Obstetrics Book

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Mifepristone and Misoprostol Protocol for Early Pregnancy Loss

Aka: Mifepristone and Misoprostol Protocol for Early Pregnancy Loss, Mifepristone and Misoprostol Protocol for Termination of Pregnancy
  1. Indications
    1. Early Pregnancy Loss (<84 days)
    2. Termination of Pregnancy (<77 days, FDA approved for <70 days)
  2. Contraindications
    1. Adrenal Insufficiency (Mifepristone)
    2. Chronic Corticosteroid use (Mifepristone)
    3. Suspected Ectopic Pregnancy, Septic Abortion or hemodynamic instability
    4. Bleeding Disorder
  3. Protocol
    1. Start: Mifrepristone (Mifeprex) 200 mg orally once
      1. Mifepristone is obtained directly from manufacturer by licensed medical provider
    2. Next: Misoprostol (Cytotec) 800 mcg vaginal, buccal, sublingual 24-48 hours later
      1. Efficacy improves if followed by second dose Misoprostol 800 mcg 4 hours after first
      2. For buccal dosing, hold two of the 200 mcg Misoprostol in each cheek (total 800 mcg) for 30 minutes
      3. For vaginal dosing, insert four of 200 mcg Misoprostol in vagina (total 800 mcg), and lie supine for 30 minutes
    3. Adjunctive, symptomatic management
      1. NSAIDs
      2. Heating pad
      3. Consider Ondansetron for Antiemetic
    4. Precautions for urgent or emergent return
      1. Fever
      2. Foul Vaginal Discharge
      3. Significant abdominal or Pelvic Pain >24 hours after Misoprostol dose
      4. Heavy Vaginal Bleeding (e.g. 4 pads in 4 hours)
      5. Persistent symptoms of ongoing pregnancy
    5. Contraception
      1. May be started after Misoprostol dose
  4. Efficacy
    1. Effectiveness >95% up to 63 day gestation
  5. Adverse Effects
    1. Nausea or Vomiting
    2. Diarrhea
    3. Strong uterine cramping and heavier Vaginal Bleeding follows Misoprostol dose
      1. Onset within several hours
      2. Persists for 3-5 hours
      3. Lighter Vaginal Bleeding may persist for 9-16 days
  6. Complications
    1. Unplanned uterine aspiration required for pain or bleeding (8%)
    2. Significant Hemorrhage requiring transfusion (2%)
    3. Septic Abortion or pelvic infection (1.3%)
    4. Undiagnosed Ectopic Pregnancy
    5. Ongoing pregnancy
  7. Imaging: Obstetric Ultrasound Indications
    1. Confirm Early Pregnancy Loss
    2. Confirm intrauterine pregnancy (not Ectopic Pregnancy)
    3. Assess Gestational age to meet criteria for protocol
      1. Early Pregnancy Loss (<84 days)
      2. Termination of Pregnancy (<77 days, FDA approved for <70 days)
    4. Also obtain for risk of Ectopic Pregnancy
      1. Adnexal Mass
      2. Pelvic Inflammatory Disease
      3. Pregnancy with IUD in place
      4. Adnexal Mass or pain
  8. Labs
    1. Rh Status
      1. Administer RhoGAM if Rh negative
    2. Quantitative bhCG
      1. Obtained to monitor serially to confirm completed Miscarriage
      2. Expect bHCG to fall by 50% in first 24 hours after Misoprostol
      3. Expect bHCG to fall by 80% in first 7 days after Misoprostol
  9. References
    1. MacNaughton (2021) Am Fam Physician 103(8) 473-80 [PubMed]
    2. Schreiber (2018) N Engl J Med 378(23): 2161-70 [PubMed]

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