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S The New Pitocin Protocol Ben Klug, PGY-3

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Page 1: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

S

The New Pitocin

ProtocolBen Klug, PGY-3

Page 2: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Pitocin

S Oxytocin is a polypeptide hormone produced in the hypothalamus and secreted from the posterior lobe of the pituitary gland in a pulsatile fashion. It is identical to its synthetic analog, Pitocin.

S ½ life 3-6 minutes

S HCA ½ life 10-12 minutes

S HCA= High Alert Medication= lowest possible dose that is effective

S Historically, synthetic oxytocin was diluted by placing 10 units in 1000 mL of an isotonic solution

S Today use 60 units in 1000 mL crystalloid to allow the infusion pump setting to match the dose administered

Page 3: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Oxytocin

S Contractions

S Let-down

S Social behavior

S Fear

S Trust

S Wound healing

S Autism

S Empathy

S Romantic attraction

Page 4: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Pitocin

S Endogenous levels= 2-4 maternal, 3 fetal= 5-7 total

S Exogenous oxytocin able to produce contractions at approximately 20 weeks of gestation, with increasing responsiveness with advancing gestational age. There is little change in myometrial sensitivity to oxytocin from 34 weeks to term.

S Once spontaneous labor begins, the uterine sensitivity to oxytocin increases rapidly due to increase in myometrial oxytocin binding sites.

S Progress during spontaneous labor is not related to increasing oxytocin concentration, uterine contractions are not associated with changes in plasma oxytocin concentration, and hypocontractile labor does not appear to be the result of a deficit of oxytocin.

S Inverse relationship of duration and number of available receptors (may equal abnormal ctx patterns).

Page 5: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

High or Low

S Protocols differ as to initial dose (0.5 to 6 mU/min), time period between dose increments (10 to 60 minutes), and maximum dose (16 to 64 mU/minute), but success rates for varying protocols are strikingly similar.

S A literature review of randomized trials of high- versus low-dose oxytocin regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission to vaginal delivery, but did not decrease the incidence of cesarean delivery compared with low-dose therapy.

S High-dose regimens are associated with a higher rate of tachysystole than low-dose regimens and, in some studies, this has resulted in a higher rate of cesarean delivery for nonreassuring fetal heart rate tracings, but no significant difference in neonatal outcomes.

Page 6: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission
Page 7: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Timing

S Steady State- dynamic equilibrium

S 50% of steady state in 1 half life

75% in 2 half lives

87.5 % in 3 half lives

90% in 3.3

94-97% in 4-5 half lives. (clinical steady state)

Page 8: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Goal

S Pit increased until there is normal progression of labor, or strong contractions occurring at two- to three-minute intervals, or uterine activity reaches 200 to 250 Montevideo units.

S There is no benefit to increasing the dose after one of these endpoints has been achieved.

S To continue or not continue? Conflicting evidence.

S Discontinuation prolongs labor

S No benefit of continuing once in active labor.

S No consensus reached/recommended.

Page 9: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Perinatal Safety InitiativeJan. 2014

S Goal: Healthy Mom and Healthy Baby

S Understand guiding principles and standard approaches

for the safe delivery of oxytocin.

S Understand the historical perspective of the development

of the recommended guidelines and checklist for

oxytocin.

S Recognize new data supporting the standard oxytocin

practices and neonatal outcomes.

Page 10: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission
Page 11: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Evidence Based Medicine

S Trumps “In my experience…”

S Trumps “I feel like it today.”

S Trumps “I’m the doctor and I say so.”

S Mandates chain of command for alternative approaches

to care.

Page 12: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Tachysystole

Page 13: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Tachysystole

S By ACOG definition: greater than 5 contractions in a 10

minute period, average over 30 minute period.

S HCA definition: greater than 5 contractions in a 10 min

period, averaged over 20 minutes.

Page 14: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Why It Matters

S More time between contractions = more time to maximally perfuse fetus

S SpO2 of fetus lowest at 92 sec after peak of contraction and takes approx 90 sec to return to normal. Therefore, contractions every 2 min or more = incomplete perfusion

S Progressive desaturation occurs with approximately 5 minutes of tachysystole

S According to Bakker study: significantly more acidemia when tachysystole present in labor.

Page 15: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission
Page 16: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Oxytocin AuditApril- September, 2013

S Each HCA facility audited designated number of consecutive

charts of women whose labors were induced with oxytocin

S Number determined to represent a statistically valid sample

size for each facility.

S Audits conducted by local, AWHONN and FHRM instructors.

S N= 14,398 charts

Page 17: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Compliance Parameters

S Monitoring prior to starting Pitocin

S Pelvic adequacy

S Pre-Use checklist

S In-Use checklist

S FHR tracing (95% of the time)

S Ctx tracing (95% of the time)

Page 18: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Outcome Parameters

S Route of delivery (SVD, OVD, or C/S)

S NICU admission

S 1 minute apgar <7

S 5 minute apgar <7

Page 19: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Results

Page 20: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission
Page 21: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission
Page 22: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission
Page 23: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Results

Page 24: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Importance of Results

S System compliance is suboptimal

S Non-compliance involves:

S Behavior/attitude/leadership

S Work ethic/patient load

S Knowledge deficit

S Compliance yields significantly improved outcomes

Page 25: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Importance of Results

S First study to document improved newborn outcomes

with the use (and proper interpretation/management) with

EFM.

S Avoids past errors of looking at diagnostic tool and

expecting it to yield therapeutic results.

S Establishes clear definition of abnormal.

S Pending peer review/publication, HCA protocol is the only

evidence-based approach to oxytocin management.

Page 26: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Where We Are Now

S Self Audit- 12/13

S Plan for improvement- 1/15/14

S Implement plan- Spring 2014

S Repeat 3 month audit- 4/14/14

S Goal= 95% compliance with protocol and checklists

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Before We Begin…

S Pre-checklist completed

S Signed order on chart

S Current H&P

S Prenatal Record

S Indication

S Pelvis adequate per Dr.

S Estimated fetal weight

S Gestational age

S LDR consent signed

S Physician available

S Cvx assessed & documented

S Fetal presentation

S Fetal assessment

S 30 min FHT, Reactive

S 8/8 BPP in 4 hours

S No lates

S No greater than 2 variables>60 sec and decreasing >60beats

Page 30: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

In-Use Checklist

S Complete q 30 min- must be stopped if unable

S At least 1 15x15 accel in 30 min or mod var for 10 of last 30 min.

S No more than one late

S No more than 2 variables > 60sec, or decreasing 60 beats in last 30 min

S No more than 5 ctx/10min averaged over 20 min.

S No 2 ctx greater than 120 secs

S Uterus palpates soft between ctx.

S If IUPC must be less than MVU <300mm Hg, resting tone <25mm Hg

Page 31: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Hard Stops

S FHR pattern does not meet criteria. If Dr. document no variables/lates can continue. If RN not agree chain of command. May be restarted at ½ when resolves.

S Oxygen. If resolves restart at ½.

S Continuous tracing. Interruptions >10min.

S Checklists

S Tachysystole (not irritability), decrease by at least 25%

Page 32: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Problems

S Same protocol, “different rules”

S New staff

S Lack of communication

S Lack of understanding of protocol

Page 33: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Future Data

S Rates of c/s with IOL

S Apgar outcomes

S NICU admissions

Page 34: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Questions?

Page 35: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission
Page 36: The New Pitocin Protocolwesleyobgyn.com/pdf/lectures/Pitocin Protocol.pdf · regimens for augmentation or induction of labor concluded high-dose oxytocin decreased the time from admission

Sources

S ACOG

S Uptodate

S HCA Perinatal Safety Initiative