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Using Misoprostol in early pregnancy in your office

Using Misoprostol in early pregnancy in your office. Dr Konia Trouton Dr Ellen Wiebe FMF, October 2010. Learning objectives. Participants will: Be knowledgeable about the drugs and protocols used for medical abortion and completion of miscarriage

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Using Misoprostol in early pregnancy in your office

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  1. Using Misoprostol in early pregnancy in your office Dr Konia Trouton Dr Ellen Wiebe FMF, October 2010

  2. Learning objectives Participants will: • Be knowledgeable about the drugs and protocols used for medical abortion and completion of miscarriage • Be able to counsel women for medical abortion • Be able to manage side effects and complications

  3. Overview Background Patient selection- who would/could use it? Counseling our patients - pros/cons Protocols Managing side effects/complications Practical issues for service delivery Canadian realities Global perspectives resources

  4. Abortion in Canada • about 100,000/year • Rates stable • 52% performed in clinics • Most done at < 9 weeks GA • <3000 medical abortions • (85% in BC)

  5. Cindy – 25 years old • Cindy comes to you with LMP 6 weeks prior and a positive urine pregnancy test. She is requesting an abortion. What are her choices? 5 5

  6. Medical Abortion Options • Mifepristone (RU486) and misoprostol • Approved by US FDA September 2000 • NOT available in Canada • Methotrexate and misoprostol • Used in countries (like Canada) where RU 486 not available • Misoprostol alone • Common in countries where abortion is illegal – self administration • Easy to use but less effective

  7. Methotrexate • Antimetabolite – folic acid antagonist • Can use IM or PO • 85% efficacy as a single agent and for early ectopic pregnancies • Undetectable in serum within 72 hrs • Small amount secreted in breast milk

  8. Misoprostol • a prostaglandin analogue • Stimulates uterine contraction • Softens the cervix • Also GI effects: nausea, diarrhoea • Sublingual gives highest peak level • more sustained with buccal or vaginal • Expulsion of products of conception

  9. Mifepristone (RU 486)Mechanism of action • Antiprogestin- blocks action of progesterone • Uterine lining breaks down • Increases prostaglandin levels and sensitivity to prostaglandins • Cervix softens • POCs expelled with misoprostol administration

  10. Teratogenicity • Methotrexate • Skeletal anomalies, ambiguous genitalia • Misoprostol • associated with Mobius sequence (skull and limb deformities)  surgical evacuation if unsuccessful • Neither affect future fertility

  11. M&M outcomes • 90-95% success rate up to 49 days GA • 83% success up to 56 days GA • 65-80% occur by day 8 • continuing pregnancy in 1% (<49 days) • oral MTX effective but GI side effects • acceptability high for women who choose it • Lower at higher GA

  12. Misoprostol alone outcomes • Success 80-85% • Continuing pregnancy 4-10% • More prostaglandin side effects (uses higher doses)

  13. Completion of spontaneous abortion • May use M&M or misoprostol alone • Allows more control for the woman and couple than waiting for nature

  14. Patient Selection for MA No more than 7 weeks from LMP CRL of 10mm maximum on ultrasound Compliant with follow up Agrees to surgery if failure No contraindications to methotrexate Hgb >100 Comfortable passing clots/cramps at home Within 1 hr of emergency facility

  15. Exclusions • Intolerance to MTX or misoprostol • Coagulopathy • Immunosuppression • active liver disease (AST > 2 x normal) • active renal disease (Cr > 120) • Hgb < 100, WBC < 3

  16. Pre-abortion workup • Hx/Px • Routine labs • CBC, Rh, +/- hCG, urinalysis • Cervical/vaginal cultures – GC, Chl, Bacterial vaginosis? • (AST, Cr if indication) • Establishing early pregnancy • Dating ultrasound – availability? • Other means

  17. Establishing early pregnancy •  7 weeks AND intrauterine How? • Clinically – LMP and physical exam • Ultrasound • Quantitative hCG

  18. Establishing early pregnancy • LMP alone • About 50% are accurate (Wegienka et al, 2005) • Bimanual examination • US abortion providers 87% correct in classifying GA as < 63 days (only 1% overestimate) (Fielding et al, 2002) • Transvaginal ultrasound • Very accurate dating (within 3 days)

  19. Establishing early pregnancy • Fielding et al Contraception 2002 • For MA up to 63 days with clinical assessment (LMP, Hx and exam) • US not necessary in 60-66% • More likely necessary for GA < 42 days and > 49 days

  20. Establishing early pregnancyValue of hCG • > 25 mIU by 7 days after implantation in 98% • doubles q 1.3-2 days up to 6 weeks • rise slower until peak at 9-10 weeks • if rise < 50% over 48 hours  pregnancy abnormal (99+%) • Discriminatory value 1,500-2,000 mIU • If no gestational sac on TVUS assume ectopic pregnancy until proven otherwise

  21. Establishing early pregnancyValue of hCG Creinin Am J Obstet Gynecol 2001 • Data from 574 women having MA • 49 day hCG cut off 71,000 • PPV 76% (ie 76% of pregnancies < 49 days had hCG below the cutoff) • NPV 91% (ie 91% of pregnancies > 49 days had hCG above the cutoff value)

  22. Absolute indications for ultrasound • LMP uncertain or consistent with gestational age > 7 weeks • Size/date discrepancy • Uncertainty with exam • Adnexal mass or pain • Concern about ectopic pregnancy 24 24

  23. Ultrasound milestones in early pregnancy Gestational sac • seen at 35 days LMP  2 d • grows  1 mm/day Yolk sac • should see with GS 8-10mm (5-6 wks GA) Fetal pole • should see with GS 16mm (6-7 wks GA) Fetal heart • should see with fetal pole 6 mm (about 6½ wks)

  24. Ultrasound & dating table 26 26

  25. Michele aged 25 • Michele come to you with LMP 6 weeks prior and a positive urine pregnancy test. 4 days ago she had some cramping and bleeding and passed a large clot. She is still bleeding slightly but has no pain. On exam her uterus is slightly bulky, non tender and she has no adnexal masses. If she is still pregnant she wants an abortion.

  26. Michele aged 25 • Pelvic ultrasound: empty uterus, no adnexal masses • -hCG: 900 IU • Hgb: 120 • What is your diagnosis? • What do you want to do next?

  27. Follow up! • Ectopic warning • Go to hospital if you have severe, persistent abdominal pain, one sided pain, faintness • serial -hCG

  28. Michele • -hCG 2 days later: 700 IU • What is your diagnosis? • What do you want to do next?

  29. Ectopic Letterie, Arch Gyne Obstet 2000 • serial -hCG in 50 women with miscarriage vs 50 with ectopic • Initial hCG 91-3050 • -hCG rose: 80% of ectopics 35% of miscarriages • no difference in rate of rise

  30. Ectopic • -hCG fell 20 % of ectopics 65 % of miscarriages • fall greater in miscarriages 270 ± 52/d in ectopic 578 ± 28/day in miscarriage • beware plateauing -hCG

  31. Complete miscarriage vs ectopic • Serial -hCG • decrease of >50% over 48 hours indicates miscarriage • lesser decrease mandates continued follow up • plateauing or rising levels  ectopic

  32. Medical AbortionCounselling and Consent

  33. Abortion Counseling • Options (sure decision?) • Issues (religion, any support?) • Informed consent (risks, practicalities) • Contraception

  34. Abortion Counseling • Women more involved in the process of medical abortion as compared to surgical abortion • Preparing women for side effects is a critical component of counseling • Quality of counseling correlates with level of patient satisfaction with abortion care

  35. Pros Done early – no wait lists Private – happens at home Involvement of partner if desired Non invasive May be more accessible Cons Uncertain time line Pain may be severe Bleeding may be heavy Requires several visits Cost of meds Surgical abortion needed in 5-10% Abortion CounselingPros/cons of M&M

  36. Abortion CounselingMedical vs surgical abortion • Surgical abortion • Serious complications rare and usually result from anesthesia or instrumentation of the uterus • Side effects less, vary with medications used • Medical abortion • Serious complications rare • Most side effects are brief and medication-induced: nausea, vomiting, diarrhea, fever • Process of aborting has « side effects »

  37. Consent • Efficacy • Risks/side effects • rare serious events (hemorrage, infection) • Common nuisance side effects • Teratogenicity • Agree to surgical abortion if regimen fails

  38. Health Practitioners Easy access to ultrasound for monitoring Time to explain home treatments, side effects and treatment (more counseling) Access to Rh testing/WinRho administration Able to follow up closely with patients Able to provide/access D&C for failures 24/7 on-call service

  39. Standard Protocol • Initial visit: • Clarify decision to end the pregnancy • Hemoglobin, Rh factor, starting B-hcg • Swab for STI and BV • Ultrasound (if using) • Informed consent • Start post procedure discussion on contraception

  40. Standard protocol • Day 1 • MTX 50mg/m2 (±hCG) (alternate po) • Provide RhIG if indicated • Instructions for home use of medications, Rx for medications, follow-up, emergency contact Prophylactic antibiotic • Day 2-7 • Misoprostol (4x 200mcg tabs) PV, Repeat every 12-24 hours until bleeding (up to ~5 doses) • Alternate: 800 mcg sl q4h x 3 doses

  41. Standard Protocol • Day 8 – 15 • Vaginal ultrasound (or hCG – should drop 80%) • start contraception now if GS is gone • Repeat misoprostol dose if abortion has not occurred

  42. Standard protocol • Day 15 (if needed) • Vaginal ultrasound if not complete at Day 8 (if using hCG - should drop >90% from day from day 1) • If fetal cardiac activity seen • Suction aspiration • If no fetal cardiac activity • Repeat miso • Day 36 (if needed) • exam, urine pregnancy test and ultrasound prn

  43. Standard Procedure- Completion • Completion by ultrasound • Homogeneous endometrial lining, usually <20mm • Patient may still be bleeding! • Completion by Bhcg • Level <50, may take 2-3 weeks to complete • Not necessary if drop appropriate at 8 day and concerns

  44. Absolute indications for ultrasound • No bleeding or cramping • Woman still feels pregnant • Serum β-HCG not declining appropriately (at least 80% drop after one week) • Provider uncertainty 46 46

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

  46. Management of Common Side Effects: Pain • 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

  47. 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

  48. Management of Common Side Effects: Bleeding • Usually exceeds typical menstrual bleeding • If patient saturates 2 maxipads/hour for 4 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 • Greater risk when bleeding at home 1Ashok, et al. Hum Reprod 1998 2Spitz, et al. New Engl J Med 1998

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