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Management of Early Pregnancy Failures in the Outpatient Setting

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

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Management of Early Pregnancy Failures in the Outpatient Setting

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  1. 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. 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. Early Pregnancy Failures • Incidence: • 15-20% clinically recognized pregnancies • Estimated 30% if non-clinically recognized pregnancies are included* • 80% occur in first trimester * Wilcox NEJM1988

  4. 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. 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. 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. 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. Success of expectant management Luise C. BMJ 2002

  9. 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. Misoprostol: Physiologic Effects Uterine: Stimulate contractions Cervical Softens and primes cervix Gastrointestinal: Prevents/treats ulcers Nausea Vomiting Diarrhea Systemic: Fever

  11. Routes of Administration Oral Vaginal Buccal Sublingual Rectal

  12. 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. 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. 2005 *Tang, OS et al 2006 Middleton, T et al 2005

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

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

  20. Comparison of surgical with medical management: EPF • Zhang et al, 2005 • Prospective, RCT • 652 w/ 1st 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. 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. 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. 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 + 800 miso 24-48 hr • Primary outcome: infection within 14 days • Secondary outcome: efficacy (no D & C within 8 weeks) Tinder. BMJ 2006

  24. 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. Meta-analysis of Expectant, Surgical and Medical • Comparison of expectant, medical and surgical treatment of 1st 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. Meta-analysis of Expectant, Surgical and Medical, cont. • 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

  27. 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. CASES Discussions about Outpatient Management of Miscarriage

  29. 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. Case 1 Her medical history includes a spontaneous vaginal delivery 2002. 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. 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 12.2. • Urine pregnancy test: positive What tests do you think you should order now?

  32. 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. Case 1 Key ConceptsIncomplete/Inevitable Abortion • 600-800 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. 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. 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. Case 2 The patient returns 5 days later with further spotting and cramping. A 2nd 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. 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. Case 2 Key ConceptsAnembryonic Pregnancy • Consider the emotional aspects of miscarriage • Element of choice in patient satisfaction • Effectiveness of medication methods as well as surgical methods

  39. 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. 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. Case 3 Key ConceptsEctopic 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. MVA for Miscarriage Management in the Out-Patient Setting ARHP Workshop September 6, 2006 Emily Godfrey, MD MPH Michelle Forcier, MD MPH

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

  45. 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. MVA Safety & Efficacy • Hale 1979 (MVA in 1st trimester, gynecology office, Hawaii) • Edwards 1997 (MVA at < 6 weeks gestation, women’s clinic, Texas) • Westfall 1998 (MVA in 1st 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. Early Abortion with MVA Adapted from Baird and Flinn 2001

  48. 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 MVA vs EVA

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

  50. 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)

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