Objectives

3. Identify expected side effects and possible complications of medical abortion Discuss the management of the side effects and complications of medical abortion Objectives

4. Background: safety, definitions, counseling issues “Expected” side effects and their management Complications and their management Case studies Overview

5. Mifepristone/misoprostol Impressive safety record in 400,000 U.S. women Used safely by millions of women worldwide Methotrexate/misoprostol More than 5,000 cases in the published literature Used safely by tens of thousands of women Misoprostol alone Important option where mifepristone and methotrexate are not available or affordable Outstanding Safety Record

7. Side Effect Effect of treatment, other than the intended outcome, that might include physiological or psychological consequences Complication Effect resulting from treatment that has potentially serious clinical consequences and requires medical intervention Definitions

8. Women will be more involved in the process of medical abortion as compared to vacuum aspiration Preparing women for side effects is a critical component of counseling The quality of counseling correlates with the level of patient satisfaction with abortion care Abortion Counseling

9. Vacuum aspiration Serious complications rare and usually result from anesthesia or instrumentation of the uterus Side effects rarely reported Medical abortion Serious complications rare Most side effects are medication-induced: nausea, vomiting, diarrhea, fever Process of aborting has “side effects” Abortion Counseling

10. Background: safety, definitions, counseling issues “Expected” side effects and their management Complications and their management Case studies Overview

11. Pain Bleeding Nausea, vomiting, diarrhea Short-term temperature elevation or chills Headache, dizziness Expected Side Effects of Medical Abortion

12. Cramping occurs in > 90% of patients1 Provide pain medications with initiation of treatment Counseling and reassurance crucial to pain management 1Spitz, et al. New Engl J Med 1998 Management of Common Side Effects: Pain

13. Medications for pain control Non-narcotic analgesics Acetaminophen NSAIDs—can be used with misoprostol Narcotic analgesics Palliative measures Heating pad Hot water bottle Relaxation techniques Management of Common Side Effects: Pain

14. Usually exceeds typical menstrual bleeding If patient saturates 2 maxipads/hour for 2 consecutive hours, contact provider Surgical intervention to control bleeding: 0.4% to 2.6%1,2 Transfusion required: 0.2%2 Longer duration than with vacuum aspiration No significant difference in total blood loss between medical abortion & vacuum aspiration Management of Common Side Effects: Bleeding 1Ashok, et al. Hum Reprod 1998 2Spitz, et al. New Engl J Med 1998

15. Usually short in duration Provide reassurance Rarely needs medication Management of Common Side Effects: Nausea, Vomiting, and Diarrhea

17. Result of misoprostol or the abortion process Antipyretics as appropriate Suspect infection with: Sustained fever > 100.4°F Fever 24 hours or more after misoprostol Management of Common Side Effects: Fever/Chills

18. Background: safety, definitions, counseling issues “Expected” side effects and their management Complications and their management Case studies Overview

19. Continuing pregnancy Persistent gestational sac Persistent bleeding requiring surgical intervention Hemorrhage Infection Undiagnosed ectopic pregnancy Medical Abortion: Complications

20. Meta-Analysis: Various Regimens Mifepristone/Misoprostol (< 49 days) 96.0% 100% 75% 50% 25% 2.9% 1.1% 0% Success Incomplete Continuing Abortion Pregnancy Kahn, et al. Contraception 2000

21. The presence of a developing pregnancy 2 weeks after first medication Treatment: uterine aspiration Incidence (meta-analysis): Mifepristone/oral or vaginal misoprostol 1.1% of cases ( 49 days’ gestation) Methotrexate/vaginal misoprostol2.7% of cases ( 49 days’ gestation) Management of Complications: Continuing Pregnancy Kahn, et al. Contraception 2000

22. Perform ultrasound examination if clinically suspected Treatment options Observation and re-evaluation Repeat misoprostol Uterine aspiration Management of Complications: Persistent Gestational Sac/Persistent Bleeding

23. Persistent Gestational Sac

24. Persistent Bleeding

25. Difficult to quantify amount of bleeding Guideline: patients should contact provider if they saturate 2 or more maxipads/hour for 2 consecutive hours Defining clinically significant hemorrhage Drop in hemoglobin/hematocrit Hypovolemia Orthostatic hypotension Timing of heavy bleeding Management of Complications: Hemorrhage

26. Rarely occurs in medical abortion 0.28% - 0.92%1 Rule out retained products of conception Treatment: antibiotics Management of Complications: Infection 1Shannon, et al. Contraception 2004

27. Providers should have established protocols for diagnosis and management Methotrexate > 90% effective Mifepristone, misoprostol not effective treatments Management of Complications: Undiagnosed Ectopic Pregnancy

29. Continuing pregnancy Incomplete abortion unresponsive to medical treatment Orthostatic hypotension Anemia, especially with ongoing blood loss Patient unable to return; no access to emergency services Subjective symptoms unresponsive to medical treatment Patient preference Proposed Criteria for Surgical Intervention in Medical Abortion

30. Emergent Severe hemorrhage occurs SHOULD BE DONE URGENTLY Nonemergent Continuing pregnancy Incomplete abortion without hemorrhage Patient choice CAN BE SCHEDULED AT CONVENIENCE OF PATIENT AND PROVIDER Timing of Surgical Intervention

31. Medical abortion is safe and effective Establish guidelines for management of side effects and complications Side effects are expected Complications may occur but are uncommon Patients should have 24-hour access to backup care Clinicians must have arrangements established for vacuum aspiration, if needed Conclusion

32. Background: safety, definitions, counseling issues “Expected” side effects and their management Complications and their management Case studies Overview

33. Case Study 1 • 23-year-old G2P1 • 200 mg mifepristone PO • 800 µg misoprostol PV (at home) 2 days later • 3 hours after misoprostol, patient complains of severe cramping and bleeding (3 pads/2 hours) • Pretreatment Hct: 37% Optimal management would consist of which of the following? 1. Uterine aspiration 2. Reassurance and treatment with analgesics 3. Methergine, 0.2 mg IM 4. Uterine packing

34. 34-year-old G4P3 6 weeks LMP Medical abortion with mifepristone/misoprostol Calls to report mild vaginal bleeding 2 days after misoprostol Office visit 2 days later Case Study 2 The clinical picture is consistent with which of the following? • . Continuing pregnancy • . Persistent gestational sac • . Retained pregnancy tissue requiring vacuum aspiration

35. Case Study 3 • 25-year-old G1P0 • 42 days’ gestation • Mifepristone/misoprostol • No bleeding after misoprostol • Ultrasound performed 12days after misoprostol,with cardiac activity present Optimal management would consist of which of the following? • . Vacuum aspiration • . Observation • . Methergine, 0.2 mg IM

36. Case Study 4 • 28-year-old G3P0 • 34 days’ gestation • Positive pregnancy test • Pelvic exam normal • Ultrasound obtained Appropriate management consists of which of the following? • . Misoprostol 800 µg vaginally • . STAT -hCG levels • . Laparotomy • . Decline to perform an abortion, as the patient has miscarried

37. Case Study 5 • 30-year-old G1P0 • 12 days status post mifepristone/misoprostol • Reports continuous bleeding since taking misoprostol • No persistent pain • Afebrile (temp 98.70 F) • BP 114/78; HR 74 • Hct: 31% • Ultrasound: widened endometrial stripe (2 cm) Treatment options include all of the following except: 1. Vacuum aspiration 2. Trial of methergine, 0.2 mg IM 3. Repeat mifepristone 4. Expectant management