1. Medical Education Series © 2005 National Abortion Federation E A R L Y O P T I O N S A PROVIDER’S GUIDE TO MEDICAL ABORTION

2. E A R L Y O P T I O N S A PROVIDER’S GUIDE TO MEDICAL ABORTION EXPECTED SIDE EFFECTS & MANAGEMENT OF COMPLICATIONS MANAGEMENT OF COMPLICATIONS IN MEDICAL ABORTION IN MEDICAL ABORTION

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

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

5. Outstanding Safety Record 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

6. Medical High success rate (about 95-99%) Usually avoids surgical procedure Requires at least two visits Abortion occurs within 24 hours of second medication, for most women May be used in early pregnancy Oral pain medication can be used Some of the process may happen at home Medications cause a process similar to a miscarriage Vacuum Aspiration High success rate (99%) Instruments inserted into the uterus Can be done in one visit Procedure is completed in 5-10 minutes May be used in early pregnancy Anesthesia/Sedation can be used Procedure is done in a medical office or clinic Health care provider performs the procedure Features of Medical Abortion and Vacuum Aspiration

7. Definitions 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

8. Abortion Counseling 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

9. Abortion Counseling 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”

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

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

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

13. Management of Common Side Effects: Pain 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

14. Management of Common Side Effects: Bleeding 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 1 Ashok, et al. Hum Reprod 1998 2 Spitz, et al. New Engl J Med 1998

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

16. Gastrointestinal Side Effects in Medical Abortion 7-268-23Diarrhea 9-1814-44Vomiting 19-4736-67Nausea Methotrexate/ Misoprostol (%) Mifepristone/ Misoprostol (%) Kruse, et al. Am J Obstet Gynecol 2000 Schaff, et al. Contraception 2000

17. Management of Common Side Effects: Fever/Chills 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

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

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

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

21. Kahn, et al. Contraception 2000 Management of Complications: Continuing Pregnancy 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 misoprostol 2.7% of cases (  49 days’ gestation)

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

23. Persistent Gestational Sac

24. Persistent Bleeding

25. Management of Complications: Hemorrhage 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

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

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

28. Indications for Suction Curettage Overall Rate of 2.6% among 4,393 cases 16 decided they would prefer surgical abortion 7 persistent sac 13 to alleviate severe nausea, vomiting, or pain 31%Patient Request (n=36) 5 of these did not take 2 nd misoprostol dose15%Continuing Pregnancy (n=17) 8 within 24 hours of misoprostol 8 additional within 1 st week 53 w/ prolonged or delayed bleeding 1 blood transfusion 53%Bleeding (n=61) Description %Reasons for Curettage (n=116; 2.6%) Allen, et al. Obstet Gynecol 2001

29. Proposed Criteria for Surgical Intervention in Medical Abortion 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

30. Timing of Surgical Intervention 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

31. Conclusion 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

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

33. 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 23-year-old G 2 P 1 200 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% Case Study 1

34. The clinical picture is consistent with which of the following? 1. Continuing pregnancy 2. Persistent gestational sac 3. Retained pregnancy tissue requiring vacuum aspiration Case Study 2 34-year-old G 4 P 3 6 weeks LMP Medical abortion with mifepristone/misoprostol Calls to report mild vaginal bleeding 2 days after misoprostol Office visit 2 days later

35. Optimal management would consist of which of the following? 1. Vacuum aspiration 2. Observation 3. Methergine, 0.2 mg IM Case Study 3 25-year-old G 1 P 0 42 days’ gestation Mifepristone/misoprostol No bleeding after misoprostol Ultrasound performed 12 days after misoprostol, with cardiac activity present

36. 28-year-old G 3 P 0 34 days’ gestation Positive pregnancy test Pelvic exam normal Ultrasound obtained Appropriate management consists of which of the following? 1. Misoprostol 800 µg vaginally 2. STAT  -hCG levels 3. Laparotomy 4. Decline to perform an abortion, as the patient has miscarried Case Study 4

37. 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 30-year-old G 1 P 0 12 days status post mifepristone/misoprostol Reports continuous bleeding since taking misoprostol No persistent pain Afebrile (temp 98.7 0 F) BP 114/78; HR 74 Hct: 31% Ultrasound: widened endometrial stripe (2 cm) Case Study 5

38. E A R L Y O P T I O N S A PROVIDER’S GUIDE TO MEDICAL ABORTION This educational program does not define a standard of care, nor does it dictate an exclusive course of management. It contains recognized methods and techniques of medical care that represent currently appropriate clinical practice. Variations in patient needs and available resources may justify alternative approaches. Laws governing abortion, informed consent, and medical malpractice vary among states. These materials are strictly for informational purposes, and do not constitute legal advice or representation. These materials are not intended as a substitute for the advice of a health care provider. Neither NAF nor its agents are responsible for adverse clinical outcomes that might occur where they are not expressly and directly involved in the role of primary caregiver. This educational program is protected by copyright. Any unauthorized duplication, reproduction, or alteration of the presentations or any part of the presentations contained therein is strictly prohibited. This educational program is intended for the use of the original recipient and his/her agents and cannot be sold, distributed, transmitted or transferred in any form without prior written authorization by the National Abortion Federation. © 2005 National Abortion Federation