higher level provider must attempt. If hours hours still unable to place, begin pitocin without cervical foley and repeat placement attempt every 1- ≥1cm Cervical change? 2hrs • In order to call it a failed placement attempt, an attempt must be made with patient placed in Yes No 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 memb ranes, perform amniotomy Continue with pitocin protocol Proceed with CD • 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 • If multiparous patients are not delivered in 12 hrs after the start of active labor, proceed with cesarean cesarean delivery. • If nulliparous patients are not delivered in 16 hrs after the start of active labor, proceed with cesarean • Exams should be performed: • Routine second stage management should continued o • Exams should be performed: Every 3hrs in latent labor if foley in place o every 1-2hrs in active phase o Every 2-4 hrs in latent labor if pitocin is being used o every 1hr in 2 nd stage o Every 1-2 hours in active labor • Notes should be written: • Notes should be written every 2-4hrs o every 2hrs in active phase o every 1hr in 2 nd stage @RebeccaHammMD Page 4 Page 5
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