Medication Abortion A training module for health professionals Ibis Reproductive Health 1 Ibis Reproductive Health Ibis Reproductive Health aims to improve women’s reproductive health, choices, and autonomy worldwide. Our work includes clinical and social science research, policy analysis, and evidencebased advocacy. Ibis Reproductive Health 2 Objectives Define medication abortion Identify current medication abortion methods and present Mechanisms of action Regimens, efficacy, and safety Eligibility requirements and contraindications Side effects and complications Provide general information on medication abortion methods Outline references and resources Ibis Reproductive Health 3 What is medication abortion? Medication abortion, also known as non-aspiration or non-surgical abortion, refers to a family of safe and effective methods for terminating an early unwanted pregnancy. Through the use of a drug or combination of drugs that are administered orally, vaginally, and/or intramuscularly, medication abortion first causes the pregnancy to terminate and then causes the uterus to expel the products of conception. Ibis Reproductive Health 4 Why “medication abortion”? Non-aspiration or non-surgical abortion is commonly referred to as “medical abortion”. However, this phrase has led to confusion among both providers and the public, as the term “medical” is often associated with physician-based practices and/or medical necessity. “Medication abortion” more accurately represents the family of safe and effective drug-based methods that can terminate an unwanted pregnancy and will be used throughout this presentation. Ibis Reproductive Health 5 Methods of medication abortion Mifepristone and misoprostol Methotrexate and misoprostol Misoprostol alone Medication abortion methods can be used throughout early pregnancy (≤63 days’ gestation) Ibis Reproductive Health 6 Medication abortion Methods of action of the medications Mifepristone Methotrexate Anti-progestin that blocks the action of progesterone Alters the uteral lining Anti-metabolite Interferes with DNA synthesis and cell growth Misoprostol Prostaglandin E analog Stimulates uterine contractions and induces cervical softening 1 Ibis Reproductive Health 7 Medication abortion Additional uses of the medications Mifepristone Methotrexate Labor induction (under investigation) Infertility treatment (under investigation) Treatment of neoplastic diseases Treatment of rheumatoid arthritis Misoprostol Prevention of gastric ulcers Obstetric and gynecologic indications Ibis Reproductive Health 8 Mifepristone/misoprostol regimen Ibis Reproductive Health 9 Mifepristone Worldwide approval Mifepristone Approval (2002) Ibis Reproductive Health 10 Mifepristone/misoprostol regimen General protocol Day 1 (Clinic) Day 2-4 (Home or clinic) Clinician counsels the woman, takes a medical history and performs an exam and lab tests Mifepristone is orally administered Misoprostol is administered Day 7-14 (Clinic) Patient returns to the clinic for follow-up Clinician assesses for the completion of the abortion Ibis Reproductive Health 11 Mifepristone/misoprostol regimens Comparison of protocols French Regimen US: FDA Regimen Evidence-Based Regimen Mifepristone Dosage 600 mg (Day 1) 600 mg (Day 1) 200 mg (Day 1) Misoprostol Dosage 400 µg, PO Or 1mg gemeprost, PV 400 µg, PO 400 µg, PO or 800 µg, PV Gestational Limit ≤ 49 days ≤ 49 days ≤ 63 days Location of misoprostol administration At medical office/clinic At medical office/clinic At medical office/clinic or at home Timing of misoprostol administration Day 2 or 3 Day 3 Day 2, 3, or 4 Timing of initial followup examination Day 10 to 14 Day 14 Day 4 to 14 Number of clinic visits required Three or more Three or more Two or more Ibis Reproductive Health 12 Mifepristone/misoprostol regimen Efficacy and safety Approximately 95% of women will have a successful abortion when using mifepristone/misoprostol within 49 days’ gestation Completion rates appear to decline slightly with increasing durations of pregnancy after 56 days’ gestation Approximately 67% of women will have a complete abortion within four hours of using misoprostol Approximately 90% of women will have a complete abortion within 24 hours of using misoprostol. Ibis Reproductive Health 13 Mifepristone/misoprostol regimen Eligibility for use Non-ectopic pregnancy of ≤63 days’ gestation Absence of contraindications Willingness to undergo vacuum aspiration or dilation and curettage (D&C), if indicated Ibis Reproductive Health 14 Mifepristone/misoprostol regimen Contraindications to use Confirmed or suspected ectopic (extra-uterine) pregnancy Allergy to either mifepristone or misoprostol Presence of an intrauterine device (IUD) Chronic systemic use of corticosteroids Chronic adrenal failure Coagulopathy or current therapy with anticoagulants Inherited porphyria Ibis Reproductive Health 15 Mifepristone/misoprostol regimen Side effects Effects of abortion process Cramping Often described as similar to menstrual cramps Vaginal bleeding Median bleeding time 9-13 days Often described as similar to a heavy period or spontaneous miscarriage Common side effects Nausea Vomiting Diarrhea Headache Dizziness Fever, chills, hot flashes, warmth Ibis Reproductive Health 16 Mifepristone/misoprostol regimen Complications Type of complication Percentage of women Continued pregnancy 1%-5% Incomplete abortion requiring aspiration 1% Hemorrhage requiring aspiration 1%-2% Hemorrhage requiring transfusion 0.1% Ibis Reproductive Health 17 Mifepristone/misoprostol regimen Summary Millions of women worldwide have safely used mifepristone/misoprostol Mifepristone/misoprostol is more than 95% effective in terminating early pregnancies Mifepristone/misoprostol is widely acceptable to both patients and providers Ibis Reproductive Health 18 Methotrexate/misoprostol regimen Ibis Reproductive Health 19 Methotrexate Worldwide availability Methotrexate Availability (2002) Registered Status of the medication is unknown Ibis Reproductive Health 20 Methotrexate/misoprostol regimen Evidence-based protocol Day 1 (Clinic) Day 3-7 (Home) Clinician counsels the woman, takes a medical history and performs an exam and lab tests. Methotrexate is administered either orally (50 mg) or intramuscularly (50 mg/m2) Misoprostol is self-administered vaginally at home. Day 8 (Clinic) Clinician performs a vaginal ultrasound to determine if the abortion is complete. If abortion is complete (75% of women) no further visits are required. If the abortion is incomplete additional misoprostol is given and patient returns On Day 15 if cardiac activity is detected On Day 28-45 if no cardiac activity is detected on ultrasound Ibis Reproductive Health 21 Methotrexate/misoprostol regimen Evidence-based protocol continued Day 15 (Clinic, if necessary) Patient is assessed for continued pregnancy. If cardiac activity is detected, a aspiration termination is performed. If no cardiac activity is detected, patient returns in three weeks. Day 28-45 (Clinic, if necessary) The patient is assessed for continued pregnancy. If the abortion is incomplete (5% of cases), a aspiration termination is performed. Ibis Reproductive Health 22 Methotrexate/misoprostol regimen Efficacy and safety Approximately 95% of women will have a complete abortion when using methotrexate/misoprostol up to 49 days’ gestation. Medication abortion completion rates decline with increasing gestational age Approximately 20% of patients using methotrexate/misoprostol will experience a complete abortion three to four weeks after misoprostol administration. Ibis Reproductive Health 23 Methotrexate/misoprostol regimen Eligibility for use Pregnancy of ≤49 days’ gestation Methotrexate/misoprostol is preferable for women with ectopic pregnancies Absence of contraindications Willingness to undergo vacuum aspiration or dilation and curettage (D&C), if indicated Ibis Reproductive Health 24 Methotrexate/misoprostol regimen Contraindications to use Allergy to either methotrexate or misoprostol Presence of an intrauterine device (IUD) Coagulopathy or current severe anemia Acute or chronic renal or hepatic disease Acute inflammatory bowel disease Uncontrolled seizure disorders. Ibis Reproductive Health 25 Methotrexate/misoprostol regimen Side Effects Effects of abortion process Cramping Often described as similar to menstrual cramps Vaginal bleeding Median bleeding time 2-3 weeks Often described as similar to a heavy period or spontaneous miscarriage Common side effects Nausea Vomiting Diarrhea Headache Dizziness Fever, chills, hot flashes, warmth Oral ulcers Fetal malformations Ibis Reproductive Health 26 Methotrexate/misoprostol regimen Complications (≤49 days’ gestation) Type of complication Percentage of women Continued pregnancy 3-5% Incomplete abortion requiring aspiration 3-5% Hemorrhage requiring aspiration 1%-2% Hemorrhage requiring transfusion 0.1%-0.5% Ibis Reproductive Health 27 Methotrexate/misoprostol regimen Summary Methotrexate/misoprostol is approximately 95% effective in terminating pregnancies ≤49 days’ gestation Methotrexate/misoprostol is the preferred medication abortion method for confirmed or suspected ectopic pregnancies Methotrexate/misoprostol is widely acceptable to both patients and providers Ibis Reproductive Health 28 Misoprostol-only regimen Ibis Reproductive Health 29 Misoprostol Worldwide availability Misoprostol Availability (2002) Ibis Reproductive Health 30 Misoprostol-only regimen Evidence-based protocols No consensus exists on optimal protocol Various regimens, dosing schedules and routes of administration are currently under investigation Most commonly used protocol Vaginal administration of 800 µg of misoprostol If abortion fails, misoprostol dose is repeated every 24 hours, up to three doses Ibis Reproductive Health 31 Misoprostol-only regimen Efficacy and Safety Efficacy varies widely (65%-93%) Efficacy varies by route of administration, dose, dosing schedule, and gestational age Misoprostol-only regimens are not as effective as either mifepristone/misoprostol or methotrexate/misoprostol regimens Ibis Reproductive Health 32 Misoprostol-only regimen Eligibility for use Non-ectopic pregnancy of ≤63 days’ gestation Absence of contraindications Willingness to undergo vacuum aspiration or dilation and curettage (D&C), if indicated Lack of access to either mifepristone or methotrexate Ibis Reproductive Health 33 Misoprostol-only regimen Contraindications for use Confirmed or suspected ectopic pregnancy Allergy to misoprostol Presence of an intrauterine device (IUD) Uncontrolled seizure disorder Inflammatory bowel disease Ibis Reproductive Health 34 Misoprostol-only regimen Side effects Effects of abortion process Cramping Often described as similar to menstrual cramps Often described as more severe than the cramping of either mifepristone/misoprostol or methotrexate/misoprostol regimens Vaginal bleeding Median bleeding time 2 weeks Often described as similar to a heavy period or spontaneous miscarriage Common side effects Nausea Vomiting Diarrhea Headache Dizziness Fever and chills Rashes Pelvic pain Fetal malformations Ibis Reproductive Health 35 Misoprostol-only regimen Complications Approximately 10%-35% of women will require an aspiration intervention Misoprostol-only regimen is less effective in terminating early pregnancy than when used in combination with either mifepristone or methotrexate Ibis Reproductive Health 36 Misoprostol-only regimen Summary Misoprostol used in conjunction with either mifepristone or methotrexate is more effective at terminating early pregnancy than misoprostol alone Efficacy varies widely Optimal regimen has yet to be determined Misoprostol-only regimen is an important alternative for women who do not have access to other medical or aspiration abortion methods Ibis Reproductive Health 37 Medication abortion: General issues Ibis Reproductive Health 38 Medication abortion Comparing the three regimens Regimen Advantages Disadvantages Mifepristone/ misoprostol High efficacy (≈95%) Can be used through 63 days’ gestation Abortion typically occurs within hours of misoprostol administration Mifepristone is often expensive Mifepristone is not available in many countries Can not be used to treat ectopic pregnancies Methotrexate/ misoprostol High efficacy (90%-95%) Can be used through 56 days’ gestation Often less expensive than mifepristone Treats ectopic pregnancies Abortion can occur over a four week period May cause fetal abnormalities in continued pregnancies Efficacy decreases after 49 days’ gestation Misoprostol-only Can be used through 63 days’ gestation Widely available worldwide Often very inexpensive Stable at room temperature Efficacy is variable (65%-90%) Regimen is currently under investigation May cause fetal anomalies in continued pregnancies Can not be used to treat ectopic pregnancies Ibis Reproductive Health 39 Medication abortion Special considerations for early pregnancy termination Determine eligibility for medication abortion Discuss medical and aspiration options Diagnose and accurately date of early pregnancy Inform patients of potential side effects, complications, and follow-up requirements Provide adequate follow-up and post abortion care Aspiration intervention, if necessary Family planning services Ibis Reproductive Health 40 Methods for determining gestational age For all medication abortion methods, accurate pregnancy dating is important Methods for determining gestation age include Last menstrual period Bimanual examination Serum β-hCG testing Ultrasound Ibis Reproductive Health 41 Alternatives to medication abortion Aspiration abortion Types of aspiration abortion Aspiration procedure Manual vacuum aspiration Dilation and curettage (D&C) Cannula is inserted into the uterus Uterine contents are emptied through suction Can be used throughout the first trimester Highly effective (>99%) in terminating pregnancy Ibis Reproductive Health 42 Medication abortion vs. aspiration abortion Advantages and disadvantages Method Advantages Disadvantages Medication abortion Used early during pregnancy Resembles a natural miscarriage Often considered more private Usually avoids aspiration intervention Anesthesia not required High success rates (for mifepristone/misoprostol and methotrexate/misoprostol regimens) Often requires at least two clinic visits Takes days, sometimes weeks to complete Efficacy decreases at later gestational ages Women may see blood clots and the products of conception Mifepristone and/or methotrexate may not be available Mifepristone can be expensive Aspiration abortion High success rate (>99%) May require only one clinic visit Procedure completed within minutes Sedation is available Involves an invasive procedure May not be available very early in pregnancy Often considered to be “less private” Quality of facilities may vary significantly Ibis Reproductive Health 43 Medication abortion Conditions requiring clinical assessment and/or intervention Fever Excessive or prolonged bleeding Incomplete abortion Retained fetal tissue Persistent gestational sac on ultrasound Continued pregnancy Ibis Reproductive Health 44 Medication abortion regimens Acceptability Generally well-accepted by patients who report High satisfaction Desire to use the method again Intention to recommend method to a friend or relative Both mifepristone/misoprostol and methotrexate/misoprostol regimens are wellaccepted by providers Ibis Reproductive Health 45 Medication abortion regimens Best and worst reported features Women report the best features as Ability to avoid surgery and anesthesia Perception that the process is more “natural” Privacy Convenience Women report the worst features as Length and degree of bleeding Number of clinic visits Uncertainty as to whether or not the procedure had resulted in a complete abortion. Ibis Reproductive Health 46 Medication abortion Future directions for research and clinical practice Expand worldwide access to medication abortion medications Establish optimal misoprostol-only regimens Expand programs to educate women, health professionals, and policy makers about medication abortion Train health professionals in medication abortion provision Ibis Reproductive Health 47 Medication Abortion Conclusions Medication abortion regimens have been used by millions of women worldwide to safely and effective terminate early pregnancy Medication abortion regimens expand pregnancy termination options for women and health professionals Medication abortion regimens are highly acceptable to both women and providers Future research is needed to improve regimens and expand services Ibis Reproductive Health 48 Medication Abortion References and resources The Alan Guttmacher Institute: www.agi-usa.org This site provides numerous studies on abortion in the US and worldwide. American College of Obstetricians and Gynecologists: www.acog.org This website provides information on the medical management of abortion and resources on practice guidelines. Ibis Reproductive Health: www.ibisreproductivehealth.org The home page of Ibis Reproductive Health, this site provides information on the organization and contains a database of articles published by staff. Ibis also provides educational materials on medication abortion in English, Arabic, French, and Spanish. IPAS: www.ipas.org IPAS manufactures and distributes manual vacuum aspiration equipment and trains providers in early abortion techniques worldwide. National Abortion Federation: www.earlyoptions.org This site provides medication abortion educational materials for both providers and patients. Population Council: www.popcouncil.org The Population Council provides information on reproductive health issues worldwide, including publications on medication abortion methods and acceptability. 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