1. Ensuring a Safe Outcome With Vacuum Delivery NNEPQIN Fall Meeting November 14,2009 Jerome Schlachter, MD

2. No disclosures to report

3. Acknowledgement Perinatal Community Vacuum Delivery Bundle Peter Cherouny, M.D. Division of Maternal-Fetal Medicine Department of Obstetrics and Gynecology University of Vermont College of Medicine Quality Care in Obstetrics Preventing Trauma with Vacuum Delivery

4. Objectives 1. Describe specific risks associated with vacuum delivery. 2. Describe technical considerations for employing a vacuum device. 3. Explain rationale for developing a clinical bundle of care elements for vacuum delivery. 4. List 5 vacuum delivery bundle elements.

5. Clinical Case Review: 20 y.o. G1 P0 at 40 weeks presents in labor dilated 5-6 cm.

6. Rapid progress to full dilatation, pushing begins. Meconium is noted.

7. With concern about the fetal status, provider #1 applies a vacuum.

8. Minimal descent occurs and provider #2 is called. With pulls over two contractions there is descent to +1.

9. The patient pushed for 10 minutes, bringing the vertex to +2 station. The vacuum was employed again over two contractions. The caput was starting to crown. The position was noted to be OP.

10. Forceps were placed and delivery was accomplished with the first pull. A shoulder dystocia was encountered, relieved easily with McRobert’s position and gentle traction. A live infant was delivered. Weight = 2940 grams APGAR scores = 2, 6 and 8. Arterial Cord pH = 7.07, BE = -14.1 A large 4 th degree laceration was repaired.

11. The Whole Story The newborn spent 17 days in the NICU with cephalohematoma, small subdural hematoma, meconium aspiration, anemia, jaundice, r/o sepsis, TPN. At 8 mo. there is residual calcification of the cephalohematoma, but normal growth and development. The mother considers the delivery a traumatic experience and questions why a cesarean was not performed earlier. She is requesting sterilization.

12. Elliot Hospital FY 2008 32 babies were discharged with a diagnosis of “Birth trauma, injury to the scalp”.

13. Elliot Hospital FY 2008 109 Vacuum Deliveries (4.7%) 5* Forceps Deliveries *3 of 5 followed use of vacuum

14. Incidence of Operative Vaginal Birth in U.S., 1989-1997

15. Vacuum Extraction: Indications Standard Indications Standard Indications  Prolonged 2 nd stage of labor  Fetal compromise, non-reassuring fetal status  Shortening of 2 nd stage for maternal benefit Nonstandard indications Nonstandard indications  Umbilical cord prolapse  Fetal compromise in multip, near fully dilated  Suspected borderline CPD  Delivery of second twin above 0 station Miksovski,OBGYN Surv. 2001

16. Vacuum Extraction: Prerequisites Cephalic presentation Cephalic presentation Full cervical dilatation Full cervical dilatation Engaged fetal head (at or below 0 station) Engaged fetal head (at or below 0 station) Ruptured membranes Ruptured membranes Experienced operator present Experienced operator present Operator certain about the position of fetal head Operator certain about the position of fetal head Capability to perform emergency cesarean delivery Capability to perform emergency cesarean delivery Miksovski,OBGYN Surv. 2001

17. Vacuum Extraction: Contraindications Premature fetus (GA < 34-36 weeks) Premature fetus (GA < 34-36 weeks) Fetus with bone demineralization condition (e.g. osteogenesis imperfecta) Fetus with bone demineralization condition (e.g. osteogenesis imperfecta) Fetal hemorrhagic diathesis Fetal hemorrhagic diathesis Face presentation Face presentation Cephalopelvic disproportion Cephalopelvic disproportion Position of fetal head unknown (ACOG) Position of fetal head unknown (ACOG) Miksovski,OBGYN Surv. 2001

18. Procedures That Hasten Delivery AmniotomyVacuum

19. Quality Care in Obstetrics Birth Trauma related to Vacuum Delivery What we cause –Scalp laceration –Retinal hemorrhage –Cephalohematoma –Subgaleal hemorrhage –Intracranial hemorrhage –Hyperbilirubinemia –Maternal trauma

20. Newborn Cranial Spaces

21. Extracranial Injuries Scalp bruising16% Scalp bruising16%  Usually resolve without sequellae Chignonhigh Chignonhigh  Usually resolve without sequellae Cephalohematoma6-10% Cephalohematoma6-10%  Usually resolve without sequellae Subgaleal hemorrhage<1% Subgaleal hemorrhage<1%  Shock, DIC, organ failure, death in 25% Doumouchtsis, Clin.Perinat. 2008

22. Cephalhematoma vs. Subgaleal Hematoma

23. Cephalhematoma and Subdural Hematoma

24. Subgaleal hematoma in a newborn.

25. Cranial Injuries Fractures Linear skull fractures Linear skull fractures  0.5% incidence estimated  5% incidence on screening x-ray  Usually resolve without sequellae Depressed skull fractures Depressed skull fractures  Rare with vacuum  More common with forceps  Associated with IC hemorrhage and neurologic complications Doumouchtsis, Clin.Perinat. 2008

26. Intracranial Injuries Intracranial Hemorrhage Estimated incidence at term 0.11% - 0.34%. Estimated incidence at term 0.11% - 0.34%. Incidence with screening ultrasound after vacuum 0.87%. Incidence with screening ultrasound after vacuum 0.87%. Similar incidence with cesarean alone. Similar incidence with cesarean alone. Associated with birth asphyxia, prematurity, infection, vascular abnormalities, hemorrhagic diathesis. Associated with birth asphyxia, prematurity, infection, vascular abnormalities, hemorrhagic diathesis. If VD, location is usually subdural or subarachnoid. If VD, location is usually subdural or subarachnoid. Doumouchtsis, Clin.Perinat. 2008

27. Quality Care in Obstetrics Birth Trauma related to Vacuum Delivery ACOG Conclusions –“Serious complication of vacuum device in approximately 5% of vacuum attempts.” –“Given the maternal and fetal risks associated with operative vaginal delivery, it is important that the patient be made aware of the potential complications of the proposed procedure” ACOG Practice Bulletin No. 17. June, 2000

28. If you have to inform a mother of a 5% risk of serious complications associated with vacuum delivery, can you do anything to reduce the risk? What are the factors that are associated with increased risk of trauma?

29. Quality Care in Obstetrics Birth Trauma related to Vacuum Delivery How we cause it –Unnecessary procedure –High risk procedure –Inadequate skill of provider –Unknown fetal parameters –Prolonged application or multiple pop-offs –No alternative delivery options available

30. Vacuum Application

34. Vacuum Extraction: Technique Cup application over the “flexion point”. Cup application over the “flexion point”. Pressure 550-600 mm Hg = 11.6 psi. Pressure 550-600 mm Hg = 11.6 psi. Raise pressure to “yellow”, check placement, then raise to “green”. Raise pressure to “yellow”, check placement, then raise to “green”. Traction, during uterine contractions, in the axis of the birth canal. Traction, during uterine contractions, in the axis of the birth canal. Miksovski,OBGYN Surv. 2001

35. Vacuum Extraction: Technique Duration of vacuum Duration of vacuum –15-30 minutes, most favoring 15-20. –10 minutes of high pressure if pressure lowered between contractions. Pop-offs Pop-offs –One occurs in 16-38% of cases –Limits of 3 recommended –Likely is a sign of misapplication or CPD Miksovski,OBGYN Surv. 2001

36. Baskett T, JOGC, July 2008 Parameter Total (N = 1000) Spines + 2 or +3 75% Spines + 4 15% Occiput anterior at application 87% Occiput anterior at delivery 93% Applied at flexion point 50% Applied paramedian 47% Duration of application < 10 min 97% Number of pulls > 3 4% Number of pop-offs >1 7% Successful vacuum delivery 87%

37. Baskett T, JOGC, July 2008 Outcome Measure Total (N = 1000) 3rd/4th Degree Tear : Epis./No Epis. 16%/6% Scalp “markings” 65% Minor scalp trauma 11.4% Shoulder dystocia 5.6% BP injury 0.3% ICH0.4% Subgaleal hemorrhage 0.1% Forceps following vacuum 9.8% Cesarean following vacuum 2%

38. Simonsen, et. al. 913 successful term vacuum births. 913 successful term vacuum births. Limits: Vacuum discontinued if Limits: Vacuum discontinued if  no progress in 3 pulls,  no delivery in 8 pulls, or  2 pop-offs. All infants evaluated by transfontanellar ultrasound and skull x-ray All infants evaluated by transfontanellar ultrasound and skull x-ray Obstet.Gynecol, 2007, 109, 626-33

39. Simonsen, et. al. Fetal Morbidity Encountered in the Studied Cohort (n913) of Successful Vacuum Extractions of Term Newborns n % 95% CI Fracture46 (5.04) (0.59–6.49) Scalp edema 171(18.73) (16.15–21.31) Cephalhematoma 99 (10.84) (8.79–12.90) Intracranial hemorrhage 8 (0.87) (0.26–1.49) Higher incidence with nulliparity, pop-offs, higher fetal station, fetal macrosomia Obstet.Gynecol, 2007, 109, 626-33

40. Quality Care in Obstetrics Birth Trauma related to Vacuum Delivery Effect of Method of Delivery on Neonatal Injury MethodDeathICHOther* SVD1/5,0001/1,9001/216 C/S labor1/1,2501/9521/71 C/S after OVD1/3331/38 C/S no labor1/1,2501/2,0401/105 Vacuum alone1/3,3331/8601/122 Forceps alone1/2,0001/6641/76 Vacuum and forceps1/1,6661/2801/58 *Facial nerve/brachial plexus injury, convulsions, central nervous system depression, mechanical ventilation Towner D, Castro MA, Eby-Wilkens E, Gilbert WM. Effect of mode of delivery in nulliparous women on neonatal intracranial injury. N Engl J Med 1999;341:1709–1714

41. ACOG Recommendations Unless the preoperative assessment is highly suggestive of a successful outcome, trial of operative vaginal delivery is best avoided. Unless the preoperative assessment is highly suggestive of a successful outcome, trial of operative vaginal delivery is best avoided. The weight of available evidence appears to be against attempting multiple efforts at OVD with different instruments, unless there is a compelling and justifiable reason. The weight of available evidence appears to be against attempting multiple efforts at OVD with different instruments, unless there is a compelling and justifiable reason. ACOG Practice Bulletin 17, June 2000

42. Knowing what you know, what interventions could be considered to ensure the safest outcome for vacuum delivery at your hospital?

43. Quality Care in Obstetrics Preventing Trauma with Vacuum Delivery Preliminary considerations –Consider alternative management –High chance of success –Exit strategy prepared –Prepared patient  Informed consent –Resuscitation team available

44. Quality Care in Obstetrics Preventing Trauma with Vacuum Delivery Technical considerations –Fetal parameters known and considered  EFW, Station, Position –Application time and pop-offs limited –Traction in direct line of birth canal  No rocking movements

45. How could you “package” a plan of care?

46. Quality Care in Obstetrics Preventing Trauma with Vacuum Delivery Bundle Components –Individual components supported by science –Required to be performed for every patient, every time –Bundle compliance measured by fulfilling all parts of the bundle –Focus on system

47. Quality Care in Obstetrics Preventing Trauma with Vacuum Delivery Vacuum Bundle –Alternative labor strategies considered –Prepared patient  Informed consent discussed and documented –High probability of success  EFW, fetal position and station known –Maximum application time and number of pop-offs predetermined –Exit strategy available  Cesarean and resuscitation team available

48. Bundle Elements Applied to our Clinical Case Alternative strategies considered Alternative strategies considered –Should cesarean have been done initially? Informed consent of the patient Informed consent of the patient –Didn’t document, didn’t occur. EFW, position, station known EFW, position, station known –Not really known, not documented. Vacuum time and pop-offs predetermined Vacuum time and pop-offs predetermined –No policy in place, was not monitored during application. Exit strategy in place Exit strategy in place –Was move to forceps “compelling and justifiable”? –C/S team was not prepared.

49. What tools do you need to implement your “package”?

50. Vacuum Communication “Time Out” Pre-procedure briefing: Pre-procedure briefing: –In the presence of the patient?  Alternative strategies?  Informed consent?  High probability of success?  Limits clear?  Exit strategy in place? Post-procedure debriefing: “What went well? What could be done differently?” Post-procedure debriefing: “What went well? What could be done differently?”

51. Vacuum Checklist  Alternative labor strategies discussed  Informed consent discussed and documented  Document before delivery  EFW  Fetal position  Station  Document during delivery  application time (limit pre-determined)  number of pop-offs  Cesarean and resuscitation team available