1. Oxytocin Protocols Essential Elements You Need to Include

2. Objectives Value of a Protocol Potential Problems ACOG Guidelines Pharmacologic considerations Power, Passenger, Passage Physiology of Labor Pulling it together

3. Value of Protocols In virtually every field of human endeavor studied, uniform processes lead to improved outcomes When several equally appropriate approaches exist in a given situation, a health care team that simply picks one good approach and implements it in the same way, time after time, will have better outcomes than a group of providers that approaches a given problem in a different way every time.

4. Value of Protocols Ambiguous guidelines leave much to interpretation; while potential justification for many types of practice may be inferred from such ambiguity, this lack of clarity also opens the door to endless debate as well as honest differences of opinion and testimony about how the guidelines should have been interpreted or applied in a specific situation.

5. Value of Protocols In addition to our primary goal of improving patient outcomes, such protocols, provided they are followed, offer a good deal of protection from litigation.

6. Potential Problems Oxytocin remains the drug most commonly associated with preventable adverse events during childbirth. Oxytocin is also frequently implicated in professional liability claims and thus poses a dual concern for individual clinicians and the organizations in which they practice.

7. Potential Problems Recently, oxytocin was added to the list of high- alert medications designated by the Institute for Safe Medication Practices (ISMP), a distinction reserved to only 11 other specific drugs. Such drugs are defined as those “bearing a heightened risk of harm when they are used in error” and that may “require special safeguards to reduce the risk of error.” Institute for Safe Medical Practices. High alert medications. (www. Ismp.org)

8. What Does ACOG Say? Not Much

9. ACOG Basic considerations for Induction – Maternal and fetal conditions – Gestational age – Cervical status

10. Maternal and Fetal Considerations Abruptio placenta Chorioamnionitis Fetal demise Gestational hypertension Preeclampsia, eclampsia PROM Post term pregnancy Maternal medical conditions Fetal compromise

11. Contraindications Vasa previa Transverse fetal lie Umbilical cord prolapse Previous classical delivery Active genital herpes Previous myomectomy entering the endometrial cavity

12. Logistic Indications Risk of rapid labor Distance from hospital Psychosocial indications In the above circumstances, at least one gestational age criteria must be met

13. Gestational Age

14. Cervical Status In the absence of a favorable cervix, the patient should be thoroughly counseled regarding – the indications for induction – the agents/methods of labor stimulation – Possible need for repeat induction and/or cesarean section – In the nulliparous patient, an unfavorable cervix should give pause if elective induction is being considered.

15. ACOG Any of the low or high dose regimens outlined are appropriate for labor induction. Each hospital’s obstetrics and gynecology department should develop guidelines for the preparation and administration of oxytocin.

16. ACOG A numeric value for the maximum dose of oxytocin has not been established. The FHR and uterine contractions should be monitored closely. Oxytocin should be administered by trained personnel

17. ACOG If something bad happens, try something different

18. Pharmacologic Considerations Onset of action of a given dose of oxytocin is relatively slow with a half life of 3-10 minutes and steady state levels at 40 minutes The therapeutic index is highly unpredictable. For any given dose of oxytocin, the effects may range from no effect to hypertonic contractions With rare exception, detrimental effects are exclusively generated by dose related effects on uterine activity.

19. Some thoughts……. Increasing the dosing of oxytocin at an interval significantly faster than steady state (40 minutes) is essentially a blind procedure in which additional drug is given before the full effects of the previous dose can be know. Because of the wide therapeutic index – The drug should be started at a relatively low dose – Dosing that involves locked-in increases without regard to uterine response are inappropriate

20. Some thoughts…. With persistent contraction frequency of 5 or more in a 10 minute period, there is a progressive decline in fetal O 2 saturation. Simpson and James. AJOG, 2008 Although the clinical significance of this is uncertain, if two protocols achieve equivalent clinical results, it seems that the protocol using lower infusion rates is preferable.

21. Physiology The synthetic oxytocin analog is based on the naturally occurring hormone. Correlation of oxytocin infusion rate to natural oxytocin levels in labor have been described. An infusion rate of 4-6 mU/min obtains serum levels similar to the spontaneous level of oxytocin during the first stage of labor. Fuchs, et al. AJOG, 1983

22. Physiology Most women achieve adequate contractions and deliver with an infusion rate of no more than 11-13 mU/min. There appears to be a difference in rate of cervical dilation from 4-10 cm in women requiring cervical ripening vs. spontaneous labor. Vahratian, et al. AJOG, 2005

23. Adequacy of Labor All management schemes based on contraction patterns draw conclusions drawn from inexact data. Two definitions of acceptable uterine contractions: – Achievement of 200-220 MVU’s – 1 contraction every 2-3 minutes, lasting 80-90 seconds and palpating strong by an experienced labor nurse

24. Adequacy of Labor Once these levels of uterine activity have been achieved, is there any justification for additional increases in oxytocin dose? At this point, if these defined levels of uterine activity do not result in reasonable progress, more time not more oxytocin is usually the better choice ACOG Practice Bulletin #49. Dystocia and the Augmentation of Labor. 2003.

25. Unfortunate Realities No other area of medicine so readily administers a potentially dangerous drug to accomplish a physiologic process that left alone would complete itself without the risk of drug administration. From a patient safety perspective, convenience as a driver of labor augmentation is counterintuitive.

26. Administration Variations Current guidelines for oxytocin administration are vague and dosing intervals vary by 200-300%. In comparing high dose and low dose protocols, no evidence exists that perinatal outcomes are improved with aggressive management of labor Metanalysis of aggressive protocols do not demonstrate a lower incidence of Cesarean delivery. Sadler. BJOG,2000.

27. Administration Variations High dose protocols have demonstrated increased incidence of tachysystole (up to ½ of patients) and increased incidence of Cesarean delivery for “fetal distress” Satin. Obstetrics and Gynecology, 1992 A metanalysis of 11 randomized trials demonstrated that low dose protocols not increased more frequently than every 30 minutes resulted in fewer episodes of tachysystole, higher vaginal delivery rate, lower infection rate and less postpartum hemorrhage than more aggressive regimens. Crane. J Obstetric Gynecol Can, 1998.

28. Administration Variations In one large hospital, implementation of a specific and conservative check-list based protocol for administration of oxytocin based on maternal and fetal response resulted in a significant reduction in maximum infusion rates of oxytocin and lower Cesarean rate without lengthening labor or increasing operative intervention. Clark. AJOG, November 2007.

29. Protocols Reduction of elective inductions.pdf Implementation of a conservative checklist.pdf

30. Conclusions There will be initial resistance! A protocol is only as good as its implementation. Hard stops must be in place so that variation from the protocol requires documentation as to the reason prior to proceeding. Should include evaluation of the passage, passenger and powers. Less is more in the administration of oxytocin.