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ARHP Management of Early Pregnancy Failures in the Outpatient Setting Emily Godfrey MD MPH Michelle Forcier MD MPH ARHP National Conference 2006 Pre-Conference.

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Presentation on theme: "ARHP Management of Early Pregnancy Failures in the Outpatient Setting Emily Godfrey MD MPH Michelle Forcier MD MPH ARHP National Conference 2006 Pre-Conference."— Presentation transcript:

1 ARHP Management of Early Pregnancy Failures in the Outpatient Setting Emily Godfrey MD MPH Michelle Forcier MD MPH ARHP National Conference 2006 Pre-Conference Workshop

2 ARHP Objectives Appreciate the historical context regarding terminology, diagnosis, and management of early pregnancy failure and how it has evolved Recognize the various presentations and classifications of early pregnancy failure List new and different treatment options currently available for early pregnancy failure Describe new data suggesting a role for misoprostol in the management of early pregnancy failure Describe the current standard treatment using MVA for early pregnancy failure

3 ARHP Early Pregnancy Failures Incidence: –15-20% clinically recognized pregnancies –Estimated 30% if non-clinically recognized pregnancies are included* 80% occur in first trimester * Wilcox NEJM 1988

4 ARHP Types of Early Pregnancy Failure Threatened Inevitable* –Uterine cramping –Dilated cervical os Incomplete* –Inevitable with passage of some POCs Missed* –Closed os –Uterine cramping Septic Complete –No uterine cramping –Cervical os closed –Complete passage of tissue * Early Pregnancy Failure

5 ARHP History of the Management of EPF Pre 1880 –Less is better Post 1880 –Development of curette –Reduction of hemorrhage –Reduction of infection –Intervention advocated because high rates of infection accompanying illegal abortion

6 ARHP Management of EPF Today –D & C still remains the standard of care despite decreased incidence of septic abortion –Potential complications Risk of anesthesia Uterine perforation Intrauterine adhesions Cervical trauma Pelvic Pain Increased risk of ectopic pregnancy (subsequent) Alternative treatment options –Manual vacuum aspiration –Medical management with prostaglandin analogues (i.e. Misoprostol)* –Expectant management

7 ARHP Expectant management In the setting of incomplete abortion expectant management is successful 82-96% of the time Average time to completion is 9 days Success rate is less for embryonic death or anembryonic gestations (missed abortions) (25-76%) First trimester miscarriages may be expectantly managed indefinitely if without hemorrhage or infections Griebel AFP 2005

8 ARHP Success of expectant management GroupNComplete day 7 Complete day 14 Success day 49 Incomplete (53%)185 (84%)201 (91%) Missed13841 (30%)81 (59%)105 (76%) Anembryonic9223 (25%)48 (52%)61 (66%) TOTAL (40%)314 (70%)367 (81%) Luise C. BMJ 2002

9 ARHP Misoprostol (Cytotec) Prostaglandin E1 FDA approved for prevention and treatment of gastric and duodenal ulcers Heat stable (does not need refrigeration) Inexpensive Widely available Oral preparation –100 g (non-scored) & 200 g (scored) tablets

10 ARHP Misoprostol: Physiologic Effects Uterine:Stimulate contractions CervicalSoftens and primes cervix Gastrointestinal:Prevents/treats ulcers Nausea Vomiting Diarrhea Systemic:Fever

11 ARHP Routes of Administration Oral Vaginal Buccal Sublingual Rectal

12 ARHP Vaginal Use Manufactured and approved for oral use only Greater effects on reproductive tract with vaginal dosing* Decreased gastrointestinal side effects with vaginal dosing* *Danielsson 1999 Creinin 1993 Toppozada 1997

13 ARHP Buccal & Sublingual Use Mostly been studied with the use of induced medical abortion Sublingual has faster absorption than buccal* Buccal as effective as vaginal in induced medical abortion up to 56 days gestation Sublingual as effective as vaginal misoprostol in induced medical abortion up to 63 days gestation *Schaff, EA et al *Tang, OS et al 2006 Middleton, T et al 2005

14 ARHP Surgical options Sharp curettage (D and C) no longer an acceptable option due to higher complication rates Vacuum aspiration includes manual vacuum aspiration (MVA) vs. electrical pump aspiration

15 ARHP MVA Instruments and Supplies Inexpensive Small Portable Quiet Specimen likely to be intact May require repeated reloading of suction

16 ARHP Literature Review Standard dosage and dosing intervals have not been well established Studies difficult to compare –Various patient populations and dosing regimens –Different routes of administration –Varying definitions of success

17 ARHP Incomplete and Missed AB Demetroulis et al, 2001 Prospective RCT 80 women w/missed AB or incomplete AB Misoprostol vs. Surgical evacuation Results: –82.5% successful in Misoprostol group –Failure rate higher for Missed AB patients (23% v. 7%) Demetroulis. Human Reproduction, 2001

18 ARHP Missed Abortion Wood et al, 2002 Double blind randomized controlled trial (Type I study) 50 women –Ultrasound dx of missed ab –Absence of cramping and bleeding –Less than 12 weeks uterine size 800 g misoprostol – up to 2 doses –Vaginal versus placebo Follow-up –24 hours, 48 hours, 1 week Wood and Brain, Obstet Gynecol 2002

19 ARHP Missed Abortion Misoprostol –15 of 25 completed after first 24h –21 of 25 completed after second 48h –2 had on-going bleeding –1 had retained tissue Placebo –1 of 25 completed 48h –4 of 25 1 week No significant change in hemoglobin levels Wood and Brain, Obstet Gynecol 2002

20 ARHP Comparison of surgical with medical management: EPF Zhang et al, 2005 Prospective, RCT 652 w/ 1 st trimester pregnancy failure –Anembryonic –Embyronic or fetal death –Incomplete –Inevitable Misoprostol 800 g, repeat day 3 –Vaginal versus surgical evacuation Complications –Surgical treatment for the miso group –Repeat surgical procedure within 30 days Zhang. NEJM 2005

21 ARHP Comparison of surgical with medical management: EPF Results –Misoprostol Group 71% complete by Day 3 84% complete by Day 8 –Treatment Failure 16% Misoprostol group 3% Surgical group Conclusions –Treatment of EPF with Miso is safe and works about 84% of the time Zhang. NEJM 2005

22 ARHP Missed Abortion Using Sublingual Misoprostol Tang, et al, 2006 Prospective randomized controlled trial 180 women –Ultrasound dx of missed ab –Absence of cramping and bleeding –Less than 13 weeks uterine size 600 g sublingual misoprostol Q 3 hours x 3 vs 400 g sublingual misoprostol daily x 1 week Results at 1 week –92% completed in SL x 3 group –93% complete in SL x 3 + daily group Greater side effects reported in the SL x 3 + daily group Tang. Hum Reprod 2006

23 ARHP Early Pregnancy Failure Treatment Using Mifepristone/Misoprostol Trinder, et al, 2006 Prospective randomized controlled trial Miscarriage Treatment Trial (MIST) 1200 women –Less than 13 weeks gestation –Incomplete miscarriage, Anembryonic, Missed abortion Expectant vs. Medical vs. Surgical Incomplete: 800 miso only vaginal Anembyronic/Missed: 200 mife miso hr Primary outcome: infection within 14 days Secondary outcome: efficacy (no D & C within 8 weeks) Tinder. BMJ 2006

24 ARHP Early Pregnancy Failure Treatment Using Mifepristone/Misoprostol Results –Gynecological Infection No difference between the groups –Anembyronic/Missed 6% Surgical group 38% Medical group 50% Expectant group Conclusions –Infection rates did not differ between groups –Surgical Management is more treatment option than medical or expectant management Tinder. BMJ 2006

25 ARHP Meta-analysis of Expectant, Surgical and Medical Comparison of expectant, medical and surgical treatment of 1 st trimester spontaneous abortion 28 studies eligible for analysis Medical v. expectant: expectant was 39% successful. Medical 3 times more likely to be successful Sotiriadis. Obstet Gynecol 2005

26 ARHP Surgical v. expectant: expectant was 79% Surgical more likely to be successful than expectant Surgical v. medical: surgical was 1.5 times more successful than medical Pt satisfaction did not differ significantly between surgical and medical, although trend favored medical management Sotiriadis, Obstet Gynecol 2005 Meta-analysis of Expectant, Surgical and Medical, cont.

27 ARHP Conclusion Early pregnancy failure is common Expectant, medical and surgical management can be done safely in an outpatient setting Study findings vary because of lack of uniformity of study populations Patients should be counseled accordingly so they can choose best treatment option

28 ARHP CASES Discussions about Outpatient Management of Miscarriage

29 ARHP Case 1 You see a 18-year old woman, G2P1001, whose last period was 8 weeks ago. She had a positive home pregnancy test 3 weeks ago. Her first prenatal appointment is scheduled with another provider. She has not had an ultrasound during this pregnancy. Three days ago, she began to spot. Today, her bleeding has increased, like a very heavy period with some clots. She began cramping last night and now reports that the cramping is severe. She comes to your clinic today for assessment and treatment if required.

30 ARHP Case 1 Her medical history includes a spontaneous vaginal delivery She is otherwise healthy. On exam, she appears comfortable and is able to walk around the room and talk easily. Her vital signs: BP 110/70, Pulse 90, Temp 97.8 At this point, how would you proceed with evaluation?

31 ARHP Case 1 The examination reveals the following –Abdomen: soft, nontender –Vaginal vault: scant amount of blood, consistent with a menses –Cervix: os open, tissue at os noted –Bimanual exam: uterus enlarged, approx. 8 weeks size, nontender Her hemoglobin is Urine pregnancy test: positive What tests do you think you should order now?

32 ARHP Case 1 The ultrasound reveals an intrauterine gestational sac, and thickened endometrial stripe. What is the diagnosis? What are the treatment options available for this patient?

33 ARHP Case 1 Key Concepts Incomplete/Inevitable Abortion mcg effective dose without too many side effects May give vaginally, orally, sublingual (not well studied) May repeat More effective for incomplete abortions than for missed abortions

34 ARHP Case 2 41 yo G1P1 presents to the Clinic for her first prenatal visit in a very desired pregnancy. Her LMP was 10 weeks ago and she is certain of her dates. The pregnancy has been uncomplicated except for a small amount a bleeding she had about 1 week ago. You evaluate the patient and finds that her BM exam is consistent with a 7 wk IUP, os is closed. What other information might you be interested in knowing about? What might you order to get a diagnosis?

35 ARHP Case 2 Fortunately, your Clinic has a portable ultrasound, and you are able to supervise the resident with a vaginal probe ultrasound. You see a well-circumscribed, though empty gestational sac. What are your differential diagnoses? What do you tell the patient?

36 ARHP Case 2 The patient returns 5 days later with further spotting and cramping. A 2 nd serum β-hCG is done, as well as a repeat ultrasound. The ultrasound now shows a large irregular shaped gestational sac. The serum β-hCG level has dropped. What is your assessment?

37 ARHP Case 2 The patient decides to opt for medical treatment. What regimen do you use? How do you advise her? What can she expect?

38 ARHP Case 2 Key Concepts Anembryonic Pregnancy Consider the emotional aspects of miscarriage Element of choice in patient satisfaction Effectiveness of medication methods as well as surgical methods

39 ARHP Case 3 26 yo G2P2002 LMP uncertain because of irregular periods well known to you presents to your office with spotting x 4 days. She denies any pain. Her urine pregnancy test is positive, her cervical os closed. Her uterus is retroverted. She has a remote history of Chlamydia infection about 10 years ago. What is your differential diagnosis? What tests would you order now?

40 ARHP Case 3 You perform an ultrasound and you see small echolucent area, which could be a small gestational sac or a pseudosac. What should you do now? What is your diagnosis? What are you options for treatment?

41 ARHP Case 3 Key Concepts Ectopic Pregnancy Ectopic vs early pregnancy may be hard to differentiate Methotrexate an option for early & stable patients MVA can help evaluate POC in clinic, guiding diagnosis & referral decisions

42 ARHP MVA for Miscarriage Management in the Out-Patient Setting ARHP Workshop September 6, 2006 Emily Godfrey, MD MPH Michelle Forcier, MD MPH

43 ARHP Updates in Miscarriage Management To discuss issues in evaluation & management of early miscarriage To discuss the evidence behind the options for miscarriage management To review manual vacuum aspiration (MVA) for miscarriage management –Summarize the safety and efficacy of MVA –Discuss pain management in out-patient settings –Discuss moving miscarriage management out of OR To demonstrate technique or update your skills in MVA for uterine evacuation

44 ARHP What is MVA? Goldberg 2004; Creinin 2001; Hemlin 2001 Manual vacuum aspirator Semi-flexible plastic cannula Portable & reusable Efficacy = electric vacuum (98-99%)

45 ARHP Indications for MVA Uterine evacuation first trimester –Induced abortion –Spontaneous abortion or early pregnancy failure (EPF) Complications management –Incomplete medical abortion –Post-abortal hematometra Uterine sampling –Endometrial biopsy

46 ARHP MVA Safety & Efficacy Hale 1979 (MVA in 1 st trimester, gynecology office, Hawaii) Edwards 1997 (MVA at < 6 weeks gestation, womens clinic, Texas) Westfall 1998 (MVA in 1 st trimester, family practice office, Colorado) Hemlin 2001 (EVA vs. MVA at < 8 weeks gestation, hospital operating room, Sweden) Paul 2002 (EVA and MVA at < 6 weeks, Planned Parenthood, Massachusetts) Goldberg 2004 (EVA vs. MVA up to 10 weeks, University of California, San Francisco)

47 ARHP Early Abortion with MVA AuthorDateNGestational Age Efficacy Paul et al.20021,132 (MVA+EVA)<698% Edwards & Carson 19971,530 MVA<699% Edwards & Creinin 19972,399 MVA<6<699% Hemlin & Moller MVA<898% Laufe197712,888About 698% Adapted from Baird and Flinn 2001

48 ARHP MVA vs EVA EVA Electric pump Costly but longer life Variable noise level Not easily portable Capacity: 350-1,200 cc Constant suction Fragmentation of POCs MVA Manual aspirator Inexpensive Quiet Portable Capacity: 60 cc Suction decreases as aspirator fills POCs likely intact

49 ARHP Complications with MVA Rare Same as for EVA –Incomplete evacuation –Uterine or cervical injury –Infection –Hemorrhage –Vaso-vagal reaction

50 ARHP MVA for Miscarriages Aspiration recommended if –Prolonged or excessive bleeding –Signs of infection –Patient preference Advantages –Portable & low cost device –Suitable for outpatient services –Applications to variety of settings (primary care, ob/gyn office, ER)

51 ARHP Patient Satisfaction Both EVA and MVA groups highly satisfied No difference reported in –Pain –Anxiety –Bleeding –Acceptability & satisfaction More EVA patients bothered by noise (p=0.03) Bird et al. 2003, Dean et al. 2003, Edelman et al. 2001

52 ARHP MVA Instruments

53 ARHP MVA: Key Benefits Safety & efficacy equivalent to EVA Portable Low tech Low-cost Small and quiet Significant implications for incorporating services into the office setting Dalton and Castleman 2002; Goldberg et al. 2004

54 ARHP MVA: Essentials for Providers Pain management for awake patient Counseling & rapport Ultrasound Identifying products of conception Instrument processing

55 ARHP Video of MVA Procedure

56 ARHP MVA Video- Important Points?

57 ARHP Video – Important Points Actual patient from local outpatient clinic Ibuprofen and paracervical block only In procedure room time ~10-15 minutes Actual time for uterine evacuation ~1-2 minutes Recovery time ~30 minutes

58 ARHP Pain Management In the Out Patient Setting

59 ARHP Pain Management in Outpatient Settings Staff often express concern that uterine evacuation requires general or conscious sedation Many uterine evacuations done under paracervical (local) block Definite ways you can improve pain management in your outpatient setting

60 ARHP Pain Management Techniques With Addition Of: Focused breathing: 76% Visualization: 31% Localized massage: 14% Lichtenberg 2001

61 ARHP Importance of Pain Management Most common concern expressed by patient Highly linked to patient satisfaction Whose perspective? – Patients –Clinician –Counselor/bedside assistant What are we trying to do? –Minimize risk / maximize benefit –Take away all pain/all feeling –Get through it

62 ARHP Effective pain management What worsens pain? –Pre-procedure fearfulness –Anxiety –Depression What reduces pain? –Respectful, informed and supportive staff –Warm and friendly environment –Gentle operative technique –Womens involvement & sense of control –Effective pain medications Belanger 1989; Smith 1979

63 ARHP Other Influences on Pain Provider –The clinician has a profound effect on pain score, independent of anesthetic (Rawling 1998 and 2001) Patients sense of control –The idea that I could manage the miscarriage myself with guidance available whenever I needed it…I felt calmer, more confident, less medicated and out of control. (Wiebe 1999)

64 ARHP Role Play- Patient Centered Care 23 yro G1P0 miscarrying at EGA 8 weeks Very desired pregnancy Bleeding and cramping x 24 hrs No fetal heart activity & CRL only measuring 5 weeks

65 ARHP Paracervical Block Maltzer 1999; Castleman 2002

66 ARHP Options for Anesthesia Local Conscious sedation Other –Psychological Information, preparation & support –Music as analgesia 85% abortion patients wearing headphones rated pain as 0 compared to 52% controls –Distraction Stubblefield 1989 Shapiro 1974

67 ARHP Curettage and Pain Using the curette often requires increased dilatation Curetting hurts! Makes reducing anesthesia more difficult Sharp curettage generally not indicated & not routinely recommended following MVA Forna 2002

68 ARHP In Conclusion... No pain panacea –Affirm the patients existing viewpoint wherever possible –Avoid glib reassurances –Advise the patient that her fears are widely shared –Help the patient to differentiate between emotional and physical pain Women want to be involved in developing their pain management plan Curette check hurts - usually not needed Pre-procedure preparation & psychological support reduce anxiety & improve overall experience

69 ARHP Other Clinical Benefits of MVA POCS are easier to visualize & inspect –Often more intact –Easier detection of early EGA Fewer re-aspirations in MVA vs EVA group (Goldberg 2004) –Can still send to pathology for genetics Goldberg 2004; MacIsaac 2000; Edwards 1997

70 ARHP MVA POC Check: Benefits for EPL Creinin and Edwards 1997 Electric Suction Machine MVA Aspirator What is that? There it is!


72 ARHP Uterine evacuation- Why the OR? OR was necessary when emptying the uterus was an emergency –Abortion was illegal –Antibiotics were not available –Access to blood transfusion limited Puerperal (childbed) fever was the scourge of nineteenth century obstetrics and abortion. Joffe 1999 Today, out patient care safe, convenient, cost effective option for stable patients

73 ARHP OR to Out Patient Clinic – Benefits Simplify scheduling Reduce waiting and repeat exams Avoid cumbersome OR protocols Prolonged NPO requirements & discharge criteria Save resources Outpatient saves materials required, costs/charges, personnel Demetroulis 2001

74 ARHP Out Patient - Benefits to your Patients Why some patients want MVA Control/autonomy while awake during procedure Convenience & time –Single appointment –Rapid recovery time Personalized care by single provider Improved patient education, attitudes, accommodations in out patient setting (Lee 1996)

75 ARHP Moving Miscarriage Management to Outpatient Setting – Johns Hopkins Study Results –Decreased anesthesia requirements –Decreased overall hospital stay from 19 to 6 hours –Decreased patient waiting time by 52% –Decreased procedure time from 33 to19 minutes –Decreased costs per case $1404 in OR $827 in L&D $200 or less in ER Blumenthal 1994

76 ARHP Moving Abortion to an Outpatient Clinic - Bellevue Hospital Methods Compared costs, staff, complications: OR vs. Outpatient N = 967; Patients undergoing first trimester pregnancy termination in outpatient procedure room ( ) Results Bellevue Hospital Improvement Reports, Masch 2002 Outpatient MVA Operating Room Cost per Procedure $167$1,435 Staff25 No reported complications with outpatient MVA $1268 savings

77 ARHP Moving Abortion to an Outpatient Clinic- University of Michigan Results: 60 women chose clinic, 29 women chose OR MVA: 91% would choose again get home soon, avoid GA 69% less patient time 50% shorter procedure time Dalton 2003 Cost savings of moving out of the OR of $3,000 per case

78 ARHP Medications/Supplies Needed Analgesia Anesthetic Silver nitrate or ferric subsulfate Uterotonic agent Rhogam Urine pregnancy tests Emergency cart Pharmacologic agents for cervical ripening (optional)

79 ARHP Equipment Needed PROCEDURE Aspirators Cannulae Speculae Sharp-toothed and/or atraumatic tenaculae Antiseptic solution Mechanical dilators 20-cc syringe for local anesthesia TISSUE EXAMINATION Basin for POC Fine-mesh kitchen strainer Back light Tools to grasp tissue and POC Specimen containers

80 ARHP Finances Behind Out Patient Tx Diagnosis code: (Spontaneous Abortion, without mention of complication) CPT Billing codes for in office management vs in patient management –59812 – Treatment of incomplete abortion, any trimester, completed surgically –59820 – Treatment of missed abortion, completed surgically, first trimester Reimbursement issues

81 ARHP Conclusions Evidence demonstrates Uterine evacuation can be managed safely in an out-patient clinic setting Moving out of the operating room –Saves both time, money, resources –Offers significant both choice & advantages to both women & clinicians

82 ARHP Never, ever, think outside the box.

83 ARHP CASES Discussions about MVA For Outpatient Management of Miscarriage

84 ARHP Case 1 continued The same 18 yro G2P1001, experiencing mild- moderate cramping with mild-moderate bleeding in your clinic, and an ultrasound evidence of an incomplete abortion elects an MVA procedure as she wants to take care of this as soon as possible. You are performing the MVA-all seems to be going well. However, the aspirator is only about one-quarter full and you remember from this course that at this gestational age, you would expect more tissue than this. You are not sure whether or not you are done.

85 ARHP Case 1 continued How can you tell if you are done? List 4 signs suggesting completion. What do you do? For bonus credit---at what pregnancy age does the volume of POC become more than 60 cc (equivalent to the volume of the aspirator)?

86 ARHP MVA Key Concepts MVA safe & effective for early pregnancy loss in first trimester Allows for care that day, in the office, with their primary provider Any uterine evacuations efficacy is improved by systematically checking for completion

87 ARHP Case 2 continued 41 yo G2P1001 with an LMP suggesting a 10 week pregnancy but ultrasound findings revealing anembryonic pregnancy. The patient decided to opt for medical treatment. She took both mifepristone and misoprostol and is now seeing you for her routine follow-up visit, scheduled 2 weeks after she took mifepristone. She has been having persistent spotting, and says that she is really sick of it. Vaginal ultrasound reveals a non-viable, persistent gestational sac. Specifically, there is no evidence of growth but the sac is still present.

88 ARHP Case 2 continued You counsel her about options, including observation, repeating misoprostol, and surgical completion. The woman has significant childcare problems and wants to minimize the number of visits she must make to your clinic. Therefore, she requests surgical completion.

89 ARHP Case 2 continued You perform MVA and are partway through the aspiration when you note that the cannula seems to be sliding back and forth over the uterine lining too easily; it feels like nothing is happening. What could be going on? What do you do to test your answer to question #1? How might MVA on this patient be different from that performed on surgical abortion patients who have not received mifepristone or misoprostol?

90 ARHP MVA Key Concepts Helpful to trouble shoot & know how to solve common MVA problems Lack of suction can caused by –Device not assembled or working properly –Clogged cannula Can never go wrong by stopping & reassessing

91 ARHP Case 3 continued 26 yo G2P2002 LMP uncertain because of irregular periods is at your office for pregnancy termination with either early intrauterine versus ectopic pregnancy in the differential. She would like to deal with it today and with you if possible. You want to make sure it is not an ectopic pregnancy….

92 ARHP Case 3 continued Initially, dilitation of the cervix seems slightly more difficult than usual. However, after the first two dilator passes, it then progresses uneventfully. A 6 mm cannula is placed in the os, the aspirator is connected, and only scant blood is obtained. Dilitation for correct placement is attempted again. Again, only scant blood is obtained. What do you think is happening? What do you do now?

93 ARHP MVA Key Concepts Checking device & placement helpful when not getting scant or no products back Ultrasound helps assess placement of cannula MVA can be help diagnose ectopic pregnancy Floating products of conception very helpful in assessing uterine contents (and is easy to do)

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